First-in-human Phase I Study to Evaluate Safety, Tolerability and Antineoplastic Activity of OATD-02 in Patients with Selected Advanced and/or Metastatic Solid Tumors Including Colorectal, Ovarian, Pancreatic, and Renal Cell Carcinoma

What this Trial Is About

Researchers are evaluating the safety and potential anti-tumor effects of OATD-02, an oral drug, in people with advanced or metastatic colorectal, ovarian, renal, or pancreatic cancers. This phase I trial aims to understand if OATD-02 can safely increase arginine levels or directly enhance tumor response to immunotherapy in these patients who have already undergone standard treatments. The study is sponsored by Molecure S.A. and uses a dose-escalation design to find the optimal dose with manageable side effects. Participants will receive OATD-02 monotherapy orally, starting at a dose of 2.5 mg once daily. Dose adjustments will be made based on observed dose-limiting toxicities using a Modified Bayesian Optimal Interval design. The treatment period can last up to six months, during which researchers will monitor safety, tolerability, and anti-tumor activity. The study plans to enroll 30 patients, with up to 10 replacements if some patients cannot be evaluated for toxicity. During the trial, participants will undergo regular assessments including monitoring of adverse events, dose-limiting toxicities, and pharmacokinetic parameters such as maximum and minimum drug concentrations. Researchers will also evaluate tumor responses like objective response rate and progression-free survival over the six-month treatment period. Safety and treatment effects will be closely watched throughout, ensuring participant well-being while gathering important data on OATD-02.

First-in-human Phase I Study to Evaluate Safety, Tolerability and Antineoplastic Activity of OATD-02 in Patients with Selected Advanced And/or Metastatic Solid Tumours