Trials / Withdrawn
WithdrawnNCT05176691
HMPL-760 Safety and Tolerability Study in Patients With Previously Treated CLL/SLL or NHL
A Multicenter, Open-label, Phase 1 Study Evaluating the Safety and Tolerability of HMPL-760 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Other Non-Hodgkin Lymphoma (NHL)
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Hutchmed · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-760 in patients with previously treated CLL/SLL or NHL
Detailed description
HMPL-760 is a highly potent, selective, and reversible inhibitor against BTK, which would be studied in B-cell malignancy carrying either BTK(WT) or BTK(C481S). This is a phase 1, open-label, multicenter, single-arm study to evaluate safety, tolerability, PK, PD, and preliminary efficacy of HMPL-760 in patients with previously treated CLL/SLL or NHL The study consists of 2 parts: Part 1- Dose Escalation to determine MTD and/or RP2D of HMPL-760 Part 2- Dose Expansion to characterize the safety and tolerability of HMPL-760
Conditions
- CLL/SLL
- NHL
- MCL
- MZL
- Lymphoplasmacytic Lymphoma
- Waldenstrom Macroglobulinemia
- Follicular Lymphoma
- DLBCL
- Richter Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HMPL-760 | Administered orally QD for 28-day cycles |
Timeline
- Start date
- 2022-02-15
- Primary completion
- 2022-11-16
- Completion
- 2022-11-16
- First posted
- 2022-01-04
- Last updated
- 2023-02-21
Locations
36 sites across 7 countries: United States, Australia, France, Israel, Italy, Poland, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05176691. Inclusion in this directory is not an endorsement.