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A study of mirabegron in young children with neurogenic detrusor overactivity

Mirabegron in Young Children Study | Astellas Clinical Trials

A study to learn how [14C]ASP0367 is processed by the body in healthy men

14C ASP0367 In Males Study | Astellas Clinical Trials

A Study of Gilteritinib (ASP2215) Combined with Chemotherapy in Children, Adolescents and Young Adults with FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

Gilteritnib and Chemotherapy Study | Astellas Clinical Trials

A study to find the best dose of ASP5354 to show lymph nodes in people with breast cancer or melanoma during surgery

ASP5354 to Show Lymph Nodes Study | Astellas Clinical Trials

A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)

Intravesical Enfortumab Vedotin for Bladder Cancer Study | Astellas Clinical Trials

A study of the safety and tolerability of ASP7317 in adults who are losing their clear, sharp central vision due to geographic atrophy secondary to dry age-related macular degeneration

ASP7317 for Geographic Atrophy Study | Astellas Clinical Trials

A Study to Assess the Antitumor Activity, Safety, Pharmacokinetics and Biomarkers of Zolbetuximab (IMAB362) in Participants with Claudin (CLDN) 18.2 Positive, Metastatic or Advanced Unresectable Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Zolbetuximab Study | Astellas Clinical Trials

A Study of an Intratumoral Oncolytic Virus in Patients with Advanced Metastatic Solid Tumors

Intratumoral Oncolytic Virus Study | Astellas Clinical Trials

A Study to Assess ASP0598 Otic Solution Following Topical Application in the Ear in Subjects with Chronic Tympanic Membrane Perforation (CTMP)

ASP058 Otic Solution Study | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with primary mitochondrial myopathy

ASP0367 Study for Primary Mitochondrial Myopathy | Astellas Clinical Trials

A study of ASP2138 in adults with stomach cancer or pancreatic cancer

ASP2138 Study for Stomach or Pancreatic Cancer | Astellas Clinical Trials

A study about how ASP5354 affects the body in healthy adults and in adults whose kidneys do not work well

ASP5354 for Healthy Adults and Adults with Poor Kidneys | Astellas Clinical Trials

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Prostate Cancer Study for Previous Participation in Enzalutamide  | Astellas Clinical Trials

A Study to Assess the Efficacy and Safety of IMAB362 in Combination with Nab-Paclitaxel and Gemcitabine (Nab-P + GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma

IMAB362 with Nab P and GEM Study for Pancreatic Cancer  | Astellas Clinical Trials

A study of gilteritinib, venetoclax and azacitidine as a combined treatment for people newly diagnosed with acute myeloid leukemia

Gilteritinib Venetoclax and Azacitidine Study for Acute Myeloid Leukemia | Astellas Clinical Trials

A Study Investigating the Safety, Tolerability and Efficacy of ASP7517 in Subjects with Relapsed/Refractory Acute Myeloid Leukemia (AML) and Relapsed/Refractory Higher Risk Myelodysplastic Syndrome (MDS)

ASP7517 for Acute Myeloid Leukimia | Astellas Clinical Trials

A study to evaluate ASP0367 in participants with reduced maximum oxygen uptake due to poor systemic oxygen extraction

ASP0367 for Reduced Maxiumum Oxygen Uptake Study | Astellas Clinical Trials

A study of ASP3082 in adults with previously treated solid tumors

ASP3082 for Solid Tumors Study | Astellas Clinical Trials

A Study of ASP1570 in adults with locally advanced or metastatic solid tumors

ASP1570 for Advanced or Metastatic Tumors Study | Astellas Clinical Trials

Study of ASP7517 Alone and with Pembrolizumab in Participants with Advanced Solid Tumors Expressing WT1 Antigen

ASP7517 with Pembrolizumab Study | Astellas Clinical Trials

A Safety Surveillance Study in Subjects with Macular Degenerative Disease Treated with Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy

Macular Degenerative Disease Study | Astellas Clinical Trials

A study to evaluate mirabegron in pediatric participants from 5 to less than 18 years of age with overactive bladder (OAB)

Mirabegron Study in Children with OAB Study | Astellas Clinical Trials

Study of ASP0739 Alone and with Pembrolizumab in Advanced Solid Tumors with NY-ESO-1 Expression Participants

ASP0739 with Pembrolizumab Study For Solid Tumors| Astellas Clinical Trials

A study of ASP0367 in people with kidneys that do not work well and in healthy people

ASP0367 Study for Adults with Poor Kidneys | Astellas Clinical Trials

Enfortumab vedotin and pembrolizumab vs. chemotherapy alone in untreated locally advanced or metastatic urothelial cancer

Enfortumab Vedotin and Pembrolizumab vs Chemotherapy Study | Astellas Clinical Trials

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Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under “Sponsor Specific Details for Astellas.”

