HMPL-306 for Blood Cancers

Recruiting at 16 trial locations

Overseen By Iris Carton, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hutchmed

Must not be taking: QT-prolonging drugs

Disqualifiers: Pregnancy, Severe infection, Heart conditions, others

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

Compensation: Varies

Number of Visits: Unknown

46 Participants Needed

Trial Summary

What is the purpose of this trial?

An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-306 in subjects with advanced relapsed, refractory, or resistant hematological malignancies that harbor IDH mutations.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking medications that prolong the QT interval (a heart rhythm measure), you may not be eligible. Also, if you have taken an investigational agent, there must be a 14-day gap before starting the study drug.

Research Team

Bo Zhang

Principal Investigator

Hutchison Medipharma Limited

Eligibility Criteria

This trial is for adults over 18 with advanced blood cancers that have come back or haven't responded to treatment, and who are not too sick to participate (ECOG ≤ 2). They mustn't be pregnant/breastfeeding, have severe infections, certain heart conditions, uncontrolled cancer complications, specific liver/gastrointestinal diseases, or poor organ function. Those allergic to HMPL-306 or its ingredients can't join.

Inclusion Criteria

I am 18 years old or older.

My blood cancer has come back or hasn't responded to treatment.

I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

I haven't had any new cancers in the last 2 years, except for certain skin cancers or early-stage cervical or breast cancer.

Subjects with a known hypersensitivity to HMPL-306 or to any of its excipients

I do not have a severe infection or unexplained fever over 38.3°C.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive HMPL-306 to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)

4 weeks

Weekly visits for dose escalation monitoring

Dose Expansion

Participants receive the MTD/RP2D of HMPL-306 to evaluate safety and efficacy

Up to 36 months

Monthly visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• HMPL-306

Trial Overview The study tests HMPL-306's safety and effectiveness in patients with blood cancers containing IDH mutations. It's an open-label trial where all participants receive the drug; researchers will monitor how the body processes it and any signs of cancer improvement.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

All patients will be administered HMPL-306 orally QD

Who Is Running the Clinical Trial?

Hutchmed

Lead Sponsor

Trials

38

Recruited

6,700+

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