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

  • End date
    Aug 31, 2023
  • participants needed
  • sponsor
    Hutchison Medipharma Limited
Updated on 22 December 2021


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


This is a Phase 1, open-label, multicenter study of HMPL-689 administered orally to patients with relapsed or refractory lymphoma.

HMPL-689 is a selective and potent small molecule inhibitor targeting the isoform phosphoinositide 3'-kinase delta (PI3Kδ), a key component in the B-cell receptor signaling pathway

This study will consist of a dose escalation stage (Stage 1) and a dose expansion stage (Stage 2).

Dose Escalation Stage (Stage 1):

This stage will end when any of the following criteria is met:

  • The dose level 1 demonstrates an excessive toxicity, ie, 3 dose limiting toxicities (DLTs) are observed out of the first 3 patients at dose level 1.
  • The maximum sample size is reached.
  • The MTD and/or RP2D is confirmed.

Dose Expansion Stage (Stage 2):

To further characterize the safety and explore the preliminary anti-tumor activity of HMPL-689 at RP2D, patients with B cell lymphoma will be enrolled in the dose expansion stage.

Condition Lymphoma
Treatment HMPL-689
Clinical Study IdentifierNCT03786926
SponsorHutchison Medipharma Limited
Last Modified on22 December 2021


Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Patients who meet any of the following criteria will be excluded from study
Primary central nervous system (CNS) lymphoma
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
Clinically significant history of liver disease
time (aPTT) > 1.5 × ULN
Serum amylase or lipase > ULN at screening or known medical history of serum amylase or lipase > ULN
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
Patients with presence of second primary malignant tumors within the last 2 years
Major surgical procedure within 4 weeks prior to initiation of study treatment
Prior treatment with any PI3Kδ inhibitors
Adverse events from prior anti-neoplastic therapy that have not resolved to Grade less than or equal to 1, except for alopecia
Clinically significant active infection or interstitial lung diseases (including drug induced pneumonitis)
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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note