Actively Recruiting
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
Led by Molecure S.A. · Updated on 2025-02-24
40
Participants Needed
3
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and follow study requirements
- Male or female aged 18 years or older
- ECOG performance status of 0 or 1
- Confirmed advanced or metastatic colorectal, renal, pancreatic cancer, or recurrent serous ovarian cancer that is platinum-resistant or ineligible for platinum chemotherapy
- Cancer progressed or relapsed after at least one prior systemic cancer therapy
- Provided written informed consent before starting any study procedures
You will not qualify if you...
- Unable to take oral medications
- Active central nervous system metastases or carcinomatous meningitis
- Major surgery within 30 days before first study drug dose
- Pregnant or breastfeeding women
- Known allergy to components of the study drug
- Severe uncontrolled systemic disease that could affect safety or study participation
- Participation in another clinical study within 4 weeks before first study drug dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Site
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85796
Actively Recruiting
2
Site
Otwock, Masovian Voivodeship, Poland, 05-400
Actively Recruiting
3
SIte
Warsaw, Masovian Voivodeship, Poland, 01748
Actively Recruiting
Research Team
C
Clinical
CONTACT
M
Molecure SA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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