Clinical trial · Interventional
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
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Colorectal Carcinoma | Colorectal Carcinoma | CURATED_BROADER | 0.78 |
| Advanced Ovarian Carcinoma | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
| Advanced Pancreatic Carcinoma | Pancreatic Carcinoma | CURATED_BROADER | 0.78 |
| Advanced Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Metastatic Colorectal Carcinoma | Colorectal Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Ovarian Carcinoma | Ovarian Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Pancreatic Carcinoma | Pancreatic Carcinoma | CURATED_BROADER |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OATD-02 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OATD-02
- interventionNames
- Drug: OATD-02
Primary outcomes (2)
- measure
- Nature, frequency and severity of adverse events (AEs)
- timeFrame
- 6 months
- measure
- Occurence of DLTs
- timeFrame
- 6 months
Secondary outcomes (5)
- measure
- PK parameters for OATD-02: CMax
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available