SC0245 / WuXi AppTec, Shijiazhuang Sagacity, Wuxi Biocity - LARVOL DELTA

An open-label, multicenter, phase Ib/II study of the ATR inhibitor SC0245 in combination with irinotecan in patients with relapsed and refractory extensive stage small cell lung cancer (ES-SCLC). (ASCO 2024) - P1/2 | "Among the 9 pts who were evaluable for tumor response, one confirmed partial response (PR) was reported in a pt with ES-SCLC (progressed on prior 1 st line of etoposide + carboplatin + serplulimab treatment) treated in the 120mg QD dose cohort, and the response sustained for 32+ weeks; five pts (5/9, 55.6%) had stable disease (SD) as their best response. SC0245 exhibited favorable safety and PK characteristics when administered in combination with IRI at doses ranging from 80mg QD to 120mg BID and the regimen has demonstrated preliminary antitumor activity in ES-SCLC, supporting further evaluation of the regimen in ES-SCLC and other relevant malignancies."

Clinical • Combination therapy • P1/2 data • Ataxia • Febrile Neutropenia • Hematological Disorders • Immunology • Leukopenia • Lung Cancer • Movement Disorders • Neutropenia • Oncology • Primary Immunodeficiency • Small Cell Lung Cancer • Solid Tumor

An open-label, single-arm, dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of the ATR inhibitor SC0245 in advanced solid malignancies. (ASCO 2024) - "SC0245 exhibited favorable safety and PK characteristics when administered intermittently at doses up to 200mg BID in pts with advanced solid cancers. SC0245 appeared to induce less hematological toxicity than other ATR inhibitors at relevant doses. Based on these preliminary data, SC0245 will be developed in combination with other anti-tumor agents that may have synergies with ATR inhibitors such as topoisomerase 1 inhibitors and DNA damaging agents."

Clinical • Metastases • PK/PD data • Anemia • Ataxia • Constipation • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Leukopenia • Movement Disorders • Oncology • Primary Immunodeficiency • Solid Tumor • Thrombocytopenia

SC0245 and Irinotecan in Treating Patients With Relapsed Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (clinicaltrials.gov) - P1/2 | N=67 | Recruiting | Sponsor: Biocity Biopharmaceutics Co., Ltd. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

SC0245 and Irinotecan in Treating Patients With Relapsed Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (clinicaltrials.gov) - P1/2 | N=67 | Not yet recruiting | Sponsor: Biocity Biopharmaceutics Co., Ltd.

Combination therapy • New P1/2 trial • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor

[VIRTUAL] Preclinical evaluation of SC0245, a small molecule inhibitor of ATR kinase. (ASCO 2020) - "Moreover, in the SNU601 and LoVo CDX mouse models, SC0245 oral administration significantly inhibited tumor growth, with better efficacy than AZD6738. SC0245, a novel potent ATR kinase inhibitor, has marked antitumor efficacy in the ATM pathway or ARID1A deficient solid tumor animal models, and has outstanding PK properties. SC0245 represents a promising clinical candidate for treating solid cancers, such as gastric and colorectal cancers. Research Funding: Sagacity"

Preclinical • Ataxia • Colorectal Adenocarcinoma • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Movement Disorders • Oncology • Primary Immunodeficiency • Solid Tumor • ARID1A • CHEK1