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Can a pill boost the immune system to fight Hard-to-Treat cancers?

NCT ID NCT05759923

Disease control Sponsor: Molecure S.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This early-stage trial is testing an experimental oral drug called OATD-02 in people with advanced or metastatic colorectal, ovarian, pancreatic, or renal cell cancer. The goal is to see if the drug is safe and whether it can help the immune system attack tumors by increasing arginine levels. About 40 participants will receive the drug in increasing doses to find the safest and most promising level.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OATD-02, an oral drug that may boost the immune system's ability to fight tumors by increasing arginine levels.
What this could lead to
If successful, OATD-02 could become a new treatment option for advanced solid tumors, potentially enhancing the effectiveness of immunotherapy.
What could go wrong
This is an early-phase trial with a small number of participants, so the drug may not prove safe or effective. Side effects and lack of benefit are possible.
Why investors are watching

Molecure is testing OATD-02, an oral drug, in 40 patients with advanced colorectal, ovarian, pancreatic, or renal cancer. This is a first-in-human phase 1 trial, so the main question is whether the drug is safe and shows any sign of shrinking or controlling tumors. For a micro-cap company with few other products, this readout is a major value driver.

If it works: If the drug proves safe and shows clear anti-tumor activity, Molecure could advance it to later-stage trials and attract partnership interest. A positive signal would validate the company's science and support its pipeline value.

If it fails: Phase 1 trials fail often, and this one could show safety problems or no meaningful tumor response. A negative or delayed result would likely hurt the company's prospects, since it has few other assets to fall back on.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Capable of understanding and complying with protocol requirements. 2. Male or female patient aged ≥18 years at Screening. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 4. Histologically or cytologically confirmed advanced and/or metastatic colorectal cancer, renal cell cancer, or pancreatic cancer or recurrent serous ovarian cancer (platinum-resistant/ineligible to receive platinum-based chemotherapy), that either progressed or relapsed after all relevant standard of care cancer therapies (at least 1 line of systemic cancer therapy). 5. Written informed consent given by the patient before the initiation of any study procedures. Exclusion Criteria: 1. Unable to take oral medications. 2. Clinically active central nervous system metastases and/or carcinomatous meningitis. 3. Major surgery within 30 days before the first IMP dose. 4. Pregnant or breastfeeding women. 5. Known allergy to excipients of the IMP. 6. Severe, uncontrolled systemic disease which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to participate in the study. 7. Participation in another clinical study within 4 weeks before the first IMP dose.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal carcinoma colorectal neoplasm exocrine pancreatic carcinoma kidney cancer ovarian cancer ovarian carcinoma pancreatic adenocarcinoma pancreatic neoplasm renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced colorectal carcinoma Advanced ovarian carcinoma Advanced pancreatic carcinoma Advanced renal cell carcinoma Metastatic colorectal carcinoma Metastatic ovarian carcinoma Metastatic pancreatic carcinoma Metastatic renal cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • SIte

    RECRUITING

    Warsaw, Masovian Voivodeship, 01748, Poland

  • Site

    RECRUITING

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85796, Poland

  • Site

    RECRUITING

    Otwock, Masovian Voivodeship, 05-400, Poland

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