KC1036 / Konruns Pharma - LARVOL DELTA

KC1036 in ewing sarcoma: mechanistic insights and future directions for a multi-targeted therapeutic strategy. (PubMed, Angiogenesis) - "The primary challenges ahead lie in delineating its molecular mechanisms of action beyond angiogenesis, prospectively defining resistance pathways to guide combination therapies, and rigorously evaluating its safety profile to ensure successful clinical translation. This letter outlines these priorities to stimulate further research."

Journal • Review • Ewing Sarcoma • Oncology • Sarcoma • Solid Tumor • EWSR1 • FLI1

KC1036, a multi-kinase inhibitor with anti-angiogenic activity, can effectively suppress the tumor growth of Ewing sarcoma. (PubMed, Angiogenesis) - "The novel anti-angiogenic inhibitor, KC1036, is effective in treating ES in the preclinical models."

Journal • Ewing Sarcoma • Oncology • Sarcoma • Solid Tumor • AXL • CAFs • FGFR • FLT1 • KDR • NPY1R

To Evaluate KC1036 in the Patients with Advanced Digestive System Tumors (clinicaltrials.gov) - P1/2 | N=133 | Recruiting | Sponsor: Beijing Konruns Pharmaceutical Co., Ltd. | Trial completion date: Apr 2025 ➔ Dec 2025 | Trial primary completion date: Apr 2024 ➔ Oct 2025

Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Oncology

A Study of KC1036 in Patients with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=207 | Recruiting | Sponsor: Beijing Konruns Pharmaceutical Co., Ltd. | Trial completion date: Jul 2024 ➔ Dec 2025 | Trial primary completion date: Jul 2023 ➔ Oct 2025

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

A Study of KC1036 in Adolescents With Advanced Ewing Sarcoma (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Beijing Konruns Pharmaceutical Co., Ltd.

Metastases • New P2 trial • Ewing Sarcoma • Oncology • Sarcoma • Solid Tumor

A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer (clinicaltrials.gov) - P3 | N=490 | Recruiting | Sponsor: Beijing Konruns Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology • Squamous Cell Carcinoma

A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer (clinicaltrials.gov) - P3 | N=490 | Not yet recruiting | Sponsor: Beijing Konruns Pharmaceutical Co., Ltd.

Metastases • New P3 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology • Squamous Cell Carcinoma

Kangchen Pharmaceutical Co., Ltd. (603590.SH): KC1036 combined with PD-1 antibody for first-line maintenance treatment of locally advanced or metastatic esophageal squamous cell carcinoma was approved for clinical trial [Google translation] (Investing.com) - "...Kangchen Pharmaceutical (603590.SH) announced that recently, the company received the 'Clinical Trial Notice' of 'KC1036 combined with PD-1 antibody first-line maintenance therapy for locally advanced or metastatic esophageal squamous cell carcinoma' issued by the State Drug Administration."

New trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor

Kangchen Pharmaceutical: KC1036 obtained clinical trial approval notice for pediatric drugs [Google translation] (jrj.com) - "Kangchen Pharmaceutical announced that the company received the 'Drug Clinical Trial Approval Notice' for 'KC1036 for the treatment of advanced Ewing sarcoma in adolescents aged 12 years and above' approved and issued by the National Medical Products Administration, and will carry out clinical trials in the near future."

New trial • Ewing Sarcoma • Oncology • Sarcoma • Solid Tumor

Establishment and characterization of a novel lung adenocarcinoma cell line HX-JCJ harboring MET ex14 skipping mutation (ESMO 2023) - "Results Drug screen showed that this cell line was extremely sensitive to KC1036 (IC50=4.8nm), which is a home-made small molecule inhibitor with strong anti-MET and anti-angiogensis activity. Conclusions In conclusion, we successfully established a novel NSCLC cell line (HX-JCJ) harboring MET ex14 skipping mutation from the primary tumor tissue, which may provide a promising cell model for further MET relevant research."

Preclinical • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

A Food Effect Study of KC1036 in Healthy Subjects (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Beijing Konruns Pharmaceutical Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion

Kangchen Pharmaceutical: KC1036 pediatric drug clinical trial application accepted [Google translation] (163.com) - "Kangchen Pharmaceutical...announced that the company has received a clinical trial acceptance notice for the Class 1 innovative chemical drug KC1036 tablets for children approved and issued by the State Food and Drug Administration."

