sosimerasib (HBI-2438) / HUYA Bioscience, Jemincare - LARVOL DELTA

Phase 3 Trial of JMKX001899 Versus Docetaxel in Previously Treated Advanced or Metastatic KRAS G12C-Mutant NSCLC (clinicaltrials.gov) - P3 | N=472 | Not yet recruiting | Sponsor: Jemincare

New P3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

A Dose Escalation Study of HBI-2438 in Patients With Solid Tumors Harboring KRAS G12C Mutation (clinicaltrials.gov) - P1 | N=44 | Active, not recruiting | Sponsor: HUYABIO International, LLC. | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2025 ➔ Dec 2026 | Trial primary completion date: Aug 2025 ➔ Dec 2026

Enrollment closed • Trial completion date • Trial primary completion date • Colon Cancer • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • KRAS

A Phase Ib Study of JMKX001899 in Combination With Other Therapies in Advanced NSCLC Harboring KRAS G12C Mutation (clinicaltrials.gov) - P1 | N=72 | Recruiting | Sponsor: Jemincare | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Sosimerasib monotherapy in patients with previously treated KRAS G12C–mutated non-small cell lung cancer: Primary results of a phase 2 study. (ASCO 2025) - P1/2 | "Sosimerasib monotherapy has shown promising anti-tumor activity with manageable safety profile in locally advanced/metastatic NSCLC patients harboring KRAS G12C mutation. This study is still ongoing and longer follow-up will provide more solid evidence. Clinical trial information: ChiCTR2200059986."

Clinical • IO biomarker • Monotherapy • P2 data • Anemia • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

A Phase Ib Study of JMKX001899 in Combination With Other Therapies in Advanced NSCLC Harboring KRAS G12C Mutation (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Jemincare

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

To Assess the Effects of Single Dose of JMKX001899 on QTc Interval in Healthy Subjects (clinicaltrials.gov) - P1 | N=27 | Not yet recruiting | Sponsor: Jemincare

New P1 trial • Oncology • Solid Tumor

Therapeutic activity of a new KRAS G12C inhibitor JMKX001899 in brain metastases: Preclinical models of KRAS G12C -mutant non-small cell lung cancer. (ASCO 2024) - "Ten days after implantation, oral once-daily dosing of vehicle, sotorasib (AMG510) at 100 mg/kg, 30 mg/kg and JMKX001899 at 100 mg/kg, 30 mg/kg, 10 mg/kg was started and continued for 21 days. The preclinical models in vivo suggest the new KRAS G12C inhibitor JMKX001899 penetrates the central nervous system and show great inhibition of KRAS G12C -mutant NSCLC with BM, which demonstrates therapeutic activity of JMKX001899 in BM. These data support further development of JMKX001899 in patients with KRAS G12C -mutant NSCLC with BM."

Preclinical • Brain Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

Study to Evaluate the Drug-drug Interaction of JMKX001899 in Healthy Subjects (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Jemincare

New P1 trial • 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

A Phase 1 , Open-Label, Dose Escalation of HBI-2438 in Patients with Advanced Malignant Tumors Harboring KRAS G12C Mutation (ESMO Asia 2022) - No abstract available

Clinical • P1 data • Oncology • Solid Tumor • KRAS

Jemincare Announces the Exclusive License of the Kras Inhibitor to HUYABIO (Canada Newswire) - "Jemincare...announced today its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co., Ltd., had licensed exclusive worldwide ex-China rights to the Kras inhibitor, JMKX1899, to HUYABIO International, the leader in accelerating global development of China's pharmaceutical innovations. Jemincare will retain the relevant rights in greater China area....The parties will work closely to file IND in US FDA in 2021 to move towards clinical development."

IND • Licensing / partnership

A Dose Escalation Study of HBI-2438 in Patients With Solid Tumors Harboring KRAS G12C Mutation (clinicaltrials.gov) - P1 | N=44 | Recruiting | Sponsor: HUYABIO International, LLC. | Not yet recruiting ➔ Recruiting

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

A Dose Escalation Study of HBI-2438 in Patients With Solid Tumors Harboring KRAS G12C Mutation (clinicaltrials.gov) - P1 | N=44 | Not yet recruiting | Sponsor: HUYABIO International, LLC.

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