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REGN5668

Phase 1

Ovarian Cancer | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: Nov 21, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment612
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04590326A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or UbamatamabPHASE1 RECRUITING 612 — — Dec 8, 2020Nov 30, 2027Nov 21, 202524 United States, Belgium +2
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Study Endpoints
Primary Endpoints
Incidence of Dose Limiting Toxicities (DLT)
42 days

Dose escalation phase, Module 1

Incidence of DLTs
21 days post combination administration

Dose escalation phase, Module 2

Incidence of Treatment-Emergent Adverse Events (TEAEs)
Through study completion, up to 5 years

Primary: Dose escalation phase Secondary: Dose expansion phase

Incidence of Serious Adverse Events (SAEs)
Through study completion, up to 5 years

Primary: Dose escalation phase Secondary: Dose expansion phase

Incidence of deaths
Through study completion, up to 5 years

Primary: Dose escalation phase Secondary: Dose expansion phase

Incidence of laboratory abnormalities (Grade 3 or higher per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE] version 5.0 [v5.0])
Through study completion, up to 5 years

Primary: Dose escalation phase Secondary: Dose expansion phase

Concentrations of REGN5668 in serum when dosed alone and in combination with cemiplimab or ubamatamab
Through study completion, up to 5 years

Primary: Dose escalation phase

Objective Response Rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (Eisenhauer, 2009) of REGN5668 in combination with cemiplimab, cemiplimab + fianlimab, or ubamatamab (separately by cohort and combination)
Through study completion, up to 5 years

Primary: Dose expansion phase

Secondary Endpoints
ORR based on RECIST 1.1
Through study completion, up to 5 years
Best Overall Response (BOR) based on RECIST 1.1
Through study completion, up to 5 years
Duration Of Response (DOR) based on RECIST 1.1
Through study completion, up to 5 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Module 1EXPERIMENTALREGN5668 in combination with cemiplimab, or cemiplimab + fianlimab
Module 2EXPERIMENTALREGN5668 and ubamatamab
Interventions
NameTypeDescription
REGN5668DRUGAdminister per the protocol
CemiplimabDRUGAdminister per the protocol
UbamatamabDRUGAdminister per the protocol
SarilumabDRUGAdminister per the protocol
Cemiplimab + Fianlimab [Fixed Dose Combination (FDC)]DRUGAdminister per the protocol
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites24

Key Inclusion Criteria: 1. Ovarian Cancer Cohorts Only: Has histologically or cytologically confirmed diagnosis of advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer that has received at least 1 line of platinum-based systemic therapy as defined...

Countries:United StatesBelgiumFranceSpain
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Competitive Landscape -Ovarian Cancer 180 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel, Sacituzumab tirumotecan
AstraZeneca PLCAZN19PHASE3Olaparib, Bevacizumab, Durvalumab, Carboplatin+Paclitaxel, AZD5335
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab, Mirvetuximab soravtansine, Carboplatin, Mirvetuximab Soravtansine
GSK plc Sponsored ADRGSK4PHASE3Niraparib, Dostarlimab, Mocertatug rezetecan, Paclitaxel, Pegylated liposomal doxorubicin
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab, BMS-986340, BMS-936558-01, Docetaxel
Pfizer Inc.PFE5PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel /m^2, Relacorilant once daily, Bevacizumab /kg
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib, azenosertib, Carboplatin, Pegylated liposomal doxorubicin, Paclitaxel
Incyte CorporationINCY2PHASE3INCB123667
Genelux Corp.GNLX1PHASE3olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane or pegylated liposomal doxorubicin, Bevacizumab
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Novartis AG Sponsored ADRNVS4PHASE2Dabrafenib, Trametinib, KFA115, pembrolizumab, Tulmimetostat
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib, BG-68501, Fulvestrant, BGB-43395
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Exelixis, Inc.EXEL2PHASE2Cabozantinib, cabozantinib, atezolizumab
Xencor, Inc.XNCR3PHASE2vudalimab, XmAb541, XmAb808
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04590326primaryCompletionDate: changed
LOWMay 24, 2026NCT04590326studyFirstPostDate: changed