Non Hodgkin Lymphoma Clinical Trial

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

Summary

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

View Full Description

Full Description

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Patients with primary central nervous system lymphoma.

Any of the following laboratory abnormalities:

Absolute neutrophil count (ANC) <0.75×109/L
Hemoglobin <8 mgL
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.

NOTE: Only key inclusion/exclusion criteria are listed. Full details are in the protocol.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

168

Study ID:

NCT05176691

Recruitment Status:

Recruiting

Sponsor:

Hutchmed

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There are 35 Locations for this study

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Innovative Clinical Research
Anaheim California, 92801, United States More Info
Richy Agajinian, MD
Contact
Richy Agajinian, MD
Principal Investigator
Emory University Hospital
Atlanta Georgia, 30322, United States More Info
Jonathon Cohen, MD
Contact
404-778-2214
[email protected]
Jonathon Cohen, MD
Principal Investigator
Tulane Cancer Center
New Orleans Louisiana, 70112, United States More Info
Nakhle Saba, MD
Contact
Nakhle Saba, MD
Principal Investigator
Johns Hopkins Clinical Research Center
Baltimore Maryland, 21287, United States More Info
Nina Wagner-Johnston, MD
Contact
410-955-8893
[email protected]
Nina Wagner-Johnston, MD
Principal Investigator
AMR Kansas City, Formerly Center for Pharmaceutical Research, an AMR company
Kansas City Missouri, 64114, United States More Info
Jaswinder Singh, MD
Contact
816-276-4227
[email protected]
Jaswinder Singh, MD
Principal Investigator
Center For Advanced Medicine
Saint Louis Missouri, 63110, United States More Info
Brittany Depp
Contact
314-362-7102
[email protected]
Brad Kahl, MD
Contact
314-747-7222
[email protected]
Brad Kahl, MD
Principal Investigator
Summit Medical Group
Florham Park New Jersey, 07932, United States More Info
Kelly Ritter
Contact
908-277-8747
[email protected]
David Gallinson, MD
Contact
973-538-5210
[email protected]
David Gallinson, MD
Principal Investigator
New York University Langone Med Center. Lab
New York New York, 10016, United States More Info
Catherine Diefenbach, MD
Contact
Catherine Diefenbach, MD
Principal Investigator
Clinical Research Alliance
Westbury New York, 11590, United States More Info
Morton Coleman, MD
Contact
Morton COleman, MD
Principal Investigator
Renovatio Clinical
El Paso Texas, 79915, United States More Info
Haroutioun Shahinian, MD
Contact
713-703-2398
[email protected]
Haroutioun Shahinian, MD
Principal Investigator
Oncology Consultants, P.A.
Houston Texas, 77030, United States More Info
Julio Peguero, MD
Contact
713-600-0900
[email protected]
Julio Peguero, MD
Principal Investigator
Renovatio Clinical
The Woodlands Texas, 79915, United States More Info
Jonathan Lu, MD
Contact
713-703-2398
[email protected]
Jonathan Lu, MD
Principal Investigator
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia More Info
Pratyush Giri, MD
Contact
Pratyush Giri, MD
Principal Investigator
Centre Antoine Lacassagne
Nice Alpes Maritimes, 6200, France More Info
Frédéric Peyrade, MD
Contact
Frédéric Peyrade, MD
Principal Investigator
Hôpital Saint-Antoine
Paris cedex 12 Paris, 7551, France More Info
Zora Marjanovic, MD
Contact
Zora Marjanovic, MD
Principal Investigator
Groupe Hospitalier Pitie-Salpetriere
Paris cedex 13 Paris, 75651, France More Info
Sylvain Choquet, MD
Contact
Sylvain Choquet, MD
Principal Investigator
Institut Gustave Roussy
Villejuif cedex Val De Marne, 94805, France More Info
Vincent Ribrag, MD
Contact
Vincent Ribrag, MD
Principal Investigator
CHU Poitiers - Hôpital la Milétrie
Poitiers Vienne, 86021, France More Info
Cécile Tomowiak, MD
Contact
Cécile Tomowiak, MD
Principal Investigator
Hadassah University Hospital - Ein Kerem
Jerusalem , 91120, Israel More Info
Neta Goldschmidt, MD
Contact
Neta Goldschmidt, MD
Principal Investigator
Rabin Medical Center-Beilinson Campus
Petach-Tikva , 49414, Israel More Info
Ronit Gurion, MD
Contact
Ronit Gurion, MD
Principal Investigator
Chaim Sheba Medical Center
Ramat Gan , 52620, Israel More Info
Ohad Benjamini, MD
Contact
Ohad Benjamini, MD
Principal Investigator
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel More Info
Yair Herishanu, MD
Contact
Yair Herishanu, MD
Principal Investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lazio Roma, 168, Italy More Info
Luca Laurenti, MD
Contact
Laurenti Luca, MD
Principal Investigator
Fondazione del Piemonte per l'Oncologia IRCC Candiolo
Candiolo Torino, 10060, Italy More Info
Umberto Vitolo, MD
Contact
Umberto Vitolo, MD
Principal Investigator
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna , 40138, Italy More Info
Pier Luigi Zinzani, MD
Contact
Pier Luigi Zinzani, MD
Principal Investigator
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milano , 20122, Italy More Info
Gianluigi Reda, MD
Contact
Gianluigi Reda, MD
Principal Investigator
Pratia Onkologia Katowice
Katowice , 40-51, Poland More Info
Sebastian Grosicki, MD
Contact
Sebastian Grosicki, MD
Principal Investigator
Wojewodzki Szpital Specjalistyczny w Legnicy
Legnica , 59-22, Poland More Info
Jadwiga Holojda, MD
Contact
Jadwiga Holojda, MD
Principal Investigator
Centrum Medyczne Pratia Poznan
Skórzewo , 60-18, Poland More Info
Lukasz Pruchniewski, MD
Contact
Lukasz Pruchniewski, MD
Principal Investigator
MICS Centrum Medyczne Torun
Toruń , 87-10, Poland More Info
Dominik Chraniuk, MD
Contact
Dominik Chraniuk, MD
Principal Investigator
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat Barcelona, 8908, Spain More Info
Eva Gonzalez Barca, MD
Contact
Eva Gonzalez Barca, MD
Principal Investigator
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcon Madrid, 28223, Spain More Info
Carmen Martinez Chamorro, MD
Contact
Carmen Martinez Chamorro, MD
Principal Investigator
Hospital Universitario Virgen del Rocio
Seville Sevilla, 41010, Spain More Info
Fatima De la Cruz Vicente, MD
Contact
Fatima De la Cruz Vicente, MD
Principal Investigator
Hospital del Mar
Barcelona , 8003, Spain More Info
Antonio Salar Silvestre, MD
Contact
Antonio Salar Silvestre, MD
Principal Investigator
MD Anderson Cancer Centre
Madrid , 28033, Spain More Info
Adolfo de la Fuente Burguera, MD
Contact
Adolfo de la Fuente Burguera, MD
Principal Investigator
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain More Info
Javier Lopez Jimenez, MD
Contact
Javier Lopez Jimenez, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

168

Study ID:

NCT05176691

Recruitment Status:

Recruiting

Sponsor:


Hutchmed

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