For Healthcare Professionals

Trial to Evaluate the Safety and Pharmacokinetics of HMPL-689 in Patients With Lymphomas


About the study

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

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


  1. (ECOG) performance status of 0 or 1;
  2. Histologically confirmed lymphoma (tumor types are restricted to CLL/SLL, FL (grade 1-3a), MCL, MZL, LPL/WM, PTCL or CBCL);
  3. Patients with relapsed or refractory NHL for whom:
  4. Standard of care treatment options no longer exist (Stage 1 only);
  5. Standard of care treatment options no longer exist with the exception of PI3K-delta inhibitors (Stage 2 only);
  6. Expected survival of more than 24 weeks.


Patients who meet any of the following criteria will be excluded from study entry:

  1. Primary central nervous system (CNS) lymphoma;
  2. Any of the following laboratory abnormalities Absolute neutrophil count; <1.0×10^9/L, Hemoglobin <80 g/L Platelets <50 ×10^9/L
  3. Inadequate organ function, defined by the following:
  4. Total bilirubin ≥1.5 times the upper limit of normal (× ULN);
  5. AST or ALT > 2.5 × ULN;
  6. Estimated creatinine clearance (CrCl) per Cockcroft-Gault;
  7. Dose Escalation stage of trial (Stage 1)
  8. CrCl < 40 mL/min;
  9. Dose Expansion stage of trial (Stage 2)
  10. CrCl <30 mL/min;
  11. International normalized ratio (INR) > 1.5 × ULN, activated partial thromboplastin time (aPTT) > 1.5 × ULN;
  12. Serum amylase or lipase > ULN at screening or known medical history of serum amylase or lipase > ULN;
  13. Patients with presence of second primary malignant tumors within the last 2 years;
  14. Clinically significant history of liver disease;
  15. Prior treatment with any PI3Kδ inhibitors;
  16. 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;
  17. Clinically significant active infection or interstitial lung diseases (including drug induced pneumonitis);
  18. Major surgical procedure within 4 weeks prior to initiation of study treatment;
  19. Adverse events from prior anti-neoplastic therapy that have not resolved to Grade less than or equal to 1, except for alopecia;
  20. New York Heart Association (NYHA) Class II or greater congestive heart failure;
  21. Congenital long QT syndrome or QTc >470 msec;
  22. Currently use medication known to cause QT prolongation or torsades de pointes;
  23. History of myocardial infarction or unstable angina within 6 months prior to initiation of study treatment;
  24. History of stroke or transient ischemic attack within 6 months prior to initiation of study treatment;
  25. Inability to take oral medication, prior surgical procedures affecting absorption, or active peptic ulcer disease;
  26. History of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis);
  27. Patients with ongoing chronic gastrointestinal diseases;
  28. 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.
pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.
Phone iconCall 9735673151Email iconEmail Study Center

Study’s details






Phase 1

Participants needed


Est. Completion Date

Aug 2023

Treatment type



Hutchmed identifier


Study number


Understanding Clinical Trials

Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?


Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.