Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · November 3, 2026
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Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07912593). This is a study registration, not published results. Lead sponsor: Ensem Therapeutics. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 320 participants (ESTIMATED). Conditions: Metastatic Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC), Non-squamous, Non-Small Cell Lung Cancer, Endometrial Adenocarcinoma, Ovarian Adenocarcinoma, Primary Peritoneal Carcinoma. Interventions: DRUG: ETX-929 dose escalation; DRUG: ETX-929 dose escalation in combination with cetuximab. Primary outcome measures: Evaluate Safety and Tolerability of ETX-929 monotherapy in Part A and ETX-929 plus cetuximab combination therapy in Part B , First Cycle (21 days in Part A and 28 days in Part B); Evaluate Safety and Tolerability of ETX-929 monotherapy in Part A and ETX-929 plus cetuximab combination therapy in Part B , Average of 6 months; Select the Recommended Phase 2 Dose(s) (RP2D) , Average of 6 months; Evaluate efficacy of ETX-929 monotherapy and ETX-929 in combination with cetuximab at the RP2D(s) in Part B and Part D , Average of 6 months. Brief summary: This is a Phase 1/2, open-label, multi-center study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of ETX-929 in participants with advanced solid tumors harboring a Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation.