NCT07517198RecruitingPhase 1
Dose Determining Study of EXS74539 (REC-4539) in Participants With 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
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 27 Mar 2026
- Start date
- 13 Apr 2026
- Primary completion date
- Mar 2029
- Lead sponsor
- Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
- Diseases
- Prostate cancer, Triple-negative breast cancer, Head and neck cancer, Neuroendocrine tumours, Kidney cancer, Lung cancer, Liver and biliary tract cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT07517198
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 40
- From 13 Apr 2026 to the primary completion date, Mar 2029
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Major surgery within 28 days prior to the start of study treatment.
- Note: Other protocol-defined inclusion and exclusion criteria may apply.
Other illness
- 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.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| START Dallas Coordinator of this site? Confirm its status | Fort Worth | United States | Recruiting |
| Start Lacn Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| START Mountain Region Coordinator of this site? Confirm its status | West Valley City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.