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A Phase 1/2 Study of REGN4018 (Ubamatamab), a MUC16xCD3 Bispecific Antibody, Administered Alone or in Combination with Cemiplimab in Patients with Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-510783-23-00
Acronym
R4018-ONC-1721
Enrollment
237
Registered
2024-06-25
Start date
2020-10-29
Completion date
Unknown
Last updated
2025-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cancer, Endometrial Cancer

Brief summary

In the Dose Escalation Phase: Number of participants with Dose-limiting toxicity (DLTs) for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Escalation Phase: Number of participants with Treatment-emergent adverse event (TEAE)s (including immune (imAEs)) for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Escalation Phase: Number of participants with serious adverse events (SAEs) for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Escalation Phase: Number of deaths for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Escalation Phase: Number of participants with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Escalation Phase: Concentration of REGN4018 in serum over time for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Expansion Phase: Objective response rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for ubamatamab monotherapy and in combination with cemiplimab

Detailed description

In the Dose Escalation Phase: ORR based on RECIST 1.1 for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Expansion Phase: Number of participants with TEAEs (including imAEs) for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Expansion Phase: Number of participants with SAEs for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Expansion Phase: Number of deaths for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Expansion Phase: Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Expansion Phase: Concentration of ubamatamab in serum over time for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Expansion Phase: Change from baseline in QoL as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 GHS/QoL score for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Expansion Phase: Change from baseline in physical functioning as measured by the EORTC QLQ-C30 physical functioning score for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Expansion Phase: Change from baseline in abdominal symptoms as measured by the Measure of Ovarian Symptoms and Treatment (MOST)-Abdominal index score (Not applicable to Endometrial Cancer Cohort) for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Expansion Phase: Time to deterioration in GHS/QoL, physical functioning, and abdominal symptoms for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Expansion Phase: Change from baseline in QoL as measured by EQ-5D for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Escalation and Dose Expansion Phase: ORR based on iRECIST for ubamatamab monotherapy and with cemiplimab, In the Dose Escalation and Dose Expansion Phase: Best overall response (BOR) based on RECIST 1.1 and iRECIST for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Escalation and Dose Expansion Phase: Duration of response (DOR) based on RECIST 1.1 and iRECIST for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Escalation and Dose Expansion Phase: Disease control rate based on RECIST 1.1 and iRECIST for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Escalation and Dose Expansion Phase: Progression-free survival (PFS) based on RECIST 1.1 and iRECIST for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Escalation and Dose Expansion Phase: Complete Response (CR) rate for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Escalation and Dose Expansion Phase: Cancer antigen-125 (CA-125) response for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Escalation and Dose Expansion Phase: Presence or absence of anti-drug antibodies against ubamatamab and cemiplimab

Interventions

DRUGKevzara 175 mg/ml solution for injection
DRUGLIBTAYO 350 mg concentrate for solution for infusion.
DRUGTOCILIZUMAB
DRUGSarilumab
DRUGCEMIPLIMAB

Sponsors

Regeneron Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
In the Dose Escalation Phase: Number of participants with Dose-limiting toxicity (DLTs) for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Escalation Phase: Number of participants with Treatment-emergent adverse event (TEAE)s (including immune (imAEs)) for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Escalation Phase: Number of participants with serious adverse events (SAEs) for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Escalation Phase: Number of deaths for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Escalation Phase: Number of participants with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Escalation Phase: Concentration of REGN4018 in serum over time for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Expansion Phase: Objecti

Secondary

MeasureTime frame
In the Dose Escalation Phase: ORR based on RECIST 1.1 for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Expansion Phase: Number of participants with TEAEs (including imAEs) for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Expansion Phase: Number of participants with SAEs for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Expansion Phase: Number of deaths for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Expansion Phase: Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Expansion Phase: Concentration of ubamatamab in serum over time for ubamatamab monotherapy and in combination with cemiplimab, In the Dose Expansion Phase: Change from baseline in QoL as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 GHS/QoL

Countries

Belgium, France, Italy, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026