drugset / Trial / NCT04135261

A Study Evaluating the Safety, Tolerance and Anti-tumor Activity of a Study Drug in Subjects With Advanced Solid Tumors

NCT04135261

Phase 1 Completed 65 enrolled Harbour BioMed US, Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a study to evaluate the safety and tolerability of the study drug HBM4003, and to determine the maximum tolerated dose and/or recommended Phase 2 study dose of HBM4003. The study will also look at the anti-tumor activity of HBM4003.The study consists of 2 parts. In Part 1, patients are enrolled into different cohort doses in order to identify the appropriate recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD). In Part 2, participants with metastatic/unresectable melanoma will receive the MTD and/or RP2D established in Part 1 of the study. In Part 1 and Part 2, participants will be administered treatment either once per week or once every 3 weeks. NOTE: Participants are no longer being recruited to this study.

Timeline

Start
2019-09-24
Primary completion
2023-01-17
Completion
2023-02-15

Drugs

EvaluationDrugModalityDoseRoute
Subject PORUSTOBART Monoclonal antibody Intravenous

Indications