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Ubamatamab

Phase 2

Non Small Cell Lung Cancer | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: Aug 25, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Clinical trial landscape

Ubamatamab · 4 trials · 13 indications

Phase 2 2Phase 1 2
NCT07154290A Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)Non Small Cell Lung Cancer
RECRUITING300 Analytics
NCT06787612Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian CancerOvarian Cancer
RECRUITING297 Analytics
PHASE2RECRUITING
A Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Non Small Cell Lung CancerUnlock trial analytics
PHASE2RECRUITING
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective response as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Up to 5 years
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment
Up to 3 years
Safety run-in phase I : Safety and recommended dose for phase II trial during the Dose-limiting toxicities monitoring period
Up to 4 weeks of treatment

Incidence of Treatment emergent adverse events according to NCI CTCAE version 6.0 (Safety and Tolerability)

Efficacy phase II part
1 month after Cycle 3 Day 1 of the sixth patient included (each cycle is 21 days).

Objective response rate (ORR): Percentage of patients experiencing complete (CR) or partial response (PR) as the best overall radiological response after 3 cycles of ubamatamab in combination with carboplatin-paclitaxel-bevacizumab based on RECIST 1.1 criteria

Number of participants with Dose-limiting toxicity (DLTs) for ubamatamab monotherapy
From Cycle 1, Day 1 up to 35 days

Dose Escalation Phase

Number of participants with DLTs for ubamatamab with cemiplimab
From 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 monotherapy
Up to 2 years

Dose Escalation Phase

Number of participants with TEAEs (including imAEs) for ubamatamab with cemiplimab
Up to 2 years

Dose Escalation Phase

Number of participants with serious adverse events (SAEs) for ubamatamab monotherapy
Up to 2 years

Dose Escalation Phase

Number of participants with SAEs for ubamatamab with cemiplimab
Up to 2 years

Dose Escalation Phase

Number of deaths for ubamatamab monotherapy
Up to 2 years

Dose Escalation Phase

Number of deaths for ubamatamab with cemiplimab
Up 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 monotherapy
Up to 2 years

Dose Escalation Phase

Number of participants with laboratory abnormalities (grade 3 or higher per CTCAE) for ubamatamab with cemiplimab
Up to 2 years

Dose Escalation Phase

Concentration of ubamatamab in serum over time for ubamatamab monotherapy
Up to 2 years

Dose Escalation Phase

Concentration of ubamatamab in serum over time for ubamatamab with cemiplimab
Up to 2 years

Dose Escalation Phase

Objective response rate (ORR) defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for ubamatamab monotherapy
Up to 2 years

Dose Expansion Phase

ORR defined by RECIST 1.1 for ubamatamab with cemiplimab
Up to 2 years

Dose Expansion Phase

Secondary Endpoints

Occurrence of Treatment Emergent Adverse Events (TEAEs)
Up to 5 years
Severity of TEAEs
Up to 5 years
Occurrence of Treatment-Related Adverse Events (TRAEs)
Up to 5 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1AEXPERIMENTAL -
Arm 1BEXPERIMENTAL -
Arm 1CEXPERIMENTAL -
Arm 2AEXPERIMENTAL -
Arm 2BEXPERIMENTAL -
Arm 2CEXPERIMENTAL -
Arm A1EXPERIMENTAL -
Arm A2EXPERIMENTAL -
Arm BEXPERIMENTAL -
Arm CEXPERIMENTAL -
Arm DEXPERIMENTAL -
Arms E1/E2EXPERIMENTAL -
Carboplatin-paclitaxel-bevacizumab + ubamatamabEXPERIMENTALAll participants will receive 3 cycles of the combination carboplatin-paclitaxel-bevacizumab + ubamatamab. After the 3 cycles, they will undergo surgery if it is feasible. Subsequently, they will receive maintenance treatment: * ubamatamab + bevacizumab: for participants with BRCA wild-type and HRD negative tumors and for participants with a disease characterized by a BRCA mutation, or HRD positive status, and experiencing stable disease during the chemotherapy * Olaparib + bevacizumab (standard of care): for participants with a disease characterized by a BRCA mutation, or HRD-positive status, and experiencing complete or partial response during the chemotherapy.
MonotherapyEXPERIMENTALREGN4018 administration
Combination TherapyEXPERIMENTALREGN4018 and cemiplimab administration

