Study of Ubamatamab Alone or With Cemiplimab for Recurrent Ovarian or MUC16+ Cancers
This study is looking at ubamatamab, alone or with cemiplimab, for adults with recurrent ovarian, fallopian tube, primary peritoneal, or endometrial cancer. Researchers want to learn about the safety of these drugs and find the right dose. They will also see how the drugs move through your body (pharmacokinetics) and if they can treat these cancers. The study will also explore if sarilumab or tocilizumab can help prevent or reduce a side effect called Cytokine Release Syndrome (CRS). To join, you must be a woman aged 18 or older with one of these cancers, and for ovarian cancer cohorts, have a specific CA-125 level. The study aims to enroll up to 890 participants.
- Study design
- This interventional study plans to enroll up to 890 participants. It is looking at the safety and effectiveness of ubamatamab alone or in combination with cemiplimab, sarilumab, or tocilizumab.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and side effects will be monitored for ubamatamab monotherapy for up to 2 years. Other specific follow-up durations are not detailed.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of REGN4018 (Ubamatamab) Administered Alone or in Combination With Cemiplimab in Adult Patients With Recurrent Ovarian Cancer or Other Recurrent Mucin-16 Expressing (MUC16+) Cancers
At a glance
Conditions
Where it's being run
52 sites across 31 statesStudy leadership
- Clinical Trial Management · STUDY_DIRECTOR · Regeneron Pharmaceuticals
Who to contact
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What this trial measures
- Number of participants with Dose-limiting toxicity (DLTs) for ubamatamab monotherapyFrom Cycle 1, Day 1 up to 35 days
Dose Escalation Phase
- Number of participants with DLTs for ubamatamab with cemiplimabFrom Cycle 2, Day 1 up to 21 days
Dose Escalation Phase
- Number of participants with Treatment-emergent adverse event (TEAE)s (including immune-related adverse events (imAEs)) for ubamatamab monotherapyUp to 2 years
Dose Escalation Phase
- Number of participants with TEAEs (including imAEs) for ubamatamab with cemiplimabUp to 2 years
Dose Escalation Phase
- Number of participants with serious adverse events (SAEs) for ubamatamab monotherapyUp to 2 years
Dose Escalation Phase
- Number of participants with SAEs for ubamatamab with cemiplimabUp to 2 years
Dose Escalation Phase
- Number of deaths for ubamatamab monotherapyUp to 2 years
Dose Escalation Phase
- Number of deaths for ubamatamab with cemiplimabUp to 2 years
Dose Escalation Phase
- Number of participants with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) for ubamatamab monotherapyUp to 2 years
Dose Escalation Phase
- Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for ubamatamab with cemiplimabUp to 2 years
Dose Escalation Phase
- Concentration of ubamatamab in serum over time for ubamatamab monotherapyUp to 2 years
Dose Escalation Phase
- Concentration of ubamatamab in serum over time for ubamatamab with cemiplimabUp to 2 years
Dose Escalation Phase
- Objective response rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for ubamatamab monotherapyUp to 2 years
Dose Expansion Phase
- ORR defined by RECIST 1.1 for ubamatamab with cemiplimabUp to 2 years
Dose Expansion Phase