NCT04443088

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Shenzhen Ionova Life Sciences Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Solid Tumor, Adult
• Cancer Metastatic
• Solid Carcinoma
• Solid Tumor, Unspecified, Adult
• Tumor, Solid

Interventions

Type	Name	Description
DRUG	INV-1120	INV-1120 is an investigational selective and potent small molecule indicated for the treatment of solid malignancies including, but not limited to colorectal, breast, pancreatic, lung and liver cancers.
COMBINATION_PRODUCT	Pembrolizumab	Pembrolizumab will be administered as a dose of 200 mg on Day 1 of each 3-week treatment cycle.

Timeline

• Start date: 2020-06-26
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2020-06-23
• Last updated: 2026-03-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study