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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

Investigational Medication for Advanced Metastatic Solid Tumors: Safety and Tolerability Study

Recruiting
18 years and older
All
Phase 1

The purpose of this study is to investigate advanced metastatic colorectal cancer, ovarian cancer, renal cancer, and pancreatic cancer. This study evaluates an investigational medication administered orally to see if it is safe and can increase arginine levels or has anti-tumor activity.

The study focuses on evaluating the safety and tolerability of the investigational medication. It assesses whether the medication can restore or enhance the body's response to immunotherapy in a general way.

  • Who can participate: Participants must be 18 years or older with advanced metastatic colorectal, renal, pancreatic, or recurrent serous ovarian cancer. They must have an ECOG performance status of 0-1 and have received at least one line of systemic cancer therapy.
  • Study details: Participants will take the investigational medication orally. The study will evaluate its effects on tumor response and safety. Some participants may receive a placebo, which is an inactive substance that looks like the investigational medicine but does not contain any medicine.
  • Study timelines: The study will last up to 6 months.
Study details
    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

NCT05759923

Molecure S.A.

8 August 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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