NCT05759923RecruitingPhase 1
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
An Open-label, Multicentre, Dose-escalation, 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 (Colorectal Cancer, Ovarian Cancer, Pancreatic Cancer or Renal Cell Carcinoma)
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 9 Feb 2023
- Start date
- 26 Jan 2023
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Molecure S.A.
- NCT number
- NCT05759923
- EU CT number
- 2024-510836-31-00
- EudraCT number
- 2022-000697-25
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 40
- From 26 Jan 2023 to the primary completion date, 31 Mar 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unable to take oral medications.
- Major surgery within 30 days before the first IMP dose.
- Participation in another clinical study within 4 weeks before the first IMP dose.
Other illness
- Known allergy to excipients of the IMP.
- 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.
Other
- Clinically active central nervous system metastases and/or carcinomatous meningitis.
- Pregnant or breastfeeding women.
Who the study is looking for
- Capable of understanding and complying with protocol requirements.
- Male or female patient aged ≥18 years at Screening.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- 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).
- Written informed consent given by the patient before the initiation of any study procedures.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Recruiting |
| Europejskie Centrum Zdrowia Otwock Sp. Z.o.o. Coordinator of this site? Confirm its status | Otwock | Poland | Recruiting |
| LUX MED Onkologia Sp. z.o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.