Dose Determining Study of EXS74539 (REC-4539) in Participants With Select Solid Tumors (NCT07517198) | Clinical Trial Compass
RecruitingPhase 1
Dose Determining Study of EXS74539 (REC-4539) in Participants With Select Solid Tumors
United States40 participantsStarted 2026-04-13
Plain-language summary
The primary purpose of this study is to determine the safety, tolerability, and maximum tolerated dose (MTD) of EXS74539 (REC-4539) in participants with select solid tumors.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timeframe: Up to 3 years
2
Number of Participants with Dose-limiting Toxicity (DLT)
Timeframe: Up to 28 days
3
Number of Participants with Dose Interruptions and Dose Modifications
Timeframe: Up to 3 years
Trial details
NCT IDNCT07517198
SponsorExscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.