Actively Recruiting
A Phase 1, Open-Label Study to Assess Safety and Dose of EXS74539 in Adults With Select Solid Tumors
Led by Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. · Updated on 2026-04-08
40
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and maximum tolerated dose of EXS74539 (REC-4539) in adults with select solid tumors. This phase 1, multicenter, open-label study focuses on participants whose cancer has progressed, relapsed, or who could not tolerate at least one prior standard systemic therapy. The trial includes various tumor types such as lung, prostate, ovarian, renal, head and neck, hepatic, gastric, and triple-negative breast cancers. Participants receive EXS74539 as an oral treatment during the study. The trial uses a dose-escalation design to find the maximum tolerated dose. The treatment period can last up to approximately three years, with close monitoring for dose-limiting toxicities and any necessary dose interruptions or modifications. Throughout the study, participants undergo regular assessments for treatment-emergent and serious adverse events, as well as pharmacokinetic measurements like maximum concentration and drug exposure over time. Researchers will also evaluate tumor response rates, duration of response, progression-free survival, and overall survival. Safety and efficacy are monitored continuously, with follow-up lasting up to three years after starting treatment.
CONDITIONS
Brief Title
Dose Determining Study of EXS74539 (REC-4539) in Participants With Select Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Histologically confirmed diagnosis of specific solid tumors including small cell lung cancer, high grade neuroendocrine or small cell carcinomas of non-lung origin, non-small cell lung cancer, prostate cancer, ovarian cancer, renal carcinoma (clear and non-clear cell), head and neck squamous cell carcinoma, hepatic cancer, gastric cancer, or triple-negative breast cancer
- Disease has progressed, relapsed, or participant is intolerant to at least one prior standard systemic therapy
- Measurable disease according to RECIST version 1.1 criteria
You will not qualify if you...
- Any medical or psychiatric condition that could jeopardize safety or ability to participate
- Symptomatic brain metastases, leptomeningeal metastases, or spinal cord compression; brain metastases must be stable and off corticosteroids and anticonvulsants for at least 1 month
- Active significant infection requiring systemic antibacterial, antiviral, or antifungal therapy within 7 days before starting study treatment
- Significant cardiac abnormalities
- Major surgery within 28 days prior to starting study treatment
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 3 years
Participants receive oral EXS74539 as the investigational drug for their solid tumors.
Trial Site Locations
Total: 2 locations
1
START Dallas
Fort Worth, Texas, United States, 76104
Actively Recruiting
2
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
Research Team
E
Exscientia AI Ltd.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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