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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OATD-02 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OATD-02 | Drug | Boin Design Scheme will be applied for dose escalation. Dose will start with 2.5mg o.d., the desicion about dose escalations will be made based on the occurence of DLT |
| Measure | Description | Time Frame |
|---|---|---|
| Nature, frequency and severity of adverse events (AEs) | 6 months | |
| Occurence of DLTs | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical | Contact | 0048225526724 | clinical@molecure.com | |
| Molecure SA | Contact | 0048225526724 | contact@molecure.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site | Recruiting | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85796 | Poland | |
| Site |
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| PK parameter: Tmax | 6 months |
| PK parameter Cmin | 6 months |
| PK parameter: AUCO-24 | 6 months |
| Recruiting |
| Otwock |
| Masovian Voivodeship |
| 05-400 |
| Poland |
| SIte | Recruiting | Warsaw | Masovian Voivodeship | 01748 | Poland |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D015179 | Colorectal Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D010051 | Ovarian Neoplasms |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
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