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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · November 6, 2026
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Phase 1/2 Trial.
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Registry record from ClinicalTrials.gov (NCT04198766). This is a study registration, not published results. Lead sponsor: Inhibrx Biosciences, Inc. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 340 participants (ESTIMATED). 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. Interventions: DRUG: INBRX-106 - Hexavalent OX40 agonist antibody; DRUG: pembrolizumab 200 mg; DRUG: pembrolizumab 400 mg; DRUG: Carboplatin AUC-5; DRUG: Carboplatin AUC-6; DRUG: Pemetrexed 500 mg/m2; DRUG: Cisplatin 75mg/m2; DRUG: Paclitaxel 200mg/m2; DRUG: Nab paclitaxel 100mg/m2; DRUG: Gemcitabine (1000 mg/m2). Primary outcome measures: Frequency of adverse events of INBRX-106 as single agent and in combination with pembrolizumab , ~2 years; Severity of adverse events of INBRX-106 as single agent and in combination with pembrolizumab , ~2 years; MTD and/or RP2D of INBRX-106 as single agent and in combination with pembrolizumab , ~2 years; Antitumor activity of INBRX-106 in combination with pembrolizumab in expansion cohorts , ~2 years; 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 , ~2 years; 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) , ~2 years. Brief 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.