NCT04727164

Study Investigating Safety,Tolerability,Pharmacokinetics and Antitumor Activities of HBM4003 Combine With Toripalimab

An Open Phase I Study to Evaluate the Safety, Tolerability, PK / PD, and Initial Efficacy of HBM4003 in Combination With Toripalimab in Patients With Advanced Melanoma and Other Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (estimated)
• Sponsor: Harbour BioMed (Guangzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

HBM4003 in combination with Toripalimab. The expected duration of treatment for each subject will vary according to the number of cycles completed; the number of cycles will depend on whether the subject benefits from the treatment. The study consists of a 4-week screening period, a 21-day treatment cycle (repeatable, depending on the presence/absence of clinical benefit), EOT visit after discontinuation of treatment, and 2 follow-up visits 28 days (± 2 days) and 84 days (± 5 days) after the last study medication.

Detailed description

An open-label Phase 1 study to evaluate the safety, tolerability, PK/PD and preliminary efficacy of HBM4003 combined with toripalimab in patients with advanced melanoma and other solid tumors. The study is composed of two part, part 1 will be approximately 31subjects and Part 2 will be approximately 30 subjects.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	HBM4003 and Triprilimab	Subjects will be treated with HBM4003 on Day 1 Cycle 1 and be treated with HBM4003 and Triprilimab during each 21-day cycles from Cycle 2 in part 1.Subjects will be treated with HBM4003 and Triprilimab on Day 1 during each 21-day cycle in part 2.

Timeline

• Start date: 2021-02-28
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2021-01-27
• Last updated: 2021-01-29