RecruitingPhase 1NCT05759923

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)


Sponsor

Molecure S.A.

Enrollment

40 participants

Start Date

Jan 26, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human Phase I trial testing the safety of a new experimental drug called OATD-02 in people with certain advanced or metastatic solid cancers — specifically colorectal, kidney, or pancreatic cancer, or platinum-resistant ovarian cancer — that have not responded to standard treatments. **You may be eligible if...** - You are 18 or older - You have confirmed advanced or metastatic colorectal, kidney, pancreatic cancer, or recurrent platinum-resistant ovarian cancer - You have tried at least 1 prior standard treatment regimen that did not work - Your general health is good enough to function well (ECOG 0–1) **You may NOT be eligible if...** - You have untreated brain metastases - You have active autoimmune disease or are taking immune-suppressing medications - You have had major surgery or radiation in the last 4 weeks - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOATD-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


Locations(3)

Site

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Site

Otwock, Masovian Voivodeship, Poland

SIte

Warsaw, Masovian Voivodeship, Poland

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NCT05759923


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