NCT04861779

A Study of HSK29116 in Adults With Relapsed/Refractory B-cell Malignancies

A Phase Ia/b Clinical Study on Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of BTK Protein Degradation Agent HSK29116 in Subjects With Relapsed or Refractory B-Cell Malignancy

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human Phase 1a/1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of HSK29116 in patients with advanced B-cell malignancies.

Detailed description

This study is divided into 2 parts. Phase 1a is a dose escalation to evaluate the safety and tolerability of HSK29116 in adult patients with relapsed/refractory (R/R) B-cell malignancies, who have required and received at least 2 prior systemic therapy and for whom no other therapies are known to provide clinical benefit. Phase 1b will investigate the efficacy of HSK29116 at the dose selected in Phase 1a in up to 3 cohorts of patients with R/R B-cell malignancy indications who have received at least 2 prior systemic therapy： Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)； Mantle Cell Lymphoma (MCL)； Other B-cell malignancies (they will be selected according to the preliminary results of Phase Ia)

Conditions

• Relapsed/Refractory B-Cell Malignancies

Interventions

Type	Name	Description
DRUG	HSK29116	Oral HSK29116

Timeline

• Start date: 2021-08-24
• Primary completion: 2023-08-01
• Completion: 2023-10-01
• First posted: 2021-04-27
• Last updated: 2022-08-03

Locations

8 sites across 2 countries: Australia, China