Participants with Relapsed/Refractory (R/R) solid tumors known to express New York esophageal squamous cell carcinoma 1 (NY-ESO-1) received intravenous (IV) infusion of ASP0739 (human embryonic kidney cell [HEK293] transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^7 cells/milliliters (mL) at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a partial response (PR) or stable disease (SD) (1 cycle= 28 days). .

Participants with R/R solid tumors known to express NY-ESO-1 received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).

Participants with synovial sarcoma (SS), myxoid/round cell liposarcoma (MRCL), ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, non-small cell lung cancer [NSCLC] adenocarcinoma and squamous cell and esophageal squamous cell carcinoma [ESCC]) received IV infusion of ASP0739 (HEK293 transfected with a lentiviral vector that is encoding the target antigen NY-ESO-1) at a dose of 1x10^8 cells/mL at 4 to 6 mL/minute infusion rate on day 1 of each cycle for a total of 4 doses; an additional 2 doses was administered in participants with a PR or SD (1 cycle= 28 days).

Redacted CSR Synopsis [English]

Plain Language Summary [English]

Redacted Protocol [English]

Redacted SAP [English]

The purpose of this study was to evaluate the safety, and tolerability of ASP0739, when administered as a single agent and in combination with pembrolizumab. 
This study also evaluated the clinical response and other measures of anticancer activity of ASP0739 when administered as a single agent and in combination with pembrolizumab based on central and local assessment.

The study comprised of 2 phases. Phase 1 (dose escalation) included participants with solid tumors known to express New York esophageal squamous cell carcinoma 1 (NY-ESO-1).  Phase 2 (ASP0739 as single agent and in combination with pembrolizumab) included participants with relapsed/refractory Synovial Sarcoma (SS), myxoid/round cell liposarcoma (MRCL), and ovarian cancer who had not responded to Standard of Care (SOC) or were ineligible for standard therapy.  Phase 2 single agent also included a cohort of participants with select solid tumors known to express NY-ESO-1 (melanoma, Non Small Cell Lung Cancer-adenocarcinoma [NSCLC], squamous cell and esophageal squamous cell carcinoma [ESCC]). Japanese participants were only enrolled into the monotherapy arm of the dose expansion cohort.

CN CDE Number

EudraCT Number

jRCT Number

NCT ID

Patient Level Data

Product ST Name

Therapeutic Area

Link to results and other applicable study documents on the Astellas Clinical Trials website

Link to plain language summary of the study on the Trial Results Summaries website

City of Hope

Northwestern University Robert H. Lurie Comprehensive Cancer Center

University of Miami

Brown University

The University of Chicago Medicine

Oregon Health & Science University

NYU Perlmutter Cancer Center

A Phase 1/2 Open-label Study Investigating the Safety, Tolerability and Efficacy of ASP0739 as a Single Agent and in Combination with Pembrolizumab in Patients with Advanced Solid Tumors known to Express NY-ESO-1

A DLT is defined as any of the following occurring within 28 days of the first dose on cycle 1 day 1 (C1D1) considered related to IP.

Grade (Gr) ≥ 2 autoimmune reaction; Gr 3 immune-related adverse events (irAEs) not resolving to Gr ≤ 1 in 3-5 days; Gr 4 irAEs; Gr ≥ 3 non-hematological AEs not resolving to Gr ≤ 2 within 72 hours of onset; Gr 4 neutropenia; Gr 3 febrile neutropenia; Gr 4 thrombocytopenia; Gr 3 anemia/thrombocytopenia with transfusion; Gr 4 anemia; aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 5 x upper limit of normal (ULN) (Gr ≥ 3) without liver metastases; AST/ALT > 8 x ULN with liver metastases; Confirmed Hy's Law; Gr ≥ 3 liver function test (LFT) abnormality; Gr 5 toxicity; > 2 week delay in cycle 2 due to treatment-related toxicity.

A DLT is defined as any of the following occurring within 28 days of the first dose on C1D1 considered related to IP.

