A Study of ARRY-382 in Combination With Pembrolizumab for the Treatment of Patients With Advanced Solid Tumors

Phase 1/2 Terminated 82 enrolled Pfizer

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an open-label, multicenter Phase 1b/2 study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ARRY-382 in combination with pembrolizumab in adult patients with selected advanced solid tumors (Part A/Phase 1b); and to estimate the efficacy of the combination in three separate cohorts: 1) patients with advanced solid tumors that have progressed on prior PD-1/PD-L1inhibitors, 2) patients with platinum-resistant ovarian cancer and 3) patients with pancreatic ductal adenocarcinoma (Phase 2).

Timeline

Start: 2016-09-01
Primary completion: 2019-09-17
Completion: 2019-10-24

Outcome

Met primary endpoint

Stopped: “Study was halted prematurely due to insufficient efficacy. Not due to safety reasons.”

paper Primary endpoints of dose-limiting toxicities (DLT; Phase 1b) and objective response rate (Phase 2) were met. PMID 35302585 ↗

Publications

Johnson M, Dudek AZ, Sukari A, Call J, Kunk PR, Lewis K, Gainor JF, Sarantopoulos J, Lee P, Golden A, Harney A, Rothenberg SM, Zhang Y, Goldman JW. ARRY-382 in Combination with Pembrolizumab in Patients with Advanced Solid Tumors: Results from a Phase 1b/2 Study. Clin Cancer Res. 2022 Jun 13;28(12):2517-2526. doi: 10.1158/1078-0432.CCR-21-3009.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ARRY-382	Small molecule	200 mg	Oral
Subject	ARRY-382	Small molecule	300 mg	Oral
Subject	ARRY-382	Small molecule	400 mg	Oral
Subject	Pembrolizumab	Monoclonal antibody	2 mg/kg	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous