Dose Determining Study of EXS74539 (REC-4539) in Participants With Select Solid Tumors
Recruiting · NCT07517198 · Interventional (participants receive a specific treatment) · Lead sponsor: Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
EXS74539
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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 it is running
6 locations listed across 3 US states.
- Start Lacn - Los Angeles, California, United States
- Start Lacn - Los Angeles, California, United States
- START Dallas - Fort Worth, Texas, United States
- START Dallas - Fort Worth, Texas, United States
- START Mountain Region - West Valley City, Utah, United States
- START Mountain Region - West Valley City, Utah, United States