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
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 range18 Years
SexALL
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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…
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.