HMPL-760 for Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma

No longer recruiting at 43 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HMPL-760 for individuals with certain blood cancers, specifically chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or non-Hodgkin lymphoma (NHL), who have not responded to other treatments. The trial focuses on assessing the safety, tolerability, behavior in the body, and early effectiveness of this treatment. Suitable candidates have CLL, SLL, or NHL that has progressed after at least two other treatments or if they couldn't tolerate those treatments. This trial offers an opportunity for those who continue to battle these cancers despite previous therapies. As a Phase 1 trial, the research aims to understand how the treatment works in people, allowing participants to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that HMPL-760 is likely to be safe for humans?

Research has shown that HMPL-760 is a new treatment under testing to assess its safety. It targets specific proteins involved in certain blood cancers, such as CLL/SLL and NHL. Early lab studies suggest that HMPL-760 is a strong and selective BTK inhibitor, capable of blocking specific cancer-related proteins.

As a Phase 1 trial, the primary goal is to determine HMPL-760's safety in humans. Phase 1 trials typically involve a small number of patients to evaluate how well they tolerate the treatment. Detailed results from this specific study are unavailable, and the trial was discontinued, limiting safety information from human studies. However, reaching this phase indicates that earlier tests did not reveal major safety concerns.

Prospective participants should discuss potential risks and benefits with their healthcare provider to understand what trial participation might entail. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about HMPL-760 because it offers a new approach to treating chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and non-Hodgkin's lymphoma (NHL). Unlike standard treatments like BTK inhibitors and monoclonal antibodies, HMPL-760 targets the Bruton’s tyrosine kinase (BTK) pathway in a unique way, potentially overcoming resistance seen in some current therapies. This novel mechanism of action could make HMPL-760 more effective for patients who have not responded well to existing treatments. Additionally, the daily oral administration of HMPL-760 may provide a more convenient option compared to some infusion-based therapies.

What evidence suggests that HMPL-760 might be an effective treatment for CLL/SLL or NHL?

Previous studies have shown that HMPL-760 holds promise in treating certain blood cancers, such as CLL/SLL and NHL. It blocks a protein called BTK, which aids the growth of these cancer cells. In lab tests with mice, this treatment made the tumors disappear completely. Notably, HMPL-760 has been effective against both the normal and a mutated form of BTK that some cancers develop. These early results suggest that HMPL-760 could be a strong option for treating these types of cancers. ^{1 3 6 7 8}

Who Is on the Research Team?

Vijay Jayaprakash, MBBS, PHD

Principal Investigator

Hutchison Medipharma Limited

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• HMPL-760

How Is the Trial Designed?

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+

Citations

1. hutch-med.com hutch-med.com/phase-i-study-of-btk-inhibitor-hmpl-760/

HUTCHMED Initiates Phase I Study of BTK Inhibitor HMPL- ... The Phase I study evaluates HMPL-760, a BTK inhibitor, in patients with previously treated B-cell Non-Hodgkin Lymphoma, including those with ...

2. synapse.patsnap.com synapse.patsnap.com/article/revolutionizing-b-cell-malignancy-treatment-the-emergence-of-hmpl-760-as-a-potent-and-selective-btk-inhibitor

The Emergence of HMPL-760 as a Potent and Selective ... HMPL-760 demonstrates dose-dependent antitumor efficacy in multiple B-cell lymphoma xenograft models in mice, with complete tumor regression in ...

3. library.ehaweb.org library.ehaweb.org/eha/2024/eha2024-congress/420141/ying.qian.results.from.a.phase.1.dose.escalation.study.of.hmpl-760.a.third.html

RESULTS FROM A PHASE 1 DOSE ESCALATION STUDY ... RESULTS FROM A PHASE 1 DOSE ESCALATION STUDY OF HMPL-760, A THIRD GENERATION, HIGHLY SELECTIVE, REVERSIBLE BTK INHIBITOR IN CHINESE PATIENTS WITH RELAPSED ...

4. researchgate.net researchgate.net/publication/369804842_Abstract_4020_HMPL-760_is_a_highly_potent_and_selective_reversible_BTK_inhibitor_targeting_BTK_and_BTKC481S_in_B-cell_malignancies

HMPL-760 is a highly potent and selective reversible BTK ... HMPL-760 displays dose-dependent antitumor efficacy in multiple human B cell lymphoma xenograft models in mice when orally administered at 3~50 ...

5. journals.lww.com journals.lww.com/hemasphere/fulltext/2022/06003/pb1880__a_multicenter_phase_1_study_evaluating_the.1760.aspx

a multicenter phase 1 study evaluating the safety ... HMPL-760 is a potent, selective, and reversible BTK inhibitor which can inhibit B-cell malignant tumor growth of either BTK WT or mutant BTK C481S.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05176691?tab=history

Record History | NCT05176691 HUTCHMED has decided to discontinue the HMPL 760 study. HMPL-760 Safety and Tolerability Study in Patients With Previously Treated CLL/​SLL or NHL.

7. hutch-med.com hutch-med.com/wp-content/uploads/2023/04/a230412_HKEX.pdf

HUTCHMED (China) Limited 和黃醫藥（中國）有限公司 The poster outlined preclinical data showing HMPL-760 is a reversible, selective, highly potent BTK inhibitor targeting both. BTKWT and BTKC481S ...

8. trial.medpath.com trial.medpath.com/drug/f0ed2191c2d7b5d1/hmpl-760

HMPL-760 - MedPath HMPL-760 Safety and Tolerability Study in Patients With Previously Treated CLL/SLL or NHL. 2022/01/04. NCT05176691. Phase 1. Withdrawn.