Gr ≥ 2 autoimmune reaction; Gr 3 irAEs not resolving to Gr ≤ 1 in 3-5 days; Gr 4 irAEs; Gr ≥ 3 non-hematological AEs not resolving to Gr ≤ 2 within 72 hours of onset; Gr 4 neutropenia; Gr 3 febrile neutropenia; Gr 4 thrombocytopenia; Gr 3 anemia/thrombocytopenia with transfusion; Gr 3 thrombocytopenia with hospitalization; Gr 4 anemia; AST/ALT > 5 x ULN (Gr ≥ 3) without liver metastases; AST/ALT > 8 x ULN with liver metastases; Confirmed Hy's Law; Total Bilirubin > 3 x ULN (Gr ≥ 3); Gr ≥ 3 LFT abnormality; Gr 5 toxicity; > 2 week delay in cycle 2 due to treatment-related toxicity; Gr ≥ 2 pneumonitis; Gr ≥ 2 encephalopathy, meningitis, motor/sensory neuropathy; Guillain-Barre syndrome/myasthenic syndrome/myasthenia gravis; Infusion-related reaction requiring infusion discontinuation.

An AE is any untoward medical occurrence in a participant temporally associated with the use of study IP, whether or not considered related to the study IP, and other study treatments. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study IP and other study treatments. This includes events related to the comparator and events related to the (study) procedures. AEs will be graded using NCI-CTCAE version 5.0.

An AE is considered “serious” if the event results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect; other medically important events.

Number of participants with potentially clinically significant laboratory values.

Number of participants with potentially clinically significant 12-lead ECG values.

Number of participants with potentially clinically significant vital sign values.

Number of participants with potentially clinically significant physical exam values.

The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.

iORR is defined as the proportion of participants for each dose level whose best overall response is rated as confirmed Complete Response (iCR) or Partial Response (iPR) per iRECIST by Independent Central Review.

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

ECOG Scale was used to assess performance status. Grades: 0: Fully active, able to carry on all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory, able to carry out work of light nature. 2: Ambulatory, capable of self-care, unable to carry out work activities. Up and about more than 50% waking hours. 3: Capable of limited self-care, confined to bed/chair more than 50% waking hours. 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed/chair. 5: Dead. Only participants with ECOG grades were reported.

Number of participants with Eastern Cooperative Oncology Group (ECOG) Performance Status

Study Specific Characteristic

Safety Analysis Set (SAF). All participants who took at least 1 dose of the investigational product (IP).

DLT was defined as any event occurring within 28 days of first dose on C1D1 and graded as: 
•Grade (GR) ≥2 autoimmune reaction
•GR 3 Immune related AEs (irAEs) that did not resolve to GR ≤1 in 3 to 5 days, febrile neutropenia with or without infection, thrombocytopenia with bleeding requiring transfusion, anemia requiring transfusion
•GR 4 irAEs, neutropenia, thrombocytopenia, anemia
•GR ≥3 non-hematological AE that did not resolve to GR ≤2 within 72 hours of onset, liver function test abnormality lasting ≥7 days
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 × upper limit of normal (ULN; GR≥3) without liver metastases and 8 × ULN in participants with liver metastases, AST or ALT >3 × ULN and total bilirubin (TBL) >2 × ULN (in participants with, Gilbert syndrome: AST or ALT >3 × ULN and direct bilirubin >1.5) (confirmed Hy’s Law)
•GR 5 toxicity, Prolonged delay (>2 weeks) in initiating cycle 2 due to treatment-related toxicity.

DLT Evaluation Analysis Set (DEAS).The DEAS was defined as all participants in SAF excluding participants who met any of the following criteria:
• Participant was discovered to have enrolled without fully satisfying eligibility criteria.
• Participant received less than the planned dose in cycle 1 for reasons other than DLT.
• Participant had no DLT and withdrew from the study before the end of DLT evaluation period.

Number of participants with Dose Limiting Toxicities (DLTs)

TEAEs

SAEs

An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable & unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An AE was considered “serious” if, it resulted in any of the following outcomes: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly, or birth defect; requires inpatient hospitalization; or leads to prolongation of hospitalization; other medically important events. A treatment-emergent adverse event (TEAE) was defined as an AE observed after the date of first dose until 30 days after the last dose.

