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DRUG:

REGN5668

i
Other names: REGN5668, R5668, R 5668, REGN 5668, R-5668, REGN-5668
Associations
Trials
Company:
Regeneron
Drug class:
CD28 agonist, MUC16 inhibitor
Associations
Trials
6ms
R5668-ONC-1938: A Trial to Find Out How Safe REGN5668 is and How Well it Works When Given With Either Cemiplimab or REGN4018 (clinicaltrials.gov)
P1/2, N=612, Recruiting, Regeneron Pharmaceuticals | N=326 --> 612 | Trial primary completion date: Jan 2027 --> Apr 2027
Enrollment change • Trial primary completion date • Combination therapy
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Libtayo (cemiplimab-rwlc) • ubamatamab (REGN4018) • Kevzara (sarilumab) • REGN5668
over1year
Clinical • P1/2 data
|
MUC16 (Mucin 16, Cell Surface Associated)
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Libtayo (cemiplimab-rwlc) • ubamatamab (REGN4018) • REGN5668
2years
Phase I/II, multicenter, open-label study of REGN5668 (R5668; mucin [MUC]16 x CD28 bispecific antibody [bsAb]) with cemiplimab or REGN4018 (R4018; MUC16 x CD3 bsAb) in recurrent ovarian cancer (rOVCA) (EACR 2022)
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
Clinical • P1/2 data • PD(L)-1 Biomarker • IO biomarker
|
MUC16 (Mucin 16, Cell Surface Associated)
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MUC16 expression
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Avastin (bevacizumab) • Libtayo (cemiplimab-rwlc) • ubamatamab (REGN4018) • REGN5668
over3years
[VIRTUAL] A phase I/II, multicenter, open-label study of REGN5668 (mucin [MUC]16 x CD28 bispecific antibody [bsAb]) with cemiplimab (programmed death [PD]-1 Ab) or REGN4018 (MUC16 x CD3 bsAb) in recurrent ovarian cancer (rOVCA). (ASCO 2021)
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.
Clinical • P1/2 data • PD(L)-1 Biomarker • IO biomarker
|
MUC16 (Mucin 16, Cell Surface Associated) • PD-L2 (Programmed Cell Death 1 Ligand 2)
|
MUC16 expression
|
Avastin (bevacizumab) • Libtayo (cemiplimab-rwlc) • ubamatamab (REGN4018) • REGN5668