Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1)

Summary

GSK3359609 is an anti-Inducible T cell Co-Stimulator (ICOS) receptor agonist antibody intended for the treatment of cancers of different histology. This is a first-time-in-human (FTIH), open-label, multicenter study designed to investigate the safety, pharmacology, and preliminary antitumor activity in participants with selected, advanced or recurrent solid tumors with the aim to establish recommended dose(s) of GSK3359609 for further exploration as monotherapy and in combination with pembrolizumab or chemotherapy regimens. The study is comprised of two primary parts, each composed of two phases: Part 1: GSK3359609 monotherapy with Part 1A as dose escalation phase and Part 1B as cohort expansion phase; Part 2: GSK3359609 combination therapy with Part 2A pembrolizumab or GSK3174998 or chemotherapy or pembrolizumab plus chemotherapy or dostarlimab plus cobolimab or Bintrafusp alfa combination dose escalation phase and Part 2B expansion phase with pembrolizumab. The primary objective of the study is to determine the safety, tolerability, maximum tolerated dose or the maximum administered dose of GSK3359609 alone or in combination.

Timeline

Start

2016-06-23

Primary completion

2023-07-05

Completion

2023-07-05

Publications

• Background Turner DC, Wada R, Zhou H, Wang X, de Greef R, Valiathan C, Zhang L, Zhang N, Kuchimanchi M, Chen TT, Ballas M, Visser SAG. Model-based meta-analysis of non-small cell lung cancer with standard of care PD-1 inhibitors and chemotherapy for early development decision making. CPT Pharmacometrics Syst Pharmacol. 2023 Nov;12(11):1751-1763. doi: 10.1002/psp4.12917. Epub 2023 Jan 31.
• Yadavilli S, Waight JD, Brett S, Bi M, Zhang T, Liu YB, Ellis C, Turner DC, Hahn A, Shi H, Seestaller-Wehr L, Jing J, Xie Q, Shaik JS, Ji X, Gagnon R, Fieles W, Hook L, Grant S, Hopley S, DeYoung MP, Blackwell C, Chisamore M, Biddlecombe R, Figueroa DJ, Hopson CB, Srinivasan R, Smothers J, Maio M, Rischin D, Olive D, Paul E, Mayes PA, Hoos A, Ballas M. Activating Inducible T-cell Costimulator Yields Antitumor Activity Alone and in Combination with Anti-PD-1 Checkpoint Blockade. Cancer Res Commun. 2023 Aug 16;3(8):1564-1579. doi: 10.1158/2767-9764.CRC-22-0293. eCollection 2023 Aug.

Drugs

Indications