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2023-01-26
2025-12
2025-12
40
NCT05759923
Molecure S.A.
Molecure S.A.
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
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.
In this study, subjects suitable for enrollment will be identified by the investigators involved in the study. These subjects will be identified through contact with these investigators and referred for enrollment per protocol. This protocol will include determining enrollment suitability based on inclusion and exclusion criteria. Study scheme is based on Modified Bayesian Optimal Interval (BOIN) design. The BOIN design works by partitioning the probability of toxicity into a set of intervals. This design makes dose-selection decisions determined by the interval in which the probability of toxicity for the current dose is believed to reside. BOIN seeks a dose with probability of toxicity close to some pre-specified target level. Total number of patients will be 30 (plus 10 replacements if Dose Limiting Toxicity (DLT) is not evaluable). Study treatment will be up to 6 months.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-02-09 | N/A | 2025-02-20 |
2023-03-07 | N/A | 2025-02-24 |
2023-03-08 | N/A | 2024-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: OATD-02 | DRUG: OATD-02
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Nature, frequency and severity of adverse events (AEs) | 6 months | |
| Occurence of DLTs | 6 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| PK parameters for OATD-02: CMax | 6 months | |
| Anti-tumour activity parameters (Objective Response Rate (ORR), Duration of Response (DoR), PFS (Progression Free Survival) followed up to the End of Study Visit | 6 months | |
| PK parameter: Tmax | 6 months | |
| PK parameter Cmin | 6 months | |
| PK parameter: AUCO-24 | 6 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Clinical Phone Number: 0048225526724 Email: clinical@molecure.com |
Study Contact Backup Name: Molecure SA Phone Number: 0048225526724 Email: contact@molecure.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
