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

Inclusion 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 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 criteria

• 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.