First-in-human study of OATD-02 in advanced solid tumours
Tests the new drug OATD-02 in adults with advanced colorectal, ovarian, pancreatic or kidney cancer.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Bydgoszcz, Otwock, and Warsaw, PolandSee the 3 sites
- Phase
- Phase 1
Where in Poland
- Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W BydgoszczyBydgoszcz, PolandTaking people
- Europejskie Centrum Zdrowia Otwock Sp. Z.o.o.Otwock, PolandTaking people
- LUX MED Onkologia Sp. z.o.o.Warsaw, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Molecure S.A.
- Trial code
- NCT05759923EU 2024-510836-31-00
- Record updated
- 31 July 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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.
Exclusion: 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; 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; Clinically active central nervous system metastases and/or carcinomatous meningitis; Pregnant or breastfeeding women.