Spots Global Cancer Trial Database for An Open-Label Study of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Official Title: A Phase 1a/1b, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Evidence of Antitumor Activity of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors

Study ID: NCT04443088

Conditions

Solid Tumor, Unspecified, Adult

Tumor, Solid

Interventions

INV-1120

Pembrolizumab

Study Description

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.

Detailed Description: Phase 1a: it is anticipated that approximately 36 patients will be enrolled in the dose escalation phase as a single agent of the study. Additionally, up to 9 additional patients may be enrolled to confirm the safety of patients treated at the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D). Phase 1b: approximately 36-42 patients will be enrolled in the dose escalation and de-escalation phases in the combination with pembrolizumab. One or more combination dose levels that could represent the combination RP2D will be expanded to a total of 12-15 patients to confirm safety and tolerability of the combination.