HBI-2376 / HUYA Bioscience, Genhouse Bio - LARVOL DELTA

Initial results from a phase I study of the SHP2 inhibitor GH21 as monotherapy in patients with advanced solid tumors. (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT05183243 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Metastases • Monotherapy • P1 data • Oncology • Solid Tumor

A Study of GH21 Combined With Previous Target Therapy or Immunotherapy in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=72 | Recruiting | Sponsor: Suzhou Genhouse Bio Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

GH21 Combined With D-1553 With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=126 | Not yet recruiting | Sponsor: Suzhou Genhouse Bio Co., Ltd.

Metastases • New P1/2 trial • Oncology • Solid Tumor • KRAS

Qinhao Pharmaceutical and AstraZeneca reach clinical research cooperation [Google translation] (163.com) - "On April 9, Qinhao Pharmaceutical announced the establishment of a clinical research collaboration with AstraZeneca. The two parties will explore the clinical efficacy of the SHP2 inhibitor GH21 combined with osimertinib mesylate in the treatment of non-small cell lung cancer (NSCLC). It is reported that this study is an open-label, multi-center, phase 1b/2 study, aiming to evaluate the safety and tolerability of oral administration of combination therapy in patients with advanced NSCLC with epidermal growth factor receptor (EGFR) mutations., pharmacokinetics and preliminary effectiveness. The first patient has recently completed the first dose."

Licensing / partnership • Trial status • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Dose Finding Study of GH21 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=68 | Recruiting | Sponsor: Suzhou Genhouse Bio Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial primary completion date: Feb 2024 ➔ Dec 2024

Enrollment open • Metastases • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

A Study of GH21 Combined With Previous Target Therapy or Immunotherapy in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P2 | N=72 | Not yet recruiting | Sponsor: Suzhou Genhouse Bio Co., Ltd.

Metastases • New P2 trial • Oncology • Solid Tumor

A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC (clinicaltrials.gov) - P1/2 | N=94 | Recruiting | Sponsor: Suzhou Genhouse Bio Co., Ltd.

Metastases • New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

HBI-2438, HUYABIO selective KRASG12C inhibitor with BBB penetration, inhibited tumor growth in a metastatic brain model as single agent and also displayed synergy in combination with HBI-2376 (HUYABIO SHP2 inhibitor) in a CRC PDX model. (AACR-NCI-EORTC 2023) - No abstract available

Combination therapy • Metastases • Oncology • KRAS

HBI-2376, HUYABIO clinical stage SHP2 inhibitor, displays efficacy signal in patients with KRAS mutations in early clinical studies. (AACR-NCI-EORTC 2023) - No abstract available

Clinical • Oncology • KRAS

A Phase 1, Open-Label, Dose Escalation of HBI-2376 in Patients with Advanced Malignant Solid Tumors Harboring KRAS or EGFR Mutations (ESMO Asia 2022) - No abstract available

Clinical • P1 data • Oncology • Solid Tumor • EGFR • KRAS

A Dose Escalation Study of SHP2 Inhibitor in Patients With Solid Tumors Harboring KRAS of EGFR Mutations (clinicaltrials.gov) - P1; N=42; Recruiting; Sponsor: HUYABIO International, LLC.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • EGFR • KRAS

HBI-2376, HUYABIO clinical stage SHP2 inhibitor, possess robust in vitro potency and in vivo efficacy in several preclinical tumor models carrying KrasG12C or EGFR mutations (AACR 2022) - "Consistently, HBI-2376 found to be more efficacious in tumor growth inhibition than TNO-155 and RMC-4550 in NCI-H1975L858R_T790M_C797S osimertinib-resistant cell line and other tumor models. Furthermore, Western blotting showed inhibition of p-ERK and DUSP6 in HBI-2376 treated cells indicative of a biomarker of response to the therapy. These findings, along with a positive safety profile led to HBI-2376 IND clearance by FDA and suggested promising responses in NSCLC or CRC patients in the forthcoming clinical studies."

IO biomarker • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • DUSP6 • EGFR • KRAS

A Dose Escalation Study of SHP2 Inhibitor in Patients With Solid Tumors Harboring KRAS of EGFR Mutations (clinicaltrials.gov) - P1; N=42; Not yet recruiting; Sponsor: HUYABIO International, LLC.

Clinical • New P1 trial • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • EGFR • KRAS

HUYABIO Announces FDA Clearance to Initiate a Phase 1 Trial of SHP2 Inhibitor in Patients with KRAS and EGFR Mutated Tumors (PRNewswire) - "HUYABIO International...announced...the FDA clearance of HBI-2376 as an Investigational New Drug, or IND, for a Phase 1 study. The authorization to proceed enables the first testing in patients for whom this novel SHP2 inhibitor might show clinical benefit....The HUYABIO-sponsored Phase 1 trial is an open-label dose escalation study using the Company's SHP2 inhibitor to measure the safety and tolerability in patients with solid tumors harboring KRAS or EGFR mutations."

IND • Oncology • Solid Tumor

HUYABIO Files an Investigational New Drug Application with the FDA for the Novel SHP2 Inhibitor HBI-2376 (PRNewswire) - “HUYABIO International…announced today the filing of an investigational new drug application (IND) with the FDA for HBI-2376 along with Genhouse who has filed an IND with the Chinese Center for Drug Excellence CDE....The companies entered into a licensing agreement granting HUYABIO worldwide rights outside China to HBI-2376 prior to filing the regulatory submissions.”

IND • Non-US regulatory • Oncology