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

ConditionsSolid 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)

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorExscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

SCLC

High grade neuroendocrine or small cell carcinomas of non-lung origin

Non-small cell lung cancer [NSCLC]

Disqualifiers

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.

Trial design

Treatments tested in this trial

EXS74539

Treatment groups

40 Participants

are divided into 1 treatment group

Sponsors and collaborators

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

Lead sponsor

Source ClinicalTrials.gov