New trial • Lung Cancer • Oncology • Solid Tumor • Thymus Cancer

Announcement of Beijing Kangchen Pharmaceutical Co., Ltd. on KC1036 obtaining special funds for the development of high-tech industries [Google translation] (Shanghai Securities News) - "The company's KC1036 under research has received 5 million yuan in high-tech industry development funds issued by the Beijing Municipal Bureau of Economy and Information Technology...The company's KC1036 is a class 1 chemical drug under research and has entered the clinical phase II, which meets the declaration requirements for the first trial production award of innovative pharmaceutical varieties in the 'Guidelines', so it was awarded the development fund...At present, the company is actively promoting the clinical research of KC1036, and will disclose the follow-up progress in a timely manner as required."

Financing • Oncology • Solid Tumor

KC1036, a novel oral multi-kinase inhibitor, in patients with previously treated advanced esophageal squamous cell carcinoma (ESCC): Results from a multicenter, single-arm phase II trial. (ASCO 2023) - P1/2 | "KC1036 showed a manageable safety profile and promising anti-tumor activity in patients with previously treated advanced ESCC. This study is ongoing with further investigation of KC1036 in ESCC patients. Clinical trial information: NCT05260385."

Clinical • Metastases • P2 data • Cardiovascular • Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastrointestinal Disorder • Hypertension • Oncology • Squamous Cell Carcinoma • KDR

First-in-human, phase I study of KC1036, a multiple kinase inhibitor, as a single agent in patients with advanced solid tumors. (ASCO 2023) - P1 | "KC1036 demonstrated a manageable safety profile and preliminary antitumor activity in pts with advanced solid tumors. Taking safety, efficacy and clinical PK into consideration, 60 mg QD was recommended as RP2D for Part C, and this part was ongoing. Further studies in pts with lung adenocarcinoma would be considered promising."

Clinical • Metastases • P1 data • Cardiovascular • Colorectal Cancer • Esophageal Cancer • Gastrointestinal Cancer • Hypertension • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of KC1036 in Patients With Advanced Thymic Tumors (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Beijing Konruns Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Solid Tumor • Thymus Cancer

Konruns Pharma's Clinical Trial of New Tumor Drug Progresses (Market Screener) - "Beijing Konruns Pharmaceutical...has made progress in the clinical trial of its new tumor drug, according to a filing on Wednesday. The Chinese drugmaker will start the second phase of the clinical trial of its KC1036 treatment for patients with advanced thymus tumors. The company has yet to enroll subjects for the phase II trial."

Trial status • Oncology • Thymic Carcinoma • Thymus Cancer

Konruns Pharma Gets Nod to Advance Clinical Trial of Lung Cancer Drug (Market Screener) - "Beijing Konruns Pharmaceutical...has won approval to carry out the phase II clinical trial of its lung cancer drug candidate, the company said Friday. The clinical trial will assess the efficacy and safety of the Chinese drugmaker’s KC1036 therapy against advanced lung adenocarcinoma. The approval was handed down by China’s National Medical Products Administration."

New P2 trial • Lung Cancer • Oncology

A Study of KC1036 in Patients With Advanced Thymic Tumors (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Beijing Konruns Pharmaceutical Co., Ltd.

Metastases • New P2 trial • Oncology • Solid Tumor • Thymus Cancer

A Study of KC1036 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=207 | Recruiting | Sponsor: Beijing Konruns Pharmaceutical Co., Ltd. | Trial completion date: Jul 2023 ➔ Jul 2024 | Trial primary completion date: Jul 2022 ➔ Jul 2023

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

To Evaluate KC1036 in the Patients With Advanced Digestive System Tumors (clinicaltrials.gov) - P1/2 | N=133 | Recruiting | Sponsor: Beijing Konruns Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting | Initiation date: Apr 2022 ➔ Jan 2022

Enrollment open • Metastases • Trial initiation date • Gastrointestinal Cancer • Oncology

To Evaluate KC1036 in the Patients With Advanced Digestive System Tumors (clinicaltrials.gov) - P1/2 | N=133 | Not yet recruiting | Sponsor: Beijing Konruns Pharmaceutical Co., Ltd.

New P1/2 trial • Gastrointestinal Cancer • Oncology

A Food Effect Study of KC1036 in Healthy Subjects (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Beijing Konruns Pharmaceutical Co., Ltd.

New P1 trial

A Study of KC1036 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=207; Recruiting; Sponsor: Beijing Konruns Pharmaceutical Co., Ltd.; N=108 ➔ 207

Clinical • Enrollment change • Oncology • Solid Tumor

A Study of KC1036 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=108; Recruiting; Sponsor: Beijing Konruns Pharmaceutical Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Oncology • Solid Tumor