A Phase 1/2, Multicenter, Open-Label, Multi-Cohort, First-in Human Trial of DS3790a, a DXd-ADC targeting CD37, for Hematological Malignancies.

Conditions

Hematological Malignancies

Brief summary

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., 2. 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 Blinded Independent Central Review assessment., 3. 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.

Related papers

No related papers found yet.

Interventions

DRUGEPCORITAMAB

DRUGRITUXIMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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., 2. 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 Blinded Independent Central Review assessment., 3. 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.	—

Measure

Time frame

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., 2. 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 Blinded Independent Central Review assessment., 3. 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.

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Outcome results

None listed