Interventions

NameTypeDescription
UbamatamabDRUGAdministered per the protocol
MarlotamigDRUGAdministered per the protocol
SarilumabDRUGAdministered per the protocol
BevacizumabDRUGAdministered per the protocol
CemiplimabDRUGAdministered per the protocol
FianlimabDRUGAdministered per the protocol
PLDDRUGAdministered per the protocol
REGN10597DRUGAdministered per the protocol
ChemotherapyDRUGCarboplatin + Paclitaxel administered at each cycle of 21 days (in total 3 cycles).
GCSFDRUGAdministered at each cycle during the 3 first cycles of the drug combination (chemotherapy + bevacizumab + ubamatamab).
TocilizumabDRUGAdministered per the protocol
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Key Inclusion Criteria: 1. Has histologically or cytologically confirmed diagnosis of advanced (stage IIIB not amenable to definitive chemoradiotherapy or stage IIIC) or metastatic (stage IV) NSCLC 2. Has received appropriate first line standard of care treatment for advanced or metastatic NSCLC, a...

Countries:United StatesCanadaSouth KoreaTaiwanTurkey (Türkiye)FranceAustraliaBelgiumIsraelItalyNetherlandsSpainUnited Kingdom
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Competitive Landscape -Non-Small Cell Lung Cancer 387 trials (matched to "Non Small Cell Lung Cancer")

Recent Changes (Last 90 Days)

LOWAug 25, 2026NCT07154290lastUpdatePostDate: changed
LOWAug 25, 2026NCT07154290lastUpdatePostDate: changed
MEDIUMAug 14, 2026NCT07154290primaryCompletionDate: changed
MEDIUMAug 14, 2026NCT07154290primaryCompletionDate: changed
MEDIUMAug 14, 2026NCT07154290primaryCompletionDate: changed
MEDIUMAug 12, 2026NCT06787612Enrollment: 220 → 297
MEDIUMAug 12, 2026NCT06787612Enrollment: 220 → 297
LOWJul 22, 2026NCT03564340lastUpdatePostDate: changed
LOWJul 22, 2026NCT07154290lastUpdatePostDate: changed
LOWJul 22, 2026NCT03564340lastUpdatePostDate: changed
LOWJul 22, 2026NCT07154290lastUpdatePostDate: changed
LOWJul 9, 2026NCT06787612lastUpdatePostDate: changed
LOWJul 9, 2026NCT06787612lastUpdatePostDate: changed
LOWJul 8, 2026NCT07154290lastUpdatePostDate: changed
LOWJul 8, 2026NCT07154290lastUpdatePostDate: changed
LOWJun 23, 2026NCT06787612lastUpdatePostDate: changed
LOWJun 23, 2026NCT06787612lastUpdatePostDate: changed
LOWJun 16, 2026NCT07154290lastUpdatePostDate: changed
LOWJun 16, 2026NCT07154290lastUpdatePostDate: changed
LOWJun 16, 2026NCT07154290lastUpdatePostDate: changed

Frequently asked questions about Ubamatamab

What is Ubamatamab used for?

Ubamatamab is an investigational bispecific antibody being studied for the treatment of recurrent ovarian cancer, other MUC16-expressing cancers, and advanced or metastatic non-small cell lung cancer. It is also being evaluated in combination with other therapies for platinum-resistant ovarian cancer and as a first-line treatment for ovarian cancer.

What does Ubamatamab target?

Ubamatamab is a bispecific antibody that targets MUC16, a protein expressed on the surface of certain cancer cells. By binding to MUC16, it is designed to direct the immune system to attack and destroy cancer cells that express this protein.

Who is developing Ubamatamab?

Ubamatamab is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company. Regeneron is conducting multiple clinical trials to evaluate the safety and efficacy of Ubamatamab in various cancer indications.

What phase is Ubamatamab in?

Ubamatamab is currently in Phase 2 clinical development. It is being studied in Phase 2 trials for recurrent ovarian cancer and non-small cell lung cancer, with additional Phase 1 trials exploring its use in other settings. It is not yet approved by regulatory authorities.

What clinical trials is Ubamatamab in?

Ubamatamab is being evaluated in several clinical trials, including NCT03564340 (Phase 1, recurrent ovarian cancer and other MUC16+ cancers), NCT06787612 (Phase 2, platinum-resistant ovarian cancer), NCT07154290 (Phase 2, non-small cell lung cancer), and NCT07637851 (Phase 1, first-line ovarian cancer).

Is Ubamatamab the same as REGN4018?

Yes, Ubamatamab is also known as REGN4018. In clinical trials, it is sometimes referred to by this alternative name, particularly in earlier studies. Both names refer to the same investigational bispecific antibody being developed by Regeneron.