C019199 / Fujian Haixi New Pharmaceutical - LARVOL DELTA

A phase II study of C019199 in combination with sintilimab in patients with locally recurrent or metastatic triple negative breast cancer (TNBC). (ASCO 2025) - P1/2 | "The combination of C019199 and Sintilimab has shown promising anti-tumor activity in pts of locally recurrent or metastatic triple-negative breast cancer. The most majority of pts had experienced tumor shrinkage in target lesions from baseline. Also a good overall safety and tolerability in pts were observed."

Clinical • Combination therapy • Metastases • P2 data • Breast Cancer • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • Triple Negative Breast Cancer • CSF1R • KDR

Phase Ib trial of C019199, an oral TME modulator targeting CSF-1R/DDRs/VEGFR2, in relapsed or refractory osteosarcoma. (ASCO 2025) - P | "The data has demonstrated that C019199 exhibited a promising anti-tumor activity in patients of relapsed or refractory osteosarcoma. Combined with the encouraging tolerability and safety data, it suggests that C019199 has the potential to effectively benefit survival and improve quality of life for patients of this indication. The Phase Ib study is concluding, and a Phase III study is planned."

P1 data • Cardiovascular • Hematological Disorders • Hypertension • Leukopenia • Neutropenia • Oncology • Osteosarcoma • Pulmonary Disease • Sarcoma • Solid Tumor • Thrombocytopenia • CSF1R • KDR

A phase I/II study of C019199 in combination with sintilimab in advanced malignancy. (ASCO 2024) - P1/2 | "The combination of C019199 and Sintilimab has shown good overall safety and tolerability. No DLT was observed in the dose range of 100 mg/qd ~ 300 mg/qd. Preliminary anti-tumor activity was observed in patients with advanced solid tumors."

Combination therapy • Metastases • P1/2 data • Breast Cancer • Cardiovascular • Cervical Cancer • Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • Hypertension • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Renal Disease • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • CSF1R

Assessment of the Safety and Efficacy of C019199 Plus Sintilimab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=155 | Recruiting | Sponsor: Fujian Haixi Pharmaceuticals Co., Ltd.

Combination therapy • Metastases • New P1/2 trial • Oncology • Solid Tumor

Phase 1 study of C019199, an oral CSF-1R/DDRs/VEGFR2 multiple kinase inhibitor, to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with advanced solid tumors, including tenosynovial giant cell tumor. (ASCO 2022) - "Secondary endpoints will include pharmacokinetics, objective response rate, progression-free survival, and disease control rate. Exploratory biomarker analyses include CSF-1 and VEGF."

Clinical • IO biomarker • P1 data • PK/PD data • Giant Cell Tumor of Bone • Immune Modulation • Immunology • Inflammation • Oncology • Solid Tumor • Tenosynovial Giant Cell Tumor • CSF1R • DDR1 • KDR