NCT03809624

Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer

An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Phase 1 / 2 Study of INBRX-105 and INBRX-105 in Combination With Pembrolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Inhibrx Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human, open-label, nonrandomized, four-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX-105 and INBRX-105 in combination with Pembrolizumab. INBRX-105, a next generation bispecific antibody, targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor. INBRX-105 provides localized conditional T-cell co-stimulation through 4-1BB agonism.

Conditions

• Metastatic Solid Tumors
• Non-small Cell Lung Cancer
• Melanoma
• Head and Neck Squamous Cell Carcinoma
• Gastric Adenocarcinoma
• Renal Cell Carcinoma
• Esophageal Adenocarcinoma
• Nasopharyngeal Carcinoma
• Oropharyngeal Carcinoma

Interventions

Type	Name	Description
DRUG	INBRX-105 - PDL1x41BB antibody	The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.
DRUG	Pembrolizumab	Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.

Timeline

• Start date: 2019-01-30
• Primary completion: 2024-10-03
• Completion: 2024-10-03
• First posted: 2019-01-18
• Last updated: 2024-10-23

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study