HMPL-760 Safety and Tolerability Study in Patients With Previously Treated CLL/SLL or NHL
Leukemia
Lymphoma
Non-Hodgkin Lymphoma
18 Years and older, Male and Female
2021-760-GLOB1 (primary)
NCI-2022-01718
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
Objectives
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
Eligibility
- ECOG performance status of 0 or 1;
- Histologically confirmed NHL or CLL with disease progression or intolerance to either =2 prior regimens. Patients with CLL/SLL and indolent NHL must meet criteria for systemic therapy. Patients with gastric extranodal MZL who are H. pylori positive must have failed H. pylori eradication therapy.
- Availability of tumor sample: This may be an archival tissue sample obtained after most recent therapy or a fresh biopsy; if tumor sample is not available for patients in dose escalation, the Sponsor may waive the requirement after discussion.
- Dose expansion stage only: Patients must have been treated with 1 prior regimen containing a BTK inhibitor in cohorts 1 to 5;
- Expected survival of more than 24 weeks as determined by the Investigator.
Treatment Sites in Georgia
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