TerminatedPhase 1/2

GEN3014 Trial in Relapsed or Refractory Hematologic Malignancies

Stopped: The sponsor has decided to discontinue further development of GEN3014 after a comprehensive review of the data, market landscape, and strategic priorities.

United States, Australia130 participantsStarted 2021-03-09

Plain-language summary

The drug that will be investigated in the study is an antibody, GEN3014. Since this is the first study of GEN3014 in humans, the main purpose is to evaluate safety. In addition to safety, the study will determine the recommended GEN3014 dose to be tested in a larger group of participants and assess preliminary clinical activity of GEN3014. GEN3014 will be studied in relapsed (disease has returned) or refractory (resistant to treatment) multiple myeloma (also known as RRMM) and other blood cancers. The study consists of 3 parts: 1. The Dose Escalation will test increasing doses of GEN3014 to identify a safe dose level to be tested in the other two parts. 2. Expansion Part A will further test the GEN3014 dose determined from the Dose Escalation. 3. Expansion Part B will compare intravenous (IV) GEN3014 with the subcutaneous (SC) daratumumab in ex-US countries. Participants will receive either GEN3014 into the vein or daratumumab under the skin; none will be given placebo. The study duration will be different for the individual participants. Overall, the study may be ongoing up to 5 years after the last participant's first treatment.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria * Must have fresh bone marrow samples collected at Screening for RRMM, R/R AML, and R/R DLBCL with suspected bone marrow involvement. * Dose Escalation phase, Expansion Part A (for MM and AML) and Expansion Part B- Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0, 1, or 2. Expansion Part A (for DLBCL): ECOG PS 0 or 1. * Has acceptable laboratory test results during the Screening period. * A woman of reproductive potential must agree to use adequate contraception during the trial and for 12 months after the last GEN3014 or daratumumab SC administration. * A woman of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-hCG) at Screening and additionally, for Expansion Part B, within 72 hours of the first dose of study treatment prior to dosing. * A woman must agree not to donate eggs (ova, oocytes) for assisted reproduction during the trial and for 12 months after receiving the last dose of GEN3014 or daratumumab SC. * A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control and all men must not donate sperm during the trial and for 12 months after receiving the last dose of GEN3014 or daratumumab SC. Specific for RRMM: * Must have documented multiple myeloma as defined by the criteria below and have evidence of disease progression on the most recent prior treatment regimen based on IMWG criteria: * Pr…

What they're measuring

Dose Escalation: Number of Participants with Dose Limiting Toxicities (DLTs)

Timeframe: Up to 28 days during the first cycle (cycle =28 days)

Dose Escalation: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: From first dose until the end of the safety follow-up period (30 days after last dose; up to 8 years)

Expansion Part A: Objective Response Rate (ORR) of GEN3014

Timeframe: Up to 8 years

Expansion Part B: Objective Response Rate (ORR) of GEN3014 IV vs Daratumumab SC in Anti-CD38 mAb-naive RRMM Participants

Timeframe: Up to 8 years

Trial details

NCT IDNCT04824794

SponsorGenmab

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-30

View on ClinicalTrials.gov More Relapsed or Refractory Multiple Myeloma (RRMM) trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Dose Escalation: Number of Participants with Dose Limiting Toxicities (DLTs)

Timeframe: Up to 28 days during the first cycle (cycle =28 days)

Dose Escalation: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Timeframe: From first dose until the end of the safety follow-up period (30 days after last dose; up to 8 years)

Expansion Part A: Objective Response Rate (ORR) of GEN3014

Timeframe: Up to 8 years

Expansion Part B: Objective Response Rate (ORR) of GEN3014 IV vs Daratumumab SC in Anti-CD38 mAb-naive RRMM Participants

Timeframe: Up to 8 years