ubamatamab (REGN4018)

P2, N=40, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting

P2, N=40, Not yet recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Jul 2026 --> Jul 2028

P2, N=40, Not yet recruiting, M.D. Anderson Cancer Center

P1/2, N=612, Recruiting, Regeneron Pharmaceuticals | N=326 --> 612 | Trial primary completion date: Jan 2027 --> Apr 2027

P1/2, N=690, Recruiting, Regeneron Pharmaceuticals | Trial completion date: Jul 2024 --> Jun 2026 | Trial primary completion date: Jul 2024 --> Jun 2026

Conclusion/Implications Ubamatamab +/- cemiplimab demonstrated acceptable safety and evidence of clinical activity in heavily pretreated OC. An ongoing randomised Phase 2 study is evaluating ubamatamab alone and with cemiplimab.

The impact of ubamatamab on QOL and physical functioning will be assessed. Current Trial Status: The study is currently recruiting patients to combination dose escalation, monotherapy dose expansion, and the randomized Phase 2 cohort.

No abstract available

MUC16 expression is a frequent feature in epithelioid sarcoma and may be identified in other INI-1-deficient malignancies. MUC16 is a possible therapeutic target and warrants further clinical trial development outside the ovarian cancer field.

Exclusion criteria include recent biologic therapy (7 days); approved conventional therapy (except biologics or immunotherapy) <3 weeks (wks) or investigational agents <4 wks prior to first study dose; and anti–PD-L1 therapy <5 T 1/2 prior to first study dose. Key exploratory endpoints are correlation between clinical efficacy endpoints and baseline protein expression levels of MUC16 and PD-L1. Results and Discussions NA Conclusion NA

Exclusion criteria include recent biologic therapy ( 7 days); approved conventional therapy (except biologics or immunotherapy) < 3 weeks (wks) or investigational agents < 4 wks prior to first study dose; and anti–PD-L1 therapy < 5 half-lives prior to first study dose . In expansion, primary endpoint is ORR by RECIST 1.1 for each combination; key secondary endpoints are TEAEs, serious AEs, deaths . Key exploratory endpoints are correlation between clinical efficacy endpoints and baseline protein expression levels of MUC16 and PD-L1.

No abstract available

This presentation will describe Regeneron’s bispecific platform and present preclinical data on REGN4018, a clinical-stage, T cell-engaging, bispecific-targeting Muc16 for solid tumor indications. In addition, status updates on Regeneron’s other clinical-stage bispecific antibodies (REGN1979, REGN5458, REGN5678) will be presented, as well as a discussion of new combinatorial approaches being taken to enhance bispecific anti-tumor efficacy.