NCT05759923 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
| NCT ID | NCT05759923 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Molecure S.A. |
| Condition | Advanced Ovarian Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-01-26 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2023-01-26 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if the OATD-02 administration (orally) in monotherapy is safe and has the pharmacodynamic potential to restore and enhance tumour responses to immunotherapy through increased arginine levels or intrinsic anti-tumour activity in participants with advanced metastatic colorectal cancer, ovarian cancer, renal cancer or pancreatic cancer.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05759923 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Ovarian Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05759923 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05759923 currently recruiting?
Yes, NCT05759923 is actively recruiting participants. Contact the research team at clinical@molecure.com for enrollment information.
Where is the NCT05759923 trial being conducted?
This trial is being conducted at Bydgoszcz, Poland, Otwock, Poland, Warsaw, Poland.
Who is sponsoring the NCT05759923 clinical trial?
NCT05759923 is sponsored by Molecure S.A.. The trial plans to enroll 40 participants.