NCT07517198 Dose Determining Study of EXS74539 (REC-4539) in Participants With Select Solid Tumors
| NCT ID | NCT07517198 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-04-13 |
| Primary Completion | 2029-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2026-04-13 with a primary completion date of 2029-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07517198 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07517198 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07517198 currently recruiting?
Yes, NCT07517198 is actively recruiting participants. Contact the research team at clinicaltrials@recursion.com for enrollment information.
Where is the NCT07517198 trial being conducted?
This trial is being conducted at Los Angeles, United States, Fort Worth, United States, West Valley City, United States.
Who is sponsoring the NCT07517198 clinical trial?
NCT07517198 is sponsored by Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.. The trial plans to enroll 40 participants.