Non Hodgkin Lymphoma Clinical Trial
HMPL-760 Safety and Tolerability Study in Patients With Previously Treated CLL/SLL or NHL
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
HMPL-760 is a highly potent, selective, and reversible inhibitor against BTK, which would be studied in B-cell malignancy carrying either BTK(WT) or BTK(C481S).
This is a phase 1, open-label, multicenter, single-arm study to evaluate safety, tolerability, PK, PD, and preliminary efficacy of HMPL-760 in patients with previously treated CLL/SLL or NHL
The study consists of 2 parts:
Part 1- Dose Escalation to determine MTD and/or RP2D of HMPL-760
Part 2- Dose Expansion to characterize the safety and tolerability of HMPL-760
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.
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
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.
NOTE: Only key inclusion/exclusion criteria are listed. Full details are in the protocol.
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There are 35 Locations for this study
Anaheim California, 92801, United States
Atlanta Georgia, 30322, United States
New Orleans Louisiana, 70112, United States
Baltimore Maryland, 21287, United States
Kansas City Missouri, 64114, United States
Saint Louis Missouri, 63110, United States
Florham Park New Jersey, 07932, United States
New York New York, 10016, United States
Westbury New York, 11590, United States
El Paso Texas, 79915, United States
Houston Texas, 77030, United States
The Woodlands Texas, 79915, United States
Adelaide South Australia, 5000, Australia
Nice Alpes Maritimes, 6200, France
Paris cedex 12 Paris, 7551, France
Paris cedex 13 Paris, 75651, France
Villejuif cedex Val De Marne, 94805, France
Poitiers Vienne, 86021, France
Jerusalem , 91120, Israel
Petach-Tikva , 49414, Israel
Ramat Gan , 52620, Israel
Tel Aviv , 64239, Israel
Lazio Roma, 168, Italy
Candiolo Torino, 10060, Italy
Bologna , 40138, Italy
Milano , 20122, Italy
Katowice , 40-51, Poland
Legnica , 59-22, Poland
Skórzewo , 60-18, Poland
Toruń , 87-10, Poland
L'Hospitalet de Llobregat Barcelona, 8908, Spain
Pozuelo de Alarcon Madrid, 28223, Spain
Seville Sevilla, 41010, Spain
Barcelona , 8003, Spain
Madrid , 28033, Spain
Madrid , 28034, Spain
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