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Phase Ia/Ib Study of FXB0871 Monotherapy in Locally Advanced/Metastatic Solid Tumors

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
This is a phase 1a/1b, open-label, multicenter, dose-escalation and dose-expansion study evaluating the safety, tolerability, antitumor activity, pharmacokinetics, and pharmacodynamics of FXB0871 monotherapy in adults with selected locally advanced or metastatic solid tumors. In Part Ia, participants with selected solid tumors that have progressed after, are intolerant to, or are not suitable for standard therapy will receive FXB0871 in dose-escalation cohorts to determine the maximum tolerated dose and/or recommended phase 2 dose. In Part Ib, participants with PD-(L)1-resistant non-small cell lung cancer or hepatocellular carcinoma will receive FXB0871 in dose-expansion cohorts to further evaluate antitumor activity, safety, and dose optimization.
Trial Details
NCT Number NCT07558200
Lead Sponsor Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Conditions
(from sponsor)		 Solid Tumors, Non-Small Cell Lung Cancer, Hepatocellular Carcinoma
Related terms Carcinoma, Hepatocellular, Carcinoma, Non-Small-Cell Lung
Enrollment 138 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov