NCT03589651

INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors

A Phase 1b Study of INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Incyte Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety, preliminary evidence of clinical activity, and recommended Phase 2 dose (RP2D) of INCMGA00012 in combination with other agents that may improve the therapeutic efficacy of anti-PD-1 monotherapy.

Conditions

• Unresectable or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	Retifanlimab	Part 1: INCMGA00012 at the protocol-defined starting dose administered intravenously every 4 weeks, with dose escalation to determine the maximum tolerated dose. Part 2: INCMGA00012 at the recommended dose from Part 1.
DRUG	Epacadostat	Part 1: Epacadostat at the protocol-defined starting dose administered orally twice daily, with dose escalation to determine the maximum tolerated dose. Part 2: Epacadostat at the recommended dose from Part 1.
DRUG	INCB050465	Part 1: INCB050465 at the protocol-defined starting dose administered orally once daily, with dose escalation to determine the maximum tolerated dose. Part 2: INCB050465 at the recommended dose from Part 1.

Timeline

• Start date: 2018-08-17
• Primary completion: 2022-11-21
• Completion: 2022-11-21
• First posted: 2018-07-18
• Last updated: 2023-02-21

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study