Number of Participants with Treatment Emergent Adverse Events (TEAEs) & Serious Adverse Events (SAEs)

Grade 0

Grade 1

Grade 2

Grade 3

Grade 4

Grade 5

The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light
or sedentary nature, e.g., light house work, office work.
2 - Ambulatory and capable of all self-care, but unable to carry out any work activities.
Up and about more than 50% of waking hours.
3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
4 -  Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
5 -Dead.

Number of participants with  ECOG performance status at C1D2

Number of participants with  ECOG performance status at C1D8

Number of participants with  ECOG performance status at CID15

Number of participants with  ECOG performance status at CID22

Number of participants with  ECOG performance status at C2D1

Number of participants with  ECOG performance status at C2D2

Number of participants with  ECOG performance status at C2D8

Number of participants with  ECOG performance status at C2D15

Number of participants with  ECOG performance status at C2D22

Number of participants with  ECOG performance status at C3D1

Number of participants with  ECOG performance status at C3D8

Number of participants with  ECOG performance status at C3D15

Number of participants with  ECOG performance status at C3D22

Number of participants with  ECOG performance status at C4D1

Number of participants with  ECOG performance status at C4D8

Number of participants with  ECOG performance status at C4D15

Number of participants with  ECOG performance status at C4D22

Number of participants with  ECOG performance status at C5D1

Number of participants with  ECOG performance status at C5D15

Number of participants with  ECOG performance status at C6D1

Number of participants with  ECOG performance status at C6D15

The ECOG Scale was used to assess performance status.
Grade Description:
0 - Fully active, able to carry on all pre disease performance without restriction.
1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light
or sedentary nature, e.g., light house work, office work.
2 - Ambulatory and capable of all self-care, but unable to carry out any work activities.
Up and about more than 50% of waking hours.
3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.
4 -  Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.
5 -Dead.
EOT visit was 7 days after last dose.

Number of participants with  ECOG performance status at end of treatment (EOT) visit

Number of participants with  ECOG performance status at Safety follow up 30 days

Number of participants with  ECOG performance status at Safety follow up 60 days

Number of participants with  ECOG performance status at Safety follow up 90 days

The dose recommended for use in phase 2 studies was analyzed on the basis of the safety, tolerability, and preliminary pharmacokinetic (PK) and efficacy data obtained in phase 1 studies.

Recommended phase 2 dose (RP2D)

iORR was defined as the percentage of participants for each dose level whose best overall response is rated as  complete response (iCR) or partial response (iPR) per iRECIST.  iORR assessments included:
● iORR with confirmed response 
● iORR with unconfirmed response 

iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 millimeter (mm) in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.

Due to early termination of the study, sponsor decided not to collect data for endpoints that were assessed by independent central review, thus data was not reported.

Objective Response Rate per Immune Response Evaluation Criteria in Solid Tumors (iRECIST) (iORR) by Independent Central Review

Confirmed response

Unconfirmed response

ORR was defined as the percentage of participants for each dose level whose best overall response is rated as CR or PR per RECIST v1.1. ORR assessment included:
ORR with confirmed response
ORR with unconfirmed response

Participants who had CR or PR were considered to have confirmed response, and participants who did not meet this criterion were considered to have unconfirmed response.
CR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be <10 mm in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.

Response Analysis Set (RAS): The response analysis consisted of all participants who were enrolled and received at least one dose of IP and had at least one post baseline primary efficacy measurement.

Objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (ORR) by Investigator Assessment

iDCR was defined as the percentage of participants for each dose level whose best overall response is rated as confirmed and unconfirmed iCR, iPR or stable disease (iSD) per iRECIST.
iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. SD was defined as neither sufficient shrinkage to qualify for iPR nor sufficient increase to qualify for progressive disease.
Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
Participants who had CR or PR were considered to have confirmed response, and participants who did not meet this criterion were considered to have unconfirmed response.

Disease Control Rate per iRECIST (iDCR) by Investigator Assessment

DCR is defined as the percentage of participants for each dose level whose best overall response is rated as confirmed CR, PR or SD per RECIST v1.1.CR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease.
Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.

Disease Control Rate per RECIST v1.1 (DCR) by Investigator Assessment

iPFS is defined as the time from the date of first dose until death from any cause or radiographic disease progression assessed per iRECIST by independent central review.

Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.

Progression-Free Survival per iRECIST (iPFS) by Independent Central Review

iPFS is defined as the time from the date of first dose until death from any cause or radiographic disease progression assessed per iRECIST by investigator assessment.

Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.

FAS with available data analyzed. The dose level utilized during the expansion phase was the recommended phase 2 dose (RP2D), which was carefully selected from the dose escalation phase and a pooled population was used to estimate time-to-event efficacy endpoints for a comprehensive overview of the treatment's effectiveness

iPFS per iRECIST by Investigator Assessment

PFS is defined as the time from the date of first dose until death from any cause or radiographic disease progression assessed per RECIST v1.1 by investigator assessment.Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started

FAS with available data analyzed. The dose level utilized during the expansion phase was the RP2D, which was carefully selected from the dose escalation phase and a pooled population was used to estimate time-to-event efficacy endpoints for a comprehensive overview of the treatment's effectiveness.

Progression-Free Survival per RECIST v1.1 (PFS) by Investigator Assessment

OS is defined as the time from the date of first dose until the date of death from any cause (death date – first dose date + 1). For a participant who is not known to have died by the end of study follow-up, OS is censored at the date of last contact (date of last contact – first dose date + 1).

FAS. The dose level utilized during the expansion phase was the RP2D, which was carefully selected from the dose escalation phase and a pooled population was used to estimate time-to-event efficacy endpoints for a comprehensive overview of the treatment's effectiveness.

Duration of Overall Survival (OS)

iDOR as per iRECIST was defined as the time from the date of the first response iCR/iPR (whichever is first recorded) to the date of radiographical progression or date of censoring. iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.

Due to early termination of the study, sponsor decided not to collect data for this endpoint, thus data was not reported.

Duration of Response per iRECIST (iDOR)

DOR as per RECIST 1.1 was defined as the time from the date of the first response CR/PR (whichever is first recorded) to the date of radiographical progression or date of censoring.
CR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.

Duration of Response per RECIST (DOR) v1.1

iORR was defined as the percentage of participants for each dose level whose best overall response is rated as iCR or iPR per iRECIST.  iORR assessments included:
● iORR with confirmed response 
● iORR with unconfirmed response 

iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be <10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
Participants who had CR or PR were considered to have confirmed response, and participants who did not meet this criterion were considered to have unconfirmed response.

ORR per iRECIST (iORR) by Investigator Assessment

Phase 1: Dose escalation (168 days)

Phase 2: Dose expansion (168 days)

Participants who met all inclusion criteria and none of the exclusion criteria were enrolled in the study. Study was terminated at dose expansion monotherapy after the comprehensive assessment of other studies that indicated the lack of sufficient monotherapy activity, therefore, team decided to terminate the study.

Clinical Transparency

ORR is defined as the proportion of participants for each dose level whose best overall response is rated as Complete Response (CR) or Partial Response (PR) per RECIST v1.1.

iDCR is defined as the proportion of participants for each dose level whose best overall response is rated as confirmed iCR, iPR or stable disease (SD), per iRECIST.

DCR is defined as the proportion of participants for each dose level whose best overall response is rated as confirmed CR, PR or stable disease (SD), per RECIST v1.1.

iPFS is defined as the time from the start of the study treatment until death from any cause or radiographic disease progression assessed per iRECIST, whichever comes first, as assessed by Independent Central Review.

iPFS is defined as the time from the start of the study treatment until death from any cause or radiographic disease progression assessed per iRECIST, whichever comes first, as assessed by local assessment.

PFS is defined as the time from the start of the study treatment until death from any cause or radiographic disease progression assessed per RECIST v1.1, whichever comes first, as assessed by independent central review.

PFS is defined as the time from the start of the study treatment until death from any cause or radiographic disease progression assessed per RECIST v1.1, whichever comes first, as assessed by local assessment.

OS is defined as the time  from the date of first dose until the date of death from any cause.

iDOR will be calculated only for the subgroup of participants with confirmed response iCR/iPR per iRECIST, as assessed by Independent Central Review.

iDOR will be calculated only for the subgroup of participants with confirmed response iCR/iPR per iRECIST, as assessed by local assessment.

DOR will be calculated only for the subgroup of participants with confirmed response CR/PR per RECIST v1.1, as assessed by Independent Central Review.

DOR will be calculated only for the subgroup of participants with confirmed response CR/PR per RECIST v1.1, as assessed by local assessment.

iORR is defined as the proportion of participants for each dose level whose best overall response is rated as confirmed iCR or iPR, by local assessment.