A First-in-Human Trial of DS3790a in Participants With Hematological Malignancies
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaiichi Sankyo
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Sign and date the ICF, prior to the start of any trial-specific procedures.
Adults >=18 years at the time the ICF is signed.
History of one of the histologically documented hematologic malignancies according to the 5th edition of WHO classification as specified in the protocol.
NHL participants only: Agree to provide baseline tumor tissue samples as specified in the protocol.
Disqualifiers
None
Trial design
Design model
Sequential
Treatments tested in this trial
DS3790a
DrugAdministered as specified in the protocol
Combination drug
DrugAdministered as specified in the protocol
Combination drug
DrugAdministered as specified in the protocol
Treatment groups
420 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Monotherapy Dose Escalation PhaseExperimental treatment 1 intervention
Group B: Monotherapy Dose Expansion PhaseExperimental treatment 1 intervention
Group C: Cohort A Combination Dose-escalation PhaseExperimental treatment 2 interventions
Group D: Cohort A Randomization/Optimization PhaseExperimental treatment 2 interventions
Group E: Cohort A Phase 2Experimental treatment 2 interventions
Group F: Cohort B Combination Dose-escalation PhaseExperimental treatment 2 interventions
Group G: Cohort B Randomization/Optimization PhaseExperimental treatment 2 interventions
Group H: Standard of CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 years2
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 years3
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 yearsSecondary outcomes
1
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 years2
Complete Response in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Dose Expansion, and Cohorts A and B 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 years3
Disease Control in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Dose Expansion, and Cohorts A and B Dose Escalation)
Disease 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 years4
Duration of Complete Response and Duration of Response in Participants With Hematological Malignancies by Investigator Assessment (Monotherapy Dose Escalation, Dose Expansion, and Cohorts A and B 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 yearsSponsors and contacts
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Source ClinicalTrials.gov