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NCT04198766 · ClinicalTrials.gov record · last posted 2026-07-29

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

StatusRecruiting
PhasePhase 1/2
Started2019-12-10
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
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.

Protocol amendment history 6 changes detected by DataLookout

2026-07-30
Enrollment reopened
2026-07-30
Primary endpoint(s) modified
WasAntitumor activity of INBRX-106 in combination with pembrolizumab in expansion cohorts, Frequency and severity of adverse events of INBRX-106 in combination with pembrolizumab and chemotherapy in adults with locally advanced or metastatic NSCLC, Frequency of adverse events of INBRX-106 as single agent and in combination with pembrolizumab, MTD and/or RP2D of INBRX-106 as single agent and in combination with pembrolizumab, Severity of adverse events of INBRX-106 as single agent and in combination with pembrolizumab
NowAntitumor activity of INBRX-106 in combination with pembrolizumab in expansion cohorts, Frequency and severity of adverse events of INBRX-106 in combination with pembrolizumab and chemotherapy in adults with locally advanced or metastatic NSCLC or resectable Stage II, IIIA or IIIB (T3-4N2) NSCLC, Frequency of adverse events of INBRX-106 as single agent and in combination with pembrolizumab, MTD and/or RP2D of INBRX-106 as single agent and in combination with pembrolizumab, Severity of adverse events of INBRX-106 as single agent and in combination with pembrolizumab, To assess the antitumor activity of INBRX-106 in combination with pembrolizumab and platinum doublet chemotherapy as neoadjuvant/adjuvant therapy in adult subjects with NSCLC. (Cohort F8)
2026-07-30
Enrollment increased: 296 → 340 participants
2026-07-30
Trial arms changed: 14 → 15
2026-07-30
Primary completion pushed: 2026-10-30 → 2033-07
2026-07-30
Completion pushed: 2027-05-12 → 2033-07
Trial Details
NCT Number NCT04198766
Lead Sponsor Inhibrx Biosciences, Inc
Collaborators: Merck Sharp & Dohme LLC
Conditions Solid Tumor, Non-Small Cell Lung Cancer, Head and Neck Cancer, Melanoma, Gastric Cancer, Renal Cell Carcinoma, Urothelial Carcinoma, Resectable Non-Small-Cell Lung Cancer
Enrollment 340 participants
Start Date 2019-12-10
Primary Completion 2033-07 (estimated)
Study Completion 2033-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-29