Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)

NCT04198766 ↗

Phase 1/2 Active not recruiting 296 enrolled Inhibrx Biosciences, Inc Merck Sharp & Dohme LLC · collab

RandomizedSequentialOpen-labelTreatment

Summary

This is a Phase 1/2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp \& Dohme LLC, a subsidiary of Merck \& Co., Inc., Rahway, NJ, USA.

Timeline

Start: 2019-12-10
Primary completion: 2026-10-30
Completion: 2027-05-12

Publications

Holay N, Yadav R, Ahn SJ, Kasiewicz MJ, Polovina A, Rolig AS, Staebler T, Becklund B, Simons ND, Koguchi Y, Eckelman BP, de Durana YD, Redmond WL. INBRX-106: a hexavalent OX40 agonist that drives superior antitumor responses via optimized receptor clustering. J Immunother Cancer. 2025 May 21;13(5):e011524. doi: 10.1136/jitc-2025-011524.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	INBRX-106	Unknown	0.1 mg/kg	—
Subject	INBRX-106	Unknown	0.3 mg/kg	—
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Subject	Pembrolizumab	Monoclonal antibody	400 mg	Intravenous
Background	Carboplatin	Small molecule	5 unknown	Intravenous
Background	Carboplatin	Small molecule	6 unknown	Intravenous
Background	Cisplatin	Other / unclassified	75 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	100 mg/m2	Intravenous
Background	Paclitaxel	Small molecule	200 mg/m2	Intravenous
Background	Pemetrexed	Small molecule	500 mg/m2	Intravenous

Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)

Summary

Timeline

Publications

Drugs

Indications