Phase I Study to Assess Safety and Antitumor Effects of Oral OATD-02 in Adults With Advanced or Metastatic Colorectal, Ovarian, Renal, or Pancreatic Cancer

What this Trial Is About

Researchers are studying OATD-02, an oral drug, to see if it is safe and can help improve tumor responses to immunotherapy by increasing arginine levels or having its own anti-tumor effects. This study focuses on participants with advanced or metastatic colorectal, ovarian, renal, or pancreatic cancers who have already tried standard cancer treatments. The trial is a phase I, open-label, dose-escalation study using a Modified Bayesian Optimal Interval design to find the best dose with manageable side effects. Participants will receive OATD-02 as a single treatment, starting at a dose of 2.5 mg once daily. The dose may be increased based on tolerance and side effects, assessed by dose-limiting toxicities. The treatment period may last up to 6 months, with up to 30 patients enrolled plus replacements if needed. The study design helps guide dose adjustments to balance safety and potential effectiveness. During the trial, participants will be monitored for side effects and safety over 6 months, including adverse events and dose-limiting toxicities. Researchers will also measure how the drug moves through the body and its anti-tumor activity, including response rates and progression-free survival. Participants will have regular assessments to evaluate these outcomes and their overall health, with the study ending in March 2027.

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