An Open-Label Study of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
Phase 1, open-label dose-escalation study to determine the MTD of INV-1120 and RP2D, and to assess the DLT of INV-1120 as a single agent or in the combination with pembrolizumab. The safety, tolerability, and PK of INV-1120 as a single agent or in the combination with pembrolizumab will be assessed in adult patients with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent, according to local guidelines, signed and dated by the patient prior to the performance of any study-specific procedures, sampling, or analyses; 2. Patient must be ≥18 years-of-age at the time of signature of the informed consent form (ICF); 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1; 4. Patients with histologically or cytologically confirmed advanced solid tumors which have progressed on or following standard therapy or for which no standard therapy exists; 5. Patients with life expectancy ≥3 months; 6. Patients with at least one measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI), according to RECIST v1.1. Tumor lesions that have been irradiated ≥4 weeks before the start of treatment, and have subsequently had documented progression, may be chosen as target lesions in the absence of measurable lesions that have not been irradiated; 7. Patients whose laboratory data at s