Recruiting
Phase 1

EXS74539

Sponsor:

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

Code:

NCT07517198

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)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EXS74539

Study Details

Brief summary:

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)

Study ID

NCT07517198

Start date

Apr 13, 2026

Status verified date

Jun, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: EXS74539

EXS74539

Interventions

EXS74539

Oral administration

Primary outcome measure

  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 3 years ]
  • Number of Participants with Dose-limiting Toxicity (DLT) [ Time Frame: Up to 28 days ]
  • Number of Participants with Dose Interruptions and Dose Modifications [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Exscientia AI Ltd.

385-374-1724clinicaltrials@recursion.com

Locations

Start Lacn

Recruiting

Los Angeles, California, United States, 90025

START Dallas

Recruiting

Fort Worth, Texas, United States, 76104

START Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

More Information

Sponsor

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

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Keywords

  • Solid Tumors
  • 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)
  • LSD1 inhibitor
  • EXS74539
  • REC-4539

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. on 2026-06-10.