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NCT Number: NCT07517198

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.

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Key information

Conditions

Solid Tumor Adenocarcinoma Adnexal Diseases Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma (HNSCC) Hepatic Cancer High Grade Neuroendocrine Cancer Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Margins of Excision Morphological and Microscopic Findings Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-small Cell Lung Cancer (NSCLC) Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pathological Conditions, Signs and Symptoms Prostate Cancer Prostatic Diseases Prostatic Neoplasms Renal Carcinoma (Clear and Non-clear Cell) Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Small Cell Carcinomas of Non-lung Origin Small Cell Lung Cancer (SCLC) Small Cell Lung Carcinoma Squamous Cell Carcinoma of Head and Neck Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Triple Negative Breast Neoplasms Triple-Negative Breast Cancer (TNBC) Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Start Lacn, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EXS74539

Drug

Oral administration

Other names: REC-4539

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 3 years

  2. Number of Participants with Dose-limiting Toxicity (DLT)

    Time frame: Up to 28 days

  3. Number of Participants with Dose Interruptions and Dose Modifications

    Time frame: Up to 3 years

Secondary outcomes