Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer (LiGeR-CRC1)

Conditions

• Left-sided Colorectal Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Petosemtamab — DRUG
  Intravenous infusion
• Cetuximab — DRUG
  Intravenous infusion
• FOLFIRI — DRUG
  Fluorouracil + leucovorin (calcium folinate) + irinotecan via intravenous infusion.
• mFOLFOX6 — DRUG
  Fluorouracil + leucovorin (calcium folinate) + oxaliplatin via intravenous infusion.

Study Details

The purpose of this trial is to evaluate how well petosemtamab in combination with chemotherapy works against colorectal cancer located on the left side of the colon that cannot be safely removed by surgery or has spread to other parts of the body. Participants will receive either petosemtamab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI) or standard-of-care cetuximab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI). No participants will be given placebo. The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open. Participants will be asked to attend 2 visits at the study clinic for each cycle (duration of cycle is 4 weeks). During visits, there will be various tests (such as blood draws) and procedures (such as imaging) to monitor whether the study treatment is safe and effective. The overall study duration (including screening, treatment, and follow-up) will be different for every participant.

Key Dates

First listed

Jul 14, 2026

Start date

Aug 11, 2026

Status verified

Aug 2026

Primary completion

Jul 31, 2029

Completion

Sep 30, 2031

Study Design

Enrollment

960 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Petosemtamab + IC Chemotherapy
  Participants will receive petosemtamab and IC chemotherapy (mFOLFOX6 or FOLFIRI).
• Active Comparator: Cetuximab + IC Chemotherapy
  Participants will receive cetuximab + IC chemotherapy (mFOLFOX6 or FOLFIRI).

Primary Outcome Measure

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 35 months ]

Central Contacts

• Genmab Trial Information
  +4570202728
  [email protected]

Locations (1)

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