Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
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
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)

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

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