NCT04198766

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

An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Multicohort, Phase 1/2 Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 296 (actual)
• Sponsor: Inhibrx Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor
• Non-Small Cell Lung Cancer
• Head and Neck Cancer
• Melanoma
• Gastric Cancer
• Renal Cell Carcinoma
• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	INBRX-106 - Hexavalent OX40 agonist antibody	The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).
DRUG	pembrolizumab 200 mg	pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.
DRUG	pembrolizumab 400 mg	pembrolizumab 400 mg by IV infusion given on Day 1 of alternating 21-day cycles (every 6 weeks)
DRUG	Carboplatin AUC-5	carboplatin AUC-5 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4
DRUG	Carboplatin AUC-6	carboplatin AUC-6 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4
DRUG	Pemetrexed 500 mg/m2	pemetrexed 500 mg/m2 by IV infusion given on Day 1 of each 21-Day cycle for up to 35 cycles
DRUG	Cisplatin 75mg/m2	cisplatin 75mg/m2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4
DRUG	Paclitaxel 200mg/m2	paclitaxel 200mg/m2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4
DRUG	Nab paclitaxel 100mg/m2	Nab paclitaxel 100mg/m2 by intravenous (IV) infusion, given on Days 1, 8 and 15 of each 21-day cycle of cycles 1-4

Timeline

• Start date: 2019-12-10
• Primary completion: 2026-10-30
• Completion: 2027-05-12
• First posted: 2019-12-13
• Last updated: 2025-12-18

Locations

42 sites across 4 countries: United States, Singapore, South Korea, Taiwan

Regulatory

• FDA-regulated drug study