Clinical trial · Interventional
MEN1611 With Cetuximab in Metastatic Colorectal Cancer (C-PRECISE-01)
Open-label, Multicentre, Phase Ib/II Study of MEN1611, a PI3K Inhibitor, and Cetuximab in Patients With PIK3CA Mutated Metastatic Colorectal Cancer Failing Irinotecan, Oxaliplatin, 5-FU and Anti-EGFR Containing Regimens
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MEN1611
- description
- MEN1611 + Cetuximab
- interventionNames
- Drug: MEN1611
- Drug: Cetuximab
Primary outcomes (3)
- measure
- Phase 1b: Recommended Phase 2 Dose (RP2D) of MEN1611 in Combination With Cetuximab
- timeFrame
- Day 1 through Day 28 of Cycle 1 (28 days/cycle)
- description
- RP2D was defined as the highest dose level in milligrams (mg) at which no more than 1 participant during the dose confirmation phase (Phase 1b) experienced a dose-limiting toxicity (DLT) during the DLT assessment window (28 days), or the maximum dose judged to be tolerable by the data safety committee.
- measure
- Best Overall Response Rate (ORR) of MEN1611 in Combination With Cetuximab
- timeFrame
- Up to 37 Months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available