Dose-finding of EXS74539 (REC-4539) in select solid tumors
A Phase 1, Multicenter, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability, and Efficacy of EXS74539 as Monotherapy in Participants With Select Solid Tumors
This study will try different doses of the experimental drug EXS74539 in adults with select solid tumors to find a safe and tolerable dose.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Exscientia AI Limited Industry-sponsored |
| Locations | 2 sites (Fort Worth, Texas and 1 other locations) |
| Trial ID | NCT07517198 on ClinicalTrials.gov |
What this trial studies
This is a phase 1, open-label dose-escalation trial of EXS74539 (REC-4539) in adults with select solid tumors, including small cell and non-small cell lung cancers and high-grade neuroendocrine carcinomas. Eligible participants must have measurable disease by RECIST v1.1, an ECOG performance status of 0–1, and disease that has progressed after or was intolerant to at least one prior systemic therapy. The study enrolls patients into ascending dose cohorts to identify the maximum tolerated dose and recommended phase 2 dose while monitoring for dose-limiting toxicities, adverse events, and pharmacokinetics. Safety, tolerability, and any preliminary signs of anti-tumor activity will be recorded to inform further development.
Who should consider this trial
Good fit: Adults with measurable, progressive select solid tumors (including SCLC, NSCLC, high-grade neuroendocrine carcinomas, and certain other listed tumor types) who have ECOG 0–1 and have failed or been intolerant to at least one standard systemic therapy.
Not a fit: Patients without measurable disease, with ECOG performance status >1, or who have not yet tried standard therapies are unlikely to benefit from this early-phase dose-finding trial.
Why it matters
Potential benefit: If successful, EXS74539 could offer a new treatment option for patients with advanced or treatment-resistant solid tumors.
How similar studies have performed: Dose-escalation studies of novel oncology agents have sometimes led to later successful development, but EXS74539 appears to be a novel agent with limited published human data so far.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Fort Worth, Texas and 1 other locations
- START Dallas — Fort Worth, Texas, United States (Recruiting)
- START Mountain Region — West Valley City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Exscientia AI Ltd.
- Email: clinicaltrials@recursion.com
- Phone: 385-374-1724
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.