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)
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 Modifications — Up to 3 years
Trial sites (3)
Facility
City
Region
Status
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
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.
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