Recruiting
Dose Determining Study of EXS74539 (REC-4539) in Participants With Select Solid Tumors
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.
ClinicalTrials.gov IDNCT07517198
PhasePHASE1
Enrollment40
SponsorExscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Age18 Years
SexALL
Conditions studied
Solid Tumor, Small Cell Lung Cancer (SCLC), High Grade Neuroendocrine Cancer, 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 (HNSCC), Hepatic Cancer, Gastric Cancer, Triple-negative Breast Cancer (TNBC)
About this study
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.
Interventions
- Drug: EXS74539 — Oral administration
Primary outcomes
- 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)
Eligibility information
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.
Study locations
- Start Lacn, Los Angeles, California 90025 United States
- START Dallas, Fort Worth, Texas 76104 United States
- START Mountain Region, West Valley City, Utah 84119 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.