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Clinical Trials in the USA / NCT07517198
Recruiting Phase 1

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

NCT07517198 · tracked via the Priya Life Science USA tracker
Sponsor
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Phase
Phase 1
Started
2026-04-13
Last updated
2026-06-10

Condition(s) studied

Solid TumorSmall Cell Lung Cancer (SCLC)High Grade Neuroendocrine CancerSmall Cell Carcinomas of Non-lung OriginNon-small Cell Lung Cancer (NSCLC)Prostate CancerOvarian CancerRenal Carcinoma (Clear and Non-clear Cell)Head and Neck Squamous Cell Carcinoma (HNSCC)Hepatic CancerGastric CancerTriple-negative Breast Cancer (TNBC)

Investigational drug(s) / intervention(s)

EXS74539

EXS74539: Oral administration

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (3)

FacilityCityRegionStatus
Start Lacn Los Angeles California Recruiting
START Dallas Fort Worth Texas Recruiting
START Mountain Region West Valley City Utah Recruiting

More Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07517198 on ClinicalTrials.gov ↗ ← All trials in the USA