HMPL-760 / Hutchmed - LARVOL DELTA

Study of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Relapsed/Refractory DLBCL (clinicaltrials.gov) - P2 | N=61 | Active, not recruiting | Sponsor: Hutchmed | Recruiting ➔ Active, not recruiting

Enrollment closed • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

2021-760-00CH1: HMPL-760 in Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P1 | N=89 | Completed | Sponsor: Hutchmed | Recruiting ➔ Completed | Trial completion date: Apr 2026 ➔ Jan 2025 | Trial primary completion date: Jul 2024 ➔ Jan 2025

Trial completion • Trial completion date • Trial primary completion date • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Study of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Relapsed/Refractory DLBCL (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Hutchmed | Not yet recruiting ➔ Recruiting

Enrollment open • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Study of HMPL-760 Puls R-GemOx Versus Placebo Plus R-GemOx in Relapsed/Refractory DLBCL (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Hutchmed

New P2 trial • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

RESULTS FROM A PHASE 1 DOSE ESCALATION STUDY OF HMPL-760, A THIRD GENERATION, HIGHLY SELECTIVE, REVERSIBLE BTK INHIBITOR IN CHINESE PATIENTS WITH RELAPSED/REFRACTORY (R/R) LYMPHOMAS (EHA 2024) - P1 | "HMPL-760 was well tolerated and the RP2D was determined to be 400 mg QD orally. It exhibited dose-proportional PK, a manageable toxicity profile, and promising single-agent clinical activity in R/R B-NHL(including post-BTKi) patients. The dose expansion study is ongoing, evaluating the safety and efficacy ofHMPL-760 in patients with various R/R B-NHL."

Clinical • P1 data • Anemia • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Hepatology • Infectious Disease • Liver Failure • Lymphoma • Lymphoplasmacytic Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Respiratory Diseases • Tuberculosis • CCL3

HUTCHMED Highlights Sovleplenib Phase III ESLIM-01 Study and Hematological Malignancy Programs Data to be Presented at the upcoming EHA2024 Congress (GlobeNewswire) - "HUTCHMED (China) Limited...announces that...new and updated data related to novel investigational hematological malignancy therapies HMPL-306, HMPL-760 and tazemetostat, will be presented at the upcoming European Hematology Association ('EHA') Hybrid Congress."

Clinical data • Acute Myelogenous Leukemia • Lymphoma

HMPL-760 is a highly potent and selective reversible BTK inhibitor, targeting BTK and BTKC481S in B-cell malignancies (AACR 2023) - P1 | "First-generation BTK inhibitors such as ibrutinib covalently binds to a cysteine residue (C481) of BTK. HMPL-760 is a reversible, selective, highly potent, BTK inhibitor targeting both BTKWT and BTKC481S. The first-in-human Phase 1 clinical trials of HMPL-760 are under way in patients with r/r B-NHL (NCT05190068, NCT05176691)."

Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD69

HUTCHMED Highlights Presentations at American Association for Cancer Research Annual Meeting 2023 (GlobeNewswire) - "HUTCHMED (China) Limited...announces that new and updated clinical and non-clinical data related to five HUTCHMED investigational drug candidates will be presented during the American Association for Cancer Research Annual Meeting 2023 (AACR 2023)....HMPL-760:...The poster outlined preclinical data showing HMPL-760 is a reversible, selective, highly potent BTK inhibitor targeting both BTKWT and BTKC481S."

Preclinical • Hematological Malignancies • Oncology

A MULTICENTER PHASE 1 STUDY EVALUATING THE SAFETY AND TOLERABILITY OF HMPL-760 IN PATIENTS WITH PREVIOUSLY TREATED CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA OR OTHER NON-HODGKIN LYMPHOMA (EHA 2022) - P1 | "Contemp Clin Trials . 2015;45:426-34 Results N/A Conclusion N/A"

Clinical • IO biomarker • P1 data • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • Small Lymphocytic Lymphoma • Solid Tumor • Waldenstrom Macroglobulinemia

HMPL-760 Safety and Tolerability Study in Patients With Previously Treated CLL/SLL or NHL (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Hutchmed | N=168 ➔ 0 | Trial completion date: Oct 2025 ➔ Nov 2022 | Recruiting ➔ Withdrawn | Trial primary completion date: Apr 2025 ➔ Nov 2022

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • Small Lymphocytic Lymphoma • Waldenstrom Macroglobulinemia • CCL2

HMPL-760 in Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Hutchison Medipharma Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

HMPL-760 Safety and Tolerability Study in Patients With Previously Treated CLL/SLL or NHL (clinicaltrials.gov) - P1 | N=168 | Recruiting | Sponsor: Hutchison Medipharma Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Richter's Syndrome • Small Lymphocytic Lymphoma • Waldenstrom Macroglobulinemia • CCL2

HMPL-760 in Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (clinicaltrials.gov) - P1; N=100; Not yet recruiting; Sponsor: Hutchison Medipharma Limited

Clinical • New P1 trial • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

HUTCHMED Initiates Phase I Study of BTK Inhibitor HMPL-760 in Patients with Previously Treated B-Cell Non-Hodgkin Lymphoma in China (GlobeNewswire) - "HUTCHMED (China) Limited...has initiated a Phase I study in China of HMPL-760, a highly potent, selective, and reversible inhibitor with long target engagement against Bruton’s tyrosine kinase ('BTK'), including wild-type and C481S-mutated BTK. The first patient received their first dose on January 4, 2022. The clinical study is a multi-center, open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy profile of HMPL-760. The study is enrolling patients with previously treated chronic lymphocytic leukemia/​small lymphocytic lymphoma (CLL/SLL) or other types of Non-Hodgkin Lymphoma..."

Trial status • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma