NCT05759923

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Molecure S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

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

Type	Name	Description
DRUG	OATD-02	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

Timeline

• Start date: 2023-01-26
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-03-08
• Last updated: 2025-02-24

Locations

3 sites across 1 country: Poland