For Healthcare Professionals

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

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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
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Who can take part

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

INCLUSION 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.

EXCLUSION CRITERIA

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.
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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


Contition

Lymphoma

Age

18+

Phase

Phase 1

Participants needed

270

Est. Completion Date

Aug 2023

Treatment type

Interventional


Sponsor

Hutchmed

ClinicalTrials.gov identifier

NCT03786926

Study number

2018-689-00US1

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