Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · October 16, 2026
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Phase 1/2 Trial.
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Registry record from ClinicalTrials.gov (NCT07038343). This is a study registration, not published results. Lead sponsor: Avenzo Therapeutics, Inc.. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 480 participants (ESTIMATED). Conditions: Solid Tumor Cancer, Locally Advanced, Metastatic Solid Tumors, Lung Cancers, Epithelial Tumor, Biliary Tract Cancer (BTC), Urothelial Cancer, Nasopharyngeal Cancers. Interventions: DRUG: AVZO-1418; DRUG: Combination Agent 1; DRUG: Combination Agent 2. Primary outcome measures: Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1) , Approximately 2 years; Determine the maximum tolerated dose (MTD) and/or preliminary recommended Phase 2 dose (RP2D) (Phase 1) , Approximately 16 months; Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1) , From baseline until end of study treatment or study completion (approximately 2 years); Objective Response Rate (ORR) (Phase 2) , From baseline through disease progression or study completion (approximately 2 years). Brief summary: This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a monotherapy and potentially in combination therapy to patients with locally advanced or metastatic epithelial solid tumors.