Dose Determining Study of EXS74539 (REC-4539) in Participants With Select Solid Tumors

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

  • 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)

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