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

Launched by MOLECURE S.A. · Mar 7, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called OATD-02, which is taken by mouth, to see if it is safe and effective for people with advanced cancers, such as advanced ovarian, renal, pancreatic, and colorectal cancers. The main goal is to find out if OATD-02 can help improve the body's response to existing cancer treatments by increasing levels of a substance called arginine that may aid in fighting tumors. The trial is currently looking for participants who are at least 18 years old, have been diagnosed with one of the specific cancer types, and have already received at least one standard treatment that did not work for them.

Participants in this study can expect to undergo regular monitoring to assess their health and response to the treatment. To qualify for the trial, individuals must be able to take oral medications and have a good overall health status, meaning they can carry out daily activities with little to no limitation. However, those with certain conditions, like severe uncontrolled diseases or recent major surgeries, may not be eligible. It's important for interested individuals to understand the requirements and discuss their options with their healthcare provider before considering participation in this trial.

Gender

ALL

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.