A Phase 1/2, Multicenter, Open-Label, Multi-Cohort, First-in Human Trial of DS3790a, for Hematological Malignancies
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.
Arms & interventions
- DrugDS3790a
Administered as specified in the protocol
- DrugCombination drug
Administered as specified in the protocol
- DrugCombination drug
Administered as specified in the protocol
Outcome measures
Primary
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
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
Secondary
Objective Response by Investigator Assessment In Participants With Hematological Malignancies
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)
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)
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)
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 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)
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)
Time frame: Baseline up to 5 years
Eligibility criteria
Study locations (1)
Research Site
New York, New York, 10065