GEC-255 / GenEros - LARVOL DELTA

Phase 1 study evaluating the safety, tolerability, pharmacokinetics (PK), and efficacy of GEC255, a novel KRASG12C inhibitor, in advanced solid tumors. (ASCO 2023) - "GEC255 has been well tolerated at the doses tested and has shown encouraging anticancer activity to advanced NSCLC patients with KRASG12C mutation pts. MTD has not been determined, and enrollment into the dose exploration is ongoing. (http://www.chinadrugtrials.org.cn/index.html)."

Clinical • Metastases • P1 data • PK/PD data • Anemia • Colorectal Cancer • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

GenEros to Present Promising Results of GEC255 Phase I Clinical Trial for Advanced NSCLC Patients with KRAS G12C Mutation (PRNewswire) - P1 | N=70 | NCT05768321 | Sponsor: GenEros Biopharma Hangzhou Ltd. | "GenEros Biopharma...will unveil the preliminary data from the phase I clinical trial of GEC255, a unique KRAS G12C inhibitor, at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. As of the data cutoff date of February 3, 2023, preliminary data from the study (NCT05768321) sponsored by GenEros Biopharma demonstrated encouraging results. Sixteen NSCLC patients with the KRAS G12C mutation were enrolled in the Phase I dose escalation, followed by dose expansion in selected doses....Tumor response was evaluated in 13 subjects at least once. Among them, 10 subjects (76.9%) achieved objective responses (complete or partial response), while 12 subjects (92.3%) demonstrated disease control (objective response or stable disease). In the 600mg dose group, the objective response rate (ORR) was 83.3%, and the disease control rate (DCR) was 100% (n=6)."

P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Study of GEC255 in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: GenEros Biopharma Hangzhou Ltd

Metastases • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KEAP1 • KRAS • STK11