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
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
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
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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