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

NCT05176691 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 2021-760-GLOB1
• Study Type: interventional
• Target: N/A
• Locations: 7 countries
• Sites: 36

Brief 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

Conditions

CLL/SLL; NHL; MCL; MZL; Lymphoplasmacytic Lymphoma; Waldenstrom Macroglobulinemia; Follicular Lymphoma; DLBCL; Richter Syndrome

Keywords

Lymphoplasmacytic lymphoma/Waldenstrom's macroglobulinemia; Chronic lymphocytic leukemia; Non-Hodgkin lymphoma; Mantle cell lymphoma; Marginal zone lymphoma; Follicular lymphoma; Diffuse large B-cell lymphoma; BTK inhibitor

Outcome Measures

Primary Outcomes (4)

• Incidence of DLTs

  Adverse event (AE) that meets protocol defined DLT criteria during dose escalation

  Up to 28 days after first dose of study drug

• Incidence of AEs/SAEs

  Any untoward medical occurrence associated with the use of study drug

  From 1st dose to within 30 days of last dose

• MTD

  To evaluate maximum tolerated dose of HMPL-760 in subjects, if reached

  From 1st dose to within 30 days of last dose

• RP2D

  To determine recommended phase 2 dose of HMPL-760 in subjects

  From 1st dose to within 30 days of last dose

Secondary Outcomes (7)

• Objective Response Rate (ORR)

  From 1st dose of study drug to the time of progressive disease, assessed up to 36 months

• Duration of Response (DoR)

  From first dose of study drug to the time of progressive disease, assessed up to 36 months

• Clinical Benefit Rate (CBR)

  From 1st dose of study drug to the time of progressive disease, assessed up to 36 months

• Progression-free Survival (PFS)

  From 1st dose of study drug to the time of progressive disease, assessed up to 36 months

• Maximum Plasma Concentration [Cmax]

  From 1st dose to within 30 days of last dose

Study Arms (1)

Treatment

EXPERIMENTAL

All patients to receive HMPL-760 daily.

Drug: HMPL-760

Interventions

HMPL-760 DRUG

Administered orally QD for 28-day cycles

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Hutchmed: lead

Study Sites (36)

Innovative Clinical Research

Anaheim, California, 92801, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Tulane Cancer Center

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins Clinical Research Center

Baltimore, Maryland, 21287, United States

Location

AMR Kansas City, Formerly Center for Pharmaceutical Research, an AMR company

Kansas City, Missouri, 64114, United States

Location

Center For Advanced Medicine

St Louis, Missouri, 63110, United States

Location

Summit Medical Group

Florham Park, New Jersey, 07932, United States

Location

New York University Langone Med Center. Lab

New York, New York, 10016, United States

Location

Clinical Research Alliance

Westbury, New York, 11590, United States

Location

Renovatio Clinical

El Paso, Texas, 79915, United States

Location

Oncology Consultants, P.A.

Houston, Texas, 77030, United States

Location

Renovatio Clinical

The Woodlands, Texas, 79915, United States

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Centre Antoine Lacassagne

Nice, Alpes Maritimes, 6200, France

Location

Hôpital Saint-Antoine

Paris, Paris, 7551, France

Location

Groupe Hospitalier Pitie-Salpetriere

Paris, Paris, 75651, France

Location

Institut Gustave Roussy

Villejuif, Val De Marne, 94805, France

Location

CHU Poitiers - Hôpital la Milétrie

Poitiers, Vienne, 86021, France

Location

Hadassah University Hospital - Ein Kerem

Jerusalem, 9112001, Israel

Location

Rabin Medical Center-Beilinson Campus

Petah Tikva, 4941492, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, 5262001, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lazio, Roma, 168, Italy

Location

Fondazione del Piemonte per l'Oncologia IRCC Candiolo

Candiolo, Torino, 10060, Italy

Location

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

Bologna, 40138, Italy

Location

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Pratia Onkologia Katowice

Katowice, 40-519, Poland

Location

Wojewodzki Szpital Specjalistyczny w Legnicy

Legnica, 59-220, Poland

Location

Centrum Medyczne Pratia Poznan

Skórzewo, 60-185, Poland

Location

MICS Centrum Medyczne Torun

Torun, 87-100, Poland

Location

ICO l'Hospitalet - Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, 8908, Spain

Location

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, Sevilla, 41010, Spain

Location

Hospital del Mar

Barcelona, 8003, Spain

Location

MD Anderson Cancer Centre

Madrid, 28033, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone; Waldenstrom Macroglobulinemia; Lymphoma, Follicular; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vijay Jayaprakash, MBBS, PHD

  Hutchison Medipharma Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: January 4, 2022
• Study Start: February 15, 2022
• Primary Completion: November 16, 2022
• Study Completion: November 16, 2022
• Last Updated: February 21, 2023

Record last verified: 2023-02

Locations

ES (6); US (12); PL (4); IL (4); FR (5); AU (1); IT (4)