CV6-168 / CV6 Therap - LARVOL DELTA

CV6 Therapeutics Announces Initiation of Patient Dosing in Phase 1a Clinical Trial Evaluating the Investigational First-In-Class, Specific dUTPase Inhibitor CV6-168 (GlobeNewswire) - "CV6 Therapeutics...announced the successful dosing of the second patient in its Phase 1a study evaluating CV6-168 + infusional 5-fluorouracil (5-FU) in cancer patients. This Phase 1 part of this modular, first-in-human Phase 1a clinical trial (ISRCTN12434145) is a multicenter, open-label, dose-escalation study of CV6-168 in patients with advanced metastatic solid tumors refractory to standard treatment. The primary objectives of the study are to determine the following parameters for CV6-168: safety profile, potential optimal biologically relevant doses, maximum tolerated dose, and anti-tumor activity."

Trial status • Solid Tumor

A modular, open-label, phase I/IIa study to evaluate the safety, tolerability, pharmacokinetics (PKs) and anti-tumour activity of a first-in-class (FIC) specific dUTPase inhibitor CV6-168 combined with anti-cancer treatments in patients (pts) with advanced malignancies. (ASCO 2024) - "This is a first-in-human, modular study initially investigating PK and safety of CV6-168 with bolus/infusional 5-fluorouracil (5-FU) and folinic acid (FA). This trial design 1) Allows one protocol responsive to emerging data for a compound with multiple hypotheses, supporting studies in multiple combinations, reducing time from emerging data to 'first subject in study" compared with multiple individual studies; 2) Has the potential to reduce the number of pts unnecessarily exposed to a novel agent; and 3) Allows investigators to pre-empt emerging data and changes to the treatment landscape. These challenges in oncology drug development emphasize the need for flexible designs as the landscape of drug development continually evolves."

Clinical • Metastases • P1/2 data • PK/PD data • Oncology • Solid Tumor • TYMS

CV6 Therapeutics Receives MHRA Approval for Novel Cancer Therapy Phase 1a Clinical Trial (GlobeNewswire) - "CV6 Therapeutics...announces it has received approval from the UK’s medicines regulator, the MHRA, for the company’s first-in-human Phase 1a clinical trial of its lead oncology therapeutic, CV6-168, in patients with colorectal and other cancers....The UK multi-centre Phase 1a clinical trial will combine CV6-168 with infusional 5-FU to treat gastrointestinal cancer patients, such as colon, gastric, and pancreatic cancers as well as other tumor types such as melanoma, lung, and ovarian cancers....The initial trial is for up to 50 patients, taking part at leading cancer hospitals in Belfast, Glasgow, Newcastle, and the Royal Marsden in London that are within the UK Experimental Cancer Medicine Centre (ECMC) network. The trial is expected to have dosed its first patient in Q1 2024, with trial read-outs expected in H1 2025."

New P1 trial • Colorectal Cancer • Gastric Cancer • Lung Cancer • Melanoma • Ovarian Cancer • Pancreatic Cancer