Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With
To find the recommended dose of ulixertinib that can be given in combination with cetuximab and/or encorafenib to patients with unresectable/metastatic CRC and who have received EGFR or BRAF-directed therapy in the past.
| Condition(s) | Metastatic Colorectal Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | To find the recommended dose of ulixertinib that can be given in combination with cetuximab and/or encorafenib to patients with unresectable/metastatic CRC and who have received EGFR or BRAF-directed therapy in the past. |
| Who can participate | Inclusion Criteria: Patients must meet all of the inclusion criteria to be eligible: 1. Provision of signed Informed Consent prior to any screening procedures being performed. 1. Non-English speaking patients will be eligible for participation with involvement of the MD Anderson Language Assistance department in the informed consent process (per MD Anderson SOP 04\_Informed Consent Process). 2. Individuals lacking the ability, based on reasonable medical judgment, to understand and appreciate the nature and consequences of participation in this study will not be eligible for participation. 2. Age ≥ 18 years at the time of informed consent. 3. Histologically (or cytologically) confirmed diagnosis of adenocarcinoma of the colon or rectum, with clinical confirmation of unresectable and/or met |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | M.D. Anderson Cancer Center |
| Locations | Houston, Texas, United States |
| Start date | 2024-01-18 |
| NCT ID | NCT05985954 |
| Official listing | https://clinicaltrials.gov/study/NCT05985954 |