A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies
- Conditions
- Hematological Malignancies
- Interventions
- Drug: DS3790aDrug: Combination drug
- Registration Number
- NCT07220616
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 420
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Monotherapy Dose Escalation Phase DS3790a Participants with hematological malignancies who received DS3790a monotherapy. Monotherapy Dose Expansion Phase DS3790a Participants with hematological malignancies who received DS3790a monotherapy. Cohort A Combination Dose-escalation Phase DS3790a Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen. Cohort A Combination Dose-escalation Phase Combination drug Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen. Cohort A Randomization/Optimization Phase DS3790a Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen. Cohort A Randomization/Optimization Phase Combination drug Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen. Cohort A Phase 2 DS3790a Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen. Cohort A Phase 2 Combination drug Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen. Cohort B Combination Dose-escalation Phase DS3790a Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen. Cohort B Combination Dose-escalation Phase Combination drug Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen. Cohort B Randomization/Optimization Phase DS3790a Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen. Cohort B Randomization/Optimization Phase Combination drug Participants with hematological malignancies who received DS3790a monotherapy and selected combination regimen. Standard of Care Combination drug Participants with hematological malignancies who received standard of care (SoC).
- Primary Outcome Measures
Name Time Method Number 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 Baseline up to 5 years Adverse events (AEs) will be graded using NCI-CTCAE version 5.0.
Complete Response in Participants With Hematological Malignancies by Blinded Independent Central Review (Cohort A Randomization Optimization Phase, Cohort A Phase 2) Baseline up to 5 years Complete Response (CR) is defined as participants with CR as measured by BICR assessment.
Complete Response in Participants With Hematological Malignancies by Investigator Assessment (Cohort B Randomization Optimization Phase) Baseline up to 5 years Complete Response (CR) is defined as participants with CR as measured by investigator assessment.
- Secondary Outcome Measures
Name Time Method Objective Response by Investigator Assessment In Participants With Hematological Malignancies Baseline up to 5 years Objective response (OR) is defined as participants with complete response (CR) or partial response (PR) as measured by investigator assessment.
Complete Response in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation) Baseline up to 5 years Complete response (CR) is defined as participants with CR as best overall response (BOR) as measured by investigator assessment.
Disease Control in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation) Baseline up to 5 years Disease control (DC) is defined as participants with CR, PR or stable disease as BOR as measured by investigator assessment.
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) Baseline up to 5 years 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 to Response in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation) Baseline up to 5 years 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.
Progression-free Survival Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation) Baseline up to 5 years 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.
Overall Survival Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Cohort A Combination Dose Escalation, Cohort B Combination Dose Escalation) Baseline up to 5 years 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.