HMPL-689 for Lymphoma

Recruiting at 35 trial locations

Overseen By Vijay Jayaprakash, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hutchison Medipharma Limited

Must not be taking: PI3Kδ inhibitors, Strong CYP3A4 inducers

Disqualifiers: CNS lymphoma, Liver disease, others

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

Compensation: Varies

Number of Visits: Unknown

53 Participants Needed

Trial Summary

What is the purpose of this trial?

An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability and PK of HMPL-689 in patients with relapsed or refractory lymphomas

Research Team

Claudia Huang

Principal Investigator

Hutchmed Limited

Nilanjan Ghosh, MD

Principal Investigator

Atrium Health Levine Cancer Institute

Jonathan B Cohen, MD

Principal Investigator

Emory Winship Cancer Institute

Eligibility Criteria

This trial is for patients with certain types of lymphoma that have relapsed or are not responding to standard treatments. Participants should be in relatively good physical condition (ECOG status 0 or 1) and expected to live more than 24 weeks. They must not have severe organ dysfunction, recent major surgery, heart issues like congestive heart failure, a history of significant liver disease, or any other condition that could interfere with the study.

Inclusion Criteria

I have NHL with no standard treatments left and am expected to live more than 24 weeks.

I am fully active or can carry out light work.

My lymphoma type is one of the specified types (e.g., CLL/SLL, FL grade 1-3a).

Exclusion Criteria

My cancer is a type of lymphoma that affects the brain.

Any of the following laboratory abnormalities Absolute neutrophil count; <1.0×10^9/L, Hemoglobin <80 g/L Platelets <50 ×10^9/L

Inadequate organ function, defined by the following: Total bilirubin ≥1.5 times the upper limit of normal (× ULN); AST or ALT > 2.5 × ULN; Estimated creatinine clearance (CrCl) per Cockcroft-Gault; Dose Escalation stage of trial (Stage 1) - CrCl < 40 mL/min; Dose Expansion stage of trial (Stage 2) - CrCl <30 mL/min; International normalized ratio (INR) > 1.5 × ULN, activated partial thromboplastin time (aPTT) > 1.5 × ULN; Serum amylase or lipase > ULN at screening or known medical history of serum amylase or lipase > ULN; Patients with presence of second primary malignant tumors within the last 2 years; Clinically significant history of liver disease; Prior treatment with any PI3Kδ inhibitors; Any prior use of the following: cancer therapy within 3 weeks of study treatment, GCSF within 7 days of screening, steroid therapy or targeted anti-neoplastic intent within 7 days of treatment, any use of strong CYP3A4 inducers within 2 weeks prior to initiation of study treatment, prior autologous transplant within 6 months of study treatment, prior allogenic stem cell transplant within 6 months of study treatment; Clinically significant active infection or interstitial lung diseases (including drug induced pneumonitis); Major surgical procedure within 4 weeks prior to initiation of study treatment; Adverse events from prior anti-neoplastic therapy that have not resolved to Grade less than or equal to 1, except for alopecia; New York Heart Association (NYHA) Class II or greater congestive heart failure; Congenital long QT syndrome or QTc >470 msec; Currently use medication known to cause QT prolongation or torsades de pointes; History of myocardial infarction or unstable angina within 6 months prior to initiation of study treatment; History of stroke or transient ischemic attack within 6 months prior to initiation of study treatment; Inability to take oral medication, prior surgical procedures affecting absorption, or active peptic ulcer disease; History of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis); Patients with ongoing chronic gastrointestinal diseases; Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of HMPL-689 to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)

Up to 4 cycles (16 weeks)

Weekly visits for dose adjustments and monitoring

Dose Expansion

Participants receive HMPL-689 at the RP2D to further characterize safety and explore preliminary anti-tumor activity

Up to 5 cycles (20 weeks)

Monthly visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• HMPL-689

Trial Overview The trial is testing HMPL-689's safety and how it's processed by the body in those with specific lymphomas that haven't responded well to other treatments. It's an open-label study where everyone knows what treatment they're getting, starting with small doses that increase over time.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

All patients take HMPL-689 taken 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+