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
Advanced Ovarian Carcinoma, Advanced Renal Cell Carcinoma, Advanced Pancreatic Carcinoma
About this trial
This is an interventional treatment trial for Advanced Ovarian Carcinoma focused on measuring solid tumors, renal cancer, ovarian cancer, pancreatic cancer, colorectal cancer
Eligibility Criteria
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.
Sites / Locations
- SiteRecruiting
- SiteRecruiting
- SIteRecruiting
Arms of the Study
Arm 1
Experimental
OATD-02