HMPL-760 Safety and Tolerability Study in Patients With Previously Treated CLL/SLL or NHL

Recruiting at 35 trial locations

Overseen By Rathi Pillai, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hutchison Medipharma Limited

Must not be taking: CYP3A4 drugs, PPIs

Disqualifiers: CNS lymphoma, Liver disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Trial Summary

What is the purpose of this trial?

This trial is testing HMPL-760, a new drug, in patients with certain blood cancers who have already tried other treatments. The drug works by blocking a protein that helps cancer cells grow, aiming to slow down or stop their growth.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) for some treatments, like oral targeted therapies and proton pump inhibitors, before starting the study treatment. If you're on these or other specific medications, you might need to stop them temporarily. It's best to discuss your current medications with the trial team to understand what changes might be needed.

Research Team

Vijay Jayaprakash, MBBS, PHD

Principal Investigator

Hutchison Medipharma Limited

Eligibility Criteria

Inclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part 1 of the study to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of HMPL-760

Up to 28 days

Dose Expansion

Part 2 of the study to characterize the safety and tolerability of HMPL-760

Up to 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• HMPL-760

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

All patients to receive HMPL-760 daily.

Who Is Running the Clinical Trial?

Hutchison Medipharma Limited

Lead Sponsor

Trials

104

Recruited

14,000+

Dr. Weiguo Su

Hutchison Medipharma Limited

Chief Executive Officer since 2022

PhD in Chemistry from Harvard University, BSc in Chemistry from Fudan University

Dr. Karen Atkin

Hutchison Medipharma Limited

Chief Medical Officer since 2023

MD from Harvard Medical School

Hutchmed

Lead Sponsor

Trials

38

Recruited

6,700+