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Petosemtamab

Phase 3

Colorectal Cancer | Small molecule | Other |Genmab A/S|Last Updated: Aug 20, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment600

FDA Designations

No designations recorded

Clinical trial landscape

Petosemtamab · 2 trials · 2 indications

Phase 3 2
NCT07775287Study of Petosemtamab Plus Chemotherapy Versus Cetuximab or Bevacizumab Plus Chemotherapy in RAS and BRAF Wild Type, Recurrent, Unresectable or Metastatic Colorectal Cancer (LiGeR-CRC2)Colorectal Cancer
NOT YET_RECRUITING600 Analytics
NCT07702032Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal CancerLeft-sided Colorectal Cancer
NOT YET_RECRUITING960 Analytics
PHASE3NOT YET_RECRUITING
Study of Petosemtamab Plus Chemotherapy Versus Cetuximab or Bevacizumab Plus Chemotherapy in RAS and BRAF Wild Type, Recurrent, Unresectable or Metastatic Colorectal Cancer (LiGeR-CRC2)
Colorectal CancerUnlock trial analytics
PHASE3NOT YET_RECRUITING
Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer
Left-sided Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Central Review (BICR)
Up to approximately 2.5 years
Objective Response Rate (ORR) per RECIST v1.1 as Assessed by BICR
Up to approximately 2.5 years

Secondary Endpoints

Overall Survival (OS)
Up to approximately 3.5 years
Duration of Response (DOR) per RECIST v1.1 as Assessed by BICR
Up to approximately 3.5 years
Disease Control Rate (DCR) per RECIST v1.1 as Assessed by BICR
Up to approximately 3.5 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm A: Petosemtamab + IC Chemotherapy (FOLFIRI or mFOLFOX6)EXPERIMENTALParticipants will receive petosemtamab 1500 milligrams (mg) once every 2 weeks (Q2W) + IC chemotherapy (FOLFIRI or mFOLFOX6) Q2W.
Arm B: IC Cetuximab or Bevacizumab + IC Chemotherapy (FOLFIRI or mFOLFOX6)ACTIVE_COMPARATORParticipants will receive IC cetuximab 500 milligrams per meter squared (mg/m\^2) or bevacizumab 5 milligrams per kilogram (mg/kg) Q2W + IC chemotherapy (FOLFIRI or mFOLFOX6) Q2W.
Petosemtamab + IC ChemotherapyEXPERIMENTALParticipants will receive petosemtamab and IC chemotherapy (mFOLFOX6 or FOLFIRI).
Cetuximab + IC ChemotherapyACTIVE_COMPARATORParticipants will receive cetuximab + IC chemotherapy (mFOLFOX6 or FOLFIRI).

Interventions

NameTypeDescription
PetosemtamabDRUGIntravenous (IV) infusion.
CetuximabDRUGIV infusion.
BevacizumabDRUGIV infusion.
5-FUDRUGIV infusion.
Leucovorin (Calcium Folinate)DRUGIV infusion.
OxaliplatinDRUGIV infusion.
IrinotecanDRUGIV infusion.
FOLFIRIDRUGFluorouracil + leucovorin (calcium folinate) + irinotecan via intravenous infusion.
mFOLFOX6DRUGFluorouracil + leucovorin (calcium folinate) + oxaliplatin via intravenous infusion.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Key Inclusion Criteria: * Histologically or cytologically confirmed colorectal adenocarcinoma that is recurrent, unresectable or metastatic. * Must have documented KRAS and NRAS wt CRC, as determined by medical record of results from local testing or as assessed by central testing. Next-generation ...

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Frequently asked questions about Petosemtamab

What is Petosemtamab used for?

Petosemtamab is an investigational antibody being studied for the treatment of colorectal cancer, specifically left-sided colorectal cancer. It is being evaluated in combination with chemotherapy for patients with RAS and BRAF wild-type, unresectable or metastatic disease. The drug is currently in Phase 3 clinical development and is not yet approved.

What does Petosemtamab target?

Petosemtamab is a monoclonal antibody, as indicated by its -mab suffix. Its specific molecular target is not disclosed in the available information. The drug is being studied in biomarker-selected patient populations with RAS and BRAF wild-type colorectal cancer, suggesting it may target a pathway relevant to these tumors.

Who is developing Petosemtamab?

Petosemtamab is being developed by Genmab A/S, a biopharmaceutical company listed on the Nasdaq under the ticker symbol GMAB. The company is conducting Phase 3 clinical trials to evaluate the drug's efficacy and safety in patients with colorectal cancer.

What phase is Petosemtamab in?

Petosemtamab is currently in Phase 3 clinical development. It is an investigational drug and has not received FDA approval. Two Phase 3 trials are planned but have not yet begun recruiting participants, indicating the drug is still in the clinical trial stage.

What clinical trials is Petosemtamab in?

Petosemtamab is involved in two Phase 3 clinical trials. The first, NCT07702032, compares petosemtamab plus chemotherapy to cetuximab plus chemotherapy in left-sided colorectal cancer. The second, NCT07775287, compares petosemtamab plus chemotherapy to cetuximab or bevacizumab plus chemotherapy in colorectal cancer. Both trials are not yet recruiting.

Is Petosemtamab the same as other drugs?

Petosemtamab is a distinct investigational drug and is not known to be the same as any other approved medication. It is being studied as a potential treatment for colorectal cancer, and its unique mechanism and target differentiate it from existing therapies like cetuximab and bevacizumab, which are used as comparators in its clinical trials.