Phase 2
Completed N=29
MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01)
Source: ClinicalTrials.gov NCT04495621 ↗Enrolled (actual)
29
Serious AEs
55.2%
Results posted
May 2025
Primary outcomePrimary: Phase 1b: Recommended Phase 2 Dose (RP2D) of MEN1611 in Combination With Cetuximab — 48 mg
Summary
Open-label, dose-confirmation and cohort expansion, multicenter, Phase Ib/II study to assess the anti-tumor activity and safety of MEN1611 in combination with cetuximab for the treatment of participants with phosphatidylinositol 3-kinase, catalytic, alpha polypeptide gene (PIK3CA)-mutated metastatic colorectal cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1b: Recommended Phase 2 Dose (RP2D) of MEN1611 in Combination With Cetuximab |
48 | — |
| PRIMARY Best Overall Response Rate (ORR) of MEN1611 in Combination With Cetuximab |
0.0; 7.1; 40.0; 7.1; 40.0; 57.1 | — |
| PRIMARY Phase 1b: Number of Participants With DLTs for MEN1611 |
— | — |
| SECONDARY Plasma Concentration of MEN1611 in Combination With Cetuximab |
173.37; 241.2 | — |
| SECONDARY Disease Control Rate (DCR) of MEN1611 in Combination With Cetuximab |
80; 71.4 | — |
| SECONDARY Duration of Response (DOR) of MEN1611 in Combination With Cetuximab |
85; 169 | — |
| SECONDARY Progression-free Survival (PFS) of MEN1611 in Combination With Cetuximab |
121; 162 | — |
| SECONDARY Overall Survival (OS) of MEN1611 in Combination With Cetuximab |
471; 308 | — |
Eligibility Criteria
Main Inclusion Criteria:
- Histological documentation of adenocarcinoma of the colon or rectum.
- Progression or recurrence following prior irinotecan, oxaliplatin, 5-fluorouracil (5-FU) and anti-epidermal growth factor receptor (EGFR) containing regimens for metastatic disease.
- Best response according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria to the last anti-EGFR containing regimen of partial response or stable disease for at least 4 months.
- Measurable disease according to RECIST criteria.
- N-K-RAS (exons 2, 3 and 4) and BRAF wild-type and PIK3CA mutated.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
Main Exclusion Criteria:
- Previous treatment with PI3K inhibitor.
- Brain metastases, unless treated >4 weeks before screening visit and only if clinically stable and not receiving corticosteroids.
- National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 Grade ≥2 diarrhea.
- History of significant, uncontrolled or active cardiovascular disease.
- Known active or uncontrolled pulmonary dysfunction.
- Uncontrolled diabetes mellitus (glycated hemoglobin >7%) and fasting plasma glucose >126 milligrams/deciliter.
- Known history of human immunodeficiency virus infection or active infection with hepatitis C virus or hepatitis B virus.
- Concurrent chronic immunosuppressive treatment either with steroids or other immunosuppressive agents.
Data sourced from ClinicalTrials.gov (NCT04495621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.