Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Evixapodlin (Formerly GS-4224) in Participants With Advanced Solid Tumors

Phase 1 Terminated 18 enrolled Gilead Sciences

Non-randomizedSequentialOpen-labelTreatment

Summary

The primary objectives of this study are to characterize the safety and tolerability of evixapodlin (formerly GS-4224) and to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of evixapodlin in participants with advanced solid tumors.

Timeline

Start: 2019-08-26
Primary completion: 2021-03-30
Completion: 2021-03-30

Outcome

Outcome not reported

Stopped: “Gilead decision to terminate”

Publications

Odegard JM, Othman AA, Lin KW, Wang AY, Nazareno J, Yoon OK, Ling J, Lad L, Dunbar PR, Thai D, Ang E, Waldron N, Deva S. Oral PD-L1 inhibitor GS-4224 selectively engages PD-L1 high cells and elicits pharmacodynamic responses in patients with advanced solid tumors. J Immunother Cancer. 2024 Apr 11;12(4):e008547. doi: 10.1136/jitc-2023-008547.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Evixapodlin	Small molecule	400 mg	Oral
Subject	Evixapodlin	Small molecule	700 mg	Oral
Subject	Evixapodlin	Small molecule	1000 mg	Oral
Subject	Evixapodlin	Small molecule	1500 mg	Oral