Study of EXS74539 for Select Solid Tumors

This study is testing a new oral medication called EXS74539 (REC-4539) in people with certain types of solid tumors, including small cell lung cancer (SCLC), high-grade neuroendocrine cancer, and non-small cell lung cancer (NSCLC). The main goal is to find out how safe the drug is, how well people tolerate it, and what the highest safe dose is. Researchers will be looking for side effects and dose-limiting toxicities (side effects that are severe enough to stop or reduce treatment). You may be able to join if you are 18 or older, have a good performance status (meaning you can perform daily activities), and have one of the specified solid tumors. The current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive the study drug EXS74539. It aims to enroll 40 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-emergent adverse events and dose interruptions/modifications for up to 3 years. Dose-limiting toxicity will be assessed for up to 28 days.

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NCT07517198

Dose Determining Study of EXS74539 (REC-4539) in Participants With Select Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
~40 participants
Updated 2026-06-10 on ClinicalTrials.gov
What's tested:EXS74539

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured over Up to 3 years
+2 more outcomes measured
Solid Tumor
Small Cell Lung Cancer (SCLC)
High Grade Neuroendocrine Cancer
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 (HNSCC)
Hepatic Cancer
Gastric Cancer
Triple-negative Breast Cancer (TNBC)
3 sites across 3 states
California1
Texas1
Utah1

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Eligibility criteria

Inclusion

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.

Exclusion

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.
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Up to 3 years
  • Number of Participants with Dose-limiting Toxicity (DLT)Up to 28 days
  • Number of Participants with Dose Interruptions and Dose ModificationsUp to 3 years