HMPL-306 for Blood Cancers

Recruiting in Palo Alto (17 mi)

+16 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Hutchmed

Must not be taking: QT-prolonging drugs

Disqualifiers: Pregnancy, Severe infection, Heart conditions, others

No Placebo Group

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.

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.

+8 more

Trial 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

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

All patients will be administered HMPL-306 orally QD