Genmab and Incyte said Oct. 24 they plan to assess a three-drug regimen in a Phase 1/2 study for patients with KRAS G12D-mutated metastatic colorectal cancer who are receiving first-line treatment.
The combination will bring together petosemtamab, Genmab’s investigational antibody targeting EGFR and LGR5, and Incyte’s investigational KRAS G12D inhibitor INCB161734, alongside standard-of-care chemotherapy. Genmab describes petosemtamab as an IgG1 bispecific antibody. The announcement reports no safety or efficacy findings for the combination.
Genmab will conduct the study. Incyte will co-fund the work and provide INCB161734 for clinical use. The companies did not disclose the amount of Incyte’s contribution, a start date or a planned enrollment target.
The companies said they want to explore whether medicines with different, potentially complementary mechanisms, alongside chemotherapy, could offer a treatment option. Judith Klimovsky, Genmab’s executive vice president and chief development officer, said the collaboration supports the company’s broader strategy for developing petosemtamab across treatment settings.
Genmab says petosemtamab is also being studied in head and neck squamous cell carcinoma and other solid tumors, including colorectal cancer. Separately, two Phase 3 trials are evaluating the antibody with chemotherapy for first- and second-line treatment of metastatic colorectal cancer with RAS/BRAF wild-type tumors.
Genmab’s release estimates that KRAS mutations occur in about 40% of colorectal cancers and that the G12D variant occurs in about 15% of cases. It identifies G12D as the most common KRAS mutation.
The announcement gives no recruitment start, chemotherapy regimen, dose plan, endpoints or expected readout for the new study. It also does not provide a trial identifier. A ClinicalTrials.gov entry, NCT06179160, identifies a separate open-label trial in its first phase, testing INCB161734 in patients with KRAS G12D-positive solid tumors.
