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New cancer drug EXS74539 enters first human trials

NCT ID NCT07517198

Disease control Sponsor: Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial is testing an experimental oral drug called EXS74539 (REC-4539) in about 40 people with various solid tumors, including lung, prostate, ovarian, and breast cancers. The main goal is to check the drug's safety, find the right dose, and see how the body processes it. Researchers will also watch for any signs that the drug is shrinking tumors.

What this could mean

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

Active substance
EXS74539 (REC-4539), an oral drug
What this could lead to
If successful, this could lead to a new treatment option for several types of solid tumors.
What could go wrong
This is an early Phase 1 trial with only 40 participants, focused on safety and dosing. It is too early to know if the drug will be effective or have manageable side effects.

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

Apr 2026

Expected to finish

Mar 2029

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.

Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Histologically confirmed diagnosis of the following solid tumors: * SCLC * High grade neuroendocrine or small cell carcinomas of non-lung origin * Non-small cell lung cancer \[NSCLC\] * Prostate cancer * Ovarian cancer * Renal carcinoma \[clear and non-clear cell\] * Head and neck squamous cell carcinoma * Hepatic cancer * Gastric cancer * Triple-negative breast cancer \[TNBC\] * Participant disease should have progressed, relapsed or the participants should have been intolerant to at least one prior standard systemic therapy for their respective underlying malignancy. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Key Exclusion Criteria: * Any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's safety or ability to participate in the study. * Symptomatic brain metastases, leptomeningeal metastases, or spinal cord compression due to disease. Participants with brain metastases must be clinically stable and off corticosteroids and anticonvulsants for ≥1 month prior to study treatment and not require any specific intervention for brain metastases. * Active and clinically significant infection requiring systemic antibacterial, antiviral, or antifungal therapy \<7 days of the first scheduled dose of the study treatment. * Significant cardiac abnormalities. * Major surgery within 28 days prior to the start of study treatment. Note: Other protocol-defined inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

carcinoma of liver and intrahepatic biliary tract gastric cancer gastric neoplasm head and neck squamous cell carcinoma liver cancer Liver Neoplasms Margins of Excision neuroendocrine carcinoma non-small cell lung carcinoma ovarian cancer prostate cancer renal carcinoma renal cell carcinoma small cell carcinoma small cell lung carcinoma Squamous Cell Carcinoma of Head and Neck triple-negative breast carcinoma

As listed by the trial registrant

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

Gastric cancer Head and neck squamous cell carcinoma HNSCC Hepatic cancer High grade neuroendocrine cancer Non-small cell lung cancer (NSCLC) Ovarian cancer Prostate cancer Renal carcinoma (clear and non-clear cell) Small cell carcinomas of non-lung origin Small cell lung cancer ( SCLC ) Solid tumor Triple negative breast cancer (TNBC)

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

  • START Dallas

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • START Mountain Region

    RECRUITING

    West Valley City, Utah, 84119, United States

  • Start Lacn

    RECRUITING

    Los Angeles, California, 90025, United States

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