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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
EXS74539 		EXS74539
  • Drug: EXS74539
    Oral administration
    Other names:
    • REC-4539

Recruiting Locations

START Dallas
Fort Worth, Texas 76104

START Mountain Region
West Valley City, Utah 84119

More Details

Status
Recruiting
Sponsor
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.

Study Contact

Exscientia AI Ltd.
385-374-1724
clinicaltrials@recursion.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.