An Open-label, Multicentre, Dose-escalation, 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 (Colorectal Cancer, Ovarian Cancer, Pancreatic Cancer or Renal Cell Carcinoma)

Trial ID: NCT05759923

Interventional - Phase 1 - Recruiting

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

• Advanced Ovarian Carcinoma
• Advanced Renal Cell Carcinoma
• Advanced Pancreatic Carcinoma
• Advanced Colorectal Carcinoma
• Metastatic Pancreatic Carcinoma
• Metastatic Colorectal Carcinoma
• Metastatic Renal Cell Carcinoma
• Metastatic Ovarian Carcinoma

Interventions

• OATD-02

Eligibility

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.

Sponsor

Molecure S.A.

Source: ClinicalTrials.gov

Search more clinical trials on myTomorrows