ASKC202 / Aosaikang Pharma - LARVOL DELTA

ASKC202 Combined With Limertinib Versus Platinum-based Chemotherapy in Treatment of Locally Advanced or Metastatic NSCLC With MET Amplification/Overexpression After Failure of EGFR-TKI Therapy (clinicaltrials.gov) - P3 | N=286 | Recruiting | Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

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

ASKC202 Combined With Limertinib Versus Platinum-based Chemotherapy in Treatment of Locally Advanced or Metastatic NSCLC With MET Amplification/Overexpression After Failure of EGFR-TKI Therapy (clinicaltrials.gov) - P3 | N=286 | Not yet recruiting | Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.

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

Phase I dose escalation of ASKC202, a novel cMET tyrosine kinase inhibitor, in patients with advanced solid tumors (AACR 2024) - P1 | "One subject (150mg QD) with MET missense mutation (p.S186L) had a 67% tumor reduction in intracranial lesion from baseline. Exposure of ASKC202 increased dose-proportionally at dose range 50mg to 300mg, but less than dose-proportionally increased at 300mg to 600mg.Conclusions ASKC202 monotherapy was well-tolerated with manageable safety profile and showed anti-tumor signal and the central nervous system efficacy."

Clinical • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

ASKC202-001: Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of ASKC202 With or Without ASK120067 (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd. | Trial completion date: May 2025 ➔ Dec 2027 | Trial primary completion date: May 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Oncology • Solid Tumor • MET

ASKC202 plus limertinib in EGFR-mutated advanced or metastatic NSCLC patients with MET amplification or MET overexpression following EGFR-TKI (ESMO 2025) - P1 | "Conclusions ASKC202 plus Limertinib showed excellent antitumor activity and a manageable safety profile in patients with EGFRm NSCLC with MET amplification or MET overexpression who have progressed after EGFR TKI therapy. Legal entity responsible for the study Jiangsu Aosaikang Pharmaceutical Co., Ltd, Jiangsu, China."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Aosaikang: The combination of ASKC202 tablets and ASK120067 tablets has been approved for clinical trials [Google translation] (Stockstar) - "Securities Times e company news, Aosaikang...announced on the evening of November 12 that the clinical trial of the combination of ASKC202 tablets and ASK120067 tablets submitted by Jiangsu Aosaikang Pharmaceutical, a wholly-owned subsidiary of the company, has recently received a clinical trial certificate issued by the State Food and Drug Administration. The trial approval notice agrees to conduct a clinical trial of ASKC202 tablets in combination with ASK120067 tablets for advanced solid tumors."

New trial • Oncology • Solid Tumor

Aosaikang: Subsidiary drug clinical trial application accepted [Google translation] (Daily Economic News - NBD) - "...Aosaikang announced that the clinical trial application for the combination of the subsidiary's innovative drug ASKC202 tablets and ASK120067 tablets has been accepted."

New trial • Oncology

Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of ASKC202 (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: May 2022 ➔ Aug 2022

Enrollment open • Metastases • Trial initiation date • Gastrointestinal Cancer • Oncology • Solid Tumor • MET

Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of ASKC202 (clinicaltrials.gov) - P1 | N=150 | Not yet recruiting | Sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.

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