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Tests treatment safety and results for Advanced Ovarian Carcinoma
Official 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
ClinicalTrials.gov ID: NCT05759923
What this study is testing
What is OATD-02?
OATD-02 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced ovarian carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Written informed consent given by the patient before the initiation of any study procedures.
You likely can't join if
- Unable to take oral medications.
- Clinically active central nervous system metastases and/or carcinomatous meningitis.
- Major surgery within 30 days before the first IMP dose.
- Pregnant or breastfeeding women.
- 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...
See the full eligibility criteria
- 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...
- Written informed consent given by the patient before the initiation of any study procedures.
- Unable to take oral medications.
- Clinically active central nervous system metastases and/or carcinomatous meningitis.
- Major surgery within 30 days before the first IMP dose.
- Pregnant or breastfeeding women.
- 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.
- Participation in another clinical study within 4 weeks before the first IMP dose.
The study team makes the final eligibility decision.
Where it's taking place
- Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
- Otwock, Masovian Voivodeship, Poland
- Warsaw, Masovian Voivodeship, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland; Otwock, Masovian Voivodeship, Poland; Warsaw, Masovian Voivodeship, Poland. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.