Phase 1 Study of INV-1120 Alone and With Pembrolizumab in Adults With Advanced Solid Tumors to Assess Safety and Dosage

What this Trial Is About

Researchers are evaluating the safety, tolerability, and pharmacokinetics of INV-1120 alone and in combination with pembrolizumab in adult patients with advanced solid tumors. This phase 1, open-label, dose-escalation study aims to determine the maximum tolerated dose MTD, recommended phase 2 dose RP2D, and dose-limiting toxicities DLT of INV-1120 as a single agent or combined with pembrolizumab. The trial includes patients whose tumors have progressed after standard therapies or have no standard treatment options. In Phase 1a, approximately 36 patients will receive escalating oral doses of INV-1120 once daily until unacceptable toxicity or disease progression occurs. Up to 9 additional patients may be enrolled to confirm safety at the MTDRP2D. In Phase 1b, around 36-42 patients will receive escalating and de-escalating doses of oral INV-1120 combined with pembrolizumab, administered as 200 mg intravenously on Day 1 of each 3-week cycle, until toxicity or disease progression. Safety and tolerability of the combination will be confirmed in an expanded group of 12-15 patients. Participants will undergo safety evaluations during the first treatment cycle, including assessment of dose-limiting toxicities over 21 to 28 days depending on the phase. Researchers will monitor tumor response using imaging scans and assess pharmacokinetics through blood tests. Safety will be tracked using standard criteria for adverse events. The study period for primary outcome assessment is up to 12 months, during which patients will be closely observed for response, side effects, and drug levels to inform future dosing and treatment strategies.

An Open-Label Study of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors