HMPL-295 / Hutchmed - LARVOL DELTA

A Study of HMPL-295S1 in Patients With Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=47 | Completed | Sponsor: Hutchmed | Recruiting ➔ Completed | N=87 ➔ 47 | Trial completion date: May 2024 ➔ Feb 2024 | Trial primary completion date: Sep 2023 ➔ Jan 2024

Enrollment change • Metastases • Trial completion • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Oncology • Solid Tumor

First-in-human study of HMPL-295, an ERK1/2 inhibitor, in patients with advanced solid tumors: Dose-escalation results of monotherapy. (ASCO 2024) - P1 | "Considering safety, tolerability, PK/PD and preliminary efficacy results, RP2D was determined to be 50 mg QD. Clinical trial information: NCT04908046."

Clinical • Metastases • Monotherapy • P1 data • Acute Kidney Injury • Anemia • Dermatitis • Dermatology • Endometrial Cancer • Gastrointestinal Cancer • Hematological Disorders • Immunology • Lung Cancer • Nephrology • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Renal Disease • Small Intestinal Carcinoma • Solid Tumor

Preclinical characterization of HMPL-295, a potent and selective ERK 1/2 inhibitor (AACR 2024) - P1 | "HMPL-295 is a potent and selective ERK1/2 inhibitor which demonstrates strong anti-tumor activity in preclinical models, supporting further clinical evaluation."

Preclinical • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • CCND1 • KRAS

HUTCHMED Highlights Data to be Presented at AACR Congress 2024 (GlobeNewswire) - "Other presentations include preclinical data on the ERK 1/2 inhibitor, HMPL-295; early clinical data on the Syk inhibitor, sovleplenib, in lymphoma patients; additional clinical data from global studies of VEGFR inhibitor, fruquintinib, and MET inhibitor, savolitinib; and several investigator-initiated studies of fruquintinib and VEGFR/CSF-1R/FGFR inhibitor, surufatinib."

Clinical data • Preclinical • Lymphoma

A first-in-human, open-label, dose-escalation study of ERK1/2 inhibitor HMPL-295 in patients with advanced solid tumors (ESMO Asia 2023) - P1 | "Conclusions Combining safety, tolerability, PK/PD and preliminary efficacy results, the continuous-administration MTD was determined to be 50 mg QD. Intermittent-administration dose-escalation is currently ongoing."

Clinical • Metastases • P1 data • Endometrial Cancer • Oncology • Small Intestinal Carcinoma • Solid Tumor

HUTCHMED Highlights Clinical Data to be Presented at 2023 ESMO Asia and ESMO Immuno-Oncology Congresses (GlobeNewswire) - "HUTCHMED (China) Limited...highlights that new clinical data from several ongoing studies with HUTCHMED investigational drug candidates...which will be presented at the upcoming European Society for Medical Oncology ('ESMO') Asia Congress...and the ESMO Immuno-Oncology Congress....This presentation will report data from a multi-center, open-label clinical trial to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy profile of HMPL-295, and to determine the maximum tolerated dose ('MTD') and recommended Phase II dose in patients with advanced malignant solid tumors. The continuous-administration MTD was determined to be 50 mg QD, and intermittent administration studies are ongoing."

P1 data • Solid Tumor

A Study of HMPL-295S1 in Patients With Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1 | N=87 | Recruiting | Sponsor: Hutchison Medipharma Limited | Trial primary completion date: Nov 2022 ➔ Sep 2023

Trial primary completion date • Gastrointestinal Cancer • Oncology • Solid Tumor

A Study of HMPL-295S1 in Patients With Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1; N=87; Recruiting; Sponsor: Hutchison Medipharma Limited; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Gastrointestinal Cancer • Oncology • Solid Tumor

HUTCHMED Initiates Phase I Trials of novel ERK inhibitor HMPL 295 in Patients with Advanced Solid Tumors in China (GlobeNewswire) - "HUTCHMED (China) Limited...has initiated a Phase I study of HMPL-295, its investigative and highly selective oral inhibitor of ERK, which is a downstream component of the RAS-MAPK1 pathway signaling cascade...The clinical trial is a multi-center, open-label study to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy profile of HMPL-295, and to determine the maximum tolerated dose and recommended Phase II dose ('RP2D') in patients with advanced malignant solid tumors."

Trial initiation date • Oncology • Solid Tumor

A Study of HMPL-295S1 in Patients With Advanced Malignant Solid Tumors (clinicaltrials.gov) - P1; N=87; Not yet recruiting; Sponsor: Hutchison Medipharma Limited

Clinical • New P1 trial • Gastrointestinal Cancer • Oncology • Solid Tumor

Hutchison China MediTech Limited Reports 2020 Full Year Results and Provides Business Updates and Evolves Corporate Identity (GlobeNewswire) - “Potential upcoming clinical and regulatory milestones for HMPL-306: Initiate a Phase I dose escalation study in the U.S. in patients with relapsed or refractory hematological malignancies with an IDH1 and/or IDH2 mutation in the first half of 2021; and Initiate a Phase I dose escalation study in the U.S. in patients with solid tumors with an IDH1 and/or IDH2 mutation in the first half of 2021. Potential upcoming clinical and regulatory milestones for HMPL-295: Initiate a Phase I study in China in mid-2021; IND-enabling toxicity studies are underway for three additional in-house discovered oncology drug candidates, two small molecules and one antibody. If the outcomes of these studies are as we anticipate, we will follow with IND submissions during 2021”

IND • New P1 trial • Trial status • Hematological Malignancies • Oncology • Solid Tumor

Hutchison China MediTech Limited Reports 2020 Full Year Results and Provides Business Updates and Evolves Corporate Identity (GlobeNewswire) - "Potential upcoming clinical and regulatory milestones for HMPL-295: Initiate a Phase I study in China in mid-2021."

New P1 trial • Oncology