HMPL-760 Safety and Tolerability Study in Patients With Previously Treated CLL/SLL or NHL

Withdrawn before enrolling · Phase 1

Conditions studied: CLL/SLL, NHL, MCL, MZL, Lymphoplasmacytic Lymphoma, Waldenstrom Macroglobulinemia, Follicular Lymphoma, DLBCL, Richter Syndrome

In brief

An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-760 in patients with previously treated CLL/SLL or NHL

Key facts

Study ID

NCT05176691

Run by

Hutchmed

People needed

0

Starts

2022-02-15

Expected to finish

2022-11-16

Last updated by the study team

2023-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ECOG performance status of 0 or 1;
• Histologically confirmed NHL or CLL with disease progression or intolerance to either ≥2 prior regimens. Patients with CLL/SLL and indolent NHL must meet criteria for systemic therapy. Patients with gastric extranodal MZL who are H. pylori positive must have failed H. pylori eradication therapy.
• Availability of tumor sample: This may be an archival tissue sample obtained after most recent therapy or a fresh biopsy; if tumor sample is not available for patients in dose escalation, the Sponsor may waive the requirement after discussion.
• Dose expansion stage only: Patients must have been treated with 1 prior regimen containing a BTK inhibitor in cohorts 1 to 5;
• Expected survival of more than 24 weeks as determined by the Investigator.

You may not qualify if…

• Patients with primary central nervous system lymphoma.
• Any of the following laboratory abnormalities:
• Absolute neutrophil count (ANC) <0.75×109/L
• Hemoglobin <8 mg/L
• Platelets <50×109/L
• Note: In the dose expansion stage, patients with cell counts below the thresholds listed above may be considered eligible if there is documented bone marrow infiltration and Sponsor approval
• Inadequate organ function
• International normalized ratio (INR) >1.5×ULN, activated partial thromboplastin time (aPTT) >1.5×ULN
• Patients requiring anticoagulation therapy (except vitamin K antagonists [ie, warfarin]) but with a stable INR within the recommended range according to the local guideline are eligible.
• Patients with presence of second primary malignant tumors within the last 2 years, with the exception of the following:
• Basal cell carcinoma of the skin
• Squamous cell carcinoma of the skin
• Carcinoma in situ of the cervix
• Carcinoma in situ of the breast
• Clinically significant history of liver disease, including cirrhosis or current known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV).
• Cancer therapy, including chemotherapy, hormonal therapy, biologic therapy, vaccine, or radiotherapy within 3 weeks prior to initiation of study treatment. For oral targeted therapies, a washout period of 5 half-lives of the agent (minimum 3 days) prior to the initiation of study treatment can be used.
• Any granulocyte colony-stimulating factor treatment/blood transfusion within 7 days before the screening hematology test.
• Prior use of any drug that is a strong inducer or inhibitor of CYP3A4 within 2 weeks prior to initiation of study treatment.
• Prior use of proton pump inhibitors (PPIs) within 5 days of study treatment
• Any transplant within 100 days prior to initiation of study treatment
• Clinically significant active infection or with an unexplained fever.
• Treatment within a clinical study of an investigational agent or using an investigational device within 3 weeks prior to initiation of the current study treatment.
• AEs from prior antineoplastic therapy that have not resolved to grade <1
• Pregnant (positive urine or serum beta human chorionic gonadotropin test) or lactating women.
• New Your Heart Association (NYHA) class II or greater congestive heart failure.

Where it is running

• Innovative Clinical Research — Anaheim, California, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Tulane Cancer Center — New Orleans, Louisiana, United States
• Johns Hopkins Clinical Research Center — Baltimore, Maryland, United States
• AMR Kansas City, Formerly Center for Pharmaceutical Research, an AMR company — Kansas City, Missouri, United States
• Center For Advanced Medicine — St Louis, Missouri, United States
• Summit Medical Group — Florham Park, New Jersey, United States
• New York University Langone Med Center. Lab — New York, New York, United States
• Clinical Research Alliance — Westbury, New York, United States
• Renovatio Clinical — El Paso, Texas, United States
• Oncology Consultants, P.A. — Houston, Texas, United States
• Renovatio Clinical — The Woodlands, Texas, United States
• Royal Adelaide Hospital — Adelaide, South Australia, Australia
• Centre Antoine Lacassagne — Nice, Alpes Maritimes, France
• Hôpital Saint-Antoine — Paris, Paris, France
• Groupe Hospitalier Pitie-Salpetriere — Paris, Paris, France
• Institut Gustave Roussy — Villejuif, Val De Marne, France
• CHU Poitiers - Hôpital la Milétrie — Poitiers, Vienne, France
• Hadassah University Hospital - Ein Kerem — Jerusalem, Israel
• Rabin Medical Center-Beilinson Campus — Petah Tikva, Israel
• Chaim Sheba Medical Center — Ramat Gan, Israel
• Tel Aviv Sourasky Medical Center — Tel Aviv, Israel
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Lazio, Roma, Italy
• Fondazione del Piemonte per l'Oncologia IRCC Candiolo — Candiolo, Torino, Italy
• Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS — Bologna, Italy

Full record on ClinicalTrials.gov

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