A Study of NDI 1150-101 in Patients With Solid Tumors

Phase 1/2 Active not recruiting 106 enrolled Nimbus Saturn, Inc.

Non-randomizedSequentialOpen-labelTreatment

Summary

This study is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) and to investigate the safety, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of NDI-101150 given as monotherapy or in combination with pembrolizumab in adult patients with advanced solid tumors.

Timeline

Start: 2021-11-05
Primary completion: 2025-02
Completion: 2025-05

Publications

Braun DA, Noel MS, Moy RH, Demel K, Gutierrez M, Sharma S, Hussain A, Gadgeel S, Peguero J, Choueiri TK, Emamekhoo H, Van Tine B, Balaraman R, Elliott G, Nath S, Daigle SR, Kumar P, Scheuber A, Sommerhalder D. HPK1 inhibitor NDI-101150 as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors: Phase 1/2 trial results. Cell Rep Med. 2026 May 19;7(5):102789. doi: 10.1016/j.xcrm.2026.102789. Epub 2026 May 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NDI-101150	Unknown	100 mg	Oral
Subject	NDI-101150	Unknown	150 mg	Oral
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous

A Study of NDI 1150-101 in Patients With Solid Tumors

Summary

Timeline

Publications

Drugs

Indications