Evaluating OATD-02 for advanced solid tumors
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)
PHASE1 · Molecure S.A. · NCT05759923
This study is testing a new oral medication called OATD-02 to see if it can help people with advanced solid tumors, like colorectal and ovarian cancer, by making their tumors respond better to treatment.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Molecure S.A. (industry) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 3 sites (Bydgoszcz, Kuyavian-Pomeranian Voivodeship and 2 other locations) |
| Trial ID | NCT05759923 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety, tolerability, and potential anti-tumor activity of OATD-02, an oral medication, in patients with advanced or metastatic solid tumors, including colorectal, ovarian, renal, and pancreatic cancers. The study employs a Modified Bayesian Optimal Interval (BOIN) design to determine the appropriate dosing based on toxicity levels. A total of 30 patients will be enrolled, with a treatment duration of up to 6 months, to evaluate how OATD-02 may enhance tumor responses to immunotherapy by increasing arginine levels or exhibiting intrinsic anti-tumor effects.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced or metastatic colorectal, renal, pancreatic, or platinum-resistant ovarian cancers that have progressed after standard therapies.
Not a fit: Patients with clinically active central nervous system metastases or those unable to take oral medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.
How similar studies have performed: While this approach is novel, similar studies targeting advanced solid tumors have shown promise in enhancing treatment responses.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bydgoszcz, Kuyavian-Pomeranian Voivodeship and 2 other locations
- Site — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland (RECRUITING)
- Site — Otwock, Masovian Voivodeship, Poland (RECRUITING)
- SIte — Warsaw, Masovian Voivodeship, Poland (RECRUITING)
Study contacts
- Study coordinator: Clinical
- Email: clinical@molecure.com
- Phone: 0048225526724
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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