This clinical trial is designed to assess the safety, preliminary efficacy, and pharmacokinetics (PK) of DS3790a monotherapy and combination regimens in participants with hematological malignancies.
DS3790a may be effective in the treatment of patients with hematological malignancies. The primary objective of this study will assess the safety and preliminary efficacy of DS3790a monotherapy and combination regimens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
420
Administered as specified in the protocol
Administered as specified in the protocol
Administered as specified in the protocol
Research Site
New York, New York, United States
RECRUITINGAichi Cancer Center Hospital
Nagoya, Japan
RECRUITINGResearch Site
Tokyo, Japan
RECRUITINGNumber of Participants Reporting Dose-limiting Toxicities, Treatment-emergent Adverse Events, Serious Adverse Events, Adverse Events of Special Interest, and Deaths in Participants With Hematological Malignancies
Adverse events (AEs) will be graded using NCI-CTCAE version 5.0.
Time frame: Baseline up to 5 years
Complete Response in Participants With Hematological Malignancies by Blinded Independent Central Review (Cohort A Randomization Optimization Phase, Cohort A Phase 2)
Complete Response (CR) is defined as participants with CR as measured by BICR assessment.
Time frame: Baseline up to 5 years
Complete Response in Participants With Hematological Malignancies by Investigator Assessment (Cohort B Randomization Optimization Phase)
Complete Response (CR) is defined as participants with CR as measured by investigator assessment.
Time frame: Baseline up to 5 years
Objective Response by Investigator Assessment In Participants With Hematological Malignancies
Objective response (OR) is defined as participants with complete response (CR) or partial response (PR) as measured by investigator assessment.
Time frame: Baseline up to 5 years
Complete Response in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation)
Complete response (CR) is defined as participants with CR as best overall response (BOR) as measured by investigator assessment.
Time frame: Baseline up to 5 years
Disease Control in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation)
Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
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Research Site
Tokyo, Japan
RECRUITINGDisease control (DC) is defined as participants with CR, PR or stable disease as BOR as measured by investigator assessment.
Time frame: Baseline up to 5 years
Duration of Complete Response and Duration of Response in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation)
Duration of Complete Response (DoCR) is defined as the time from the date of first documentation of CR to the first documentation of objective tumor progression by investigator assessment or to death due to any cause, whichever occurs first. DoCR will be calculated for responders (CR) only. Duration of Response (DoR) is defined as the time from the date of first documentation of objective response (CR or PR) to the first documentation of objective tumor progression by investigator assessment or to death due to any cause, whichever occurs first. DoR will be calculated for responders (CR or PR) only.
Time frame: Baseline up to 5 years
Time to Response in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation)
Time to Response (TTR) is defined as the time from the date of the start of trial intervention or randomization if randomized, to the date of the first documentation of objective response (CR or PR) by investigator assessment. TTR will be calculated for responders (CR or PR) only.
Time frame: Baseline up to 5 years
Progression-free Survival Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation)
Progression-free Survival (PFS) is defined as time from the date of the start of trial intervention or randomization if randomized, to the date of radiographic disease progression, defined as the first documented objective PD by investigator assessment or death due to any cause.
Time frame: Baseline up to 5 years
Overall Survival Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation)
Overall Survival (OS) is defined as the time from the date of the start of trial intervention or randomization if randomized, to the date of death due to any cause.
Time frame: Baseline up to 5 years