Evaluating OATD-02 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety, tolerability, and potential anti-tumor activity of OATD-02, an oral medication, in patients with advanced or metastatic solid tumors, including colorectal, ovarian, renal, and pancreatic cancers. The study employs a Modified Bayesian Optimal Interval (BOIN) design to determine the appropriate dosing based on toxicity levels. A total of 30 patients will be enrolled, with a treatment duration of up to 6 months, to evaluate how OATD-02 may enhance tumor responses to immunotherapy by increasing arginine levels or exhibiting intrinsic anti-tumor effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Capable of understanding and complying with protocol requirements.
2. Male or female patient aged ≥18 years at Screening.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Histologically or cytologically confirmed advanced and/or metastatic colorectal cancer, renal cell cancer, or pancreatic cancer or recurrent serous ovarian cancer (platinum-resistant/ineligible to receive platinum-based chemotherapy), that either progressed or relapsed after all relevant standard of care cancer therapies (at least 1 line of systemic cancer therapy).
5. Written informed consent given by the patient before the initiation of any study procedures.

Exclusion Criteria:

1. Unable to take oral medications.
2. Clinically active central nervous system metastases and/or carcinomatous meningitis.
3. Major surgery within 30 days before the first IMP dose.
4. Pregnant or breastfeeding women.
5. Known allergy to excipients of the IMP.
6. Severe, uncontrolled systemic disease which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to participate in the study.
7. Participation in another clinical study within 4 weeks before the first IMP dose.

Where it's running

• Site
  Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland Recruiting
• Site
  Otwock, Masovian Voivodeship, Poland Recruiting
• SIte
  Warsaw, Masovian Voivodeship, Poland Recruiting

Study contacts

• Study coordinator: Clinical
• Email: clinical@molecure.com
• Phone: 0048225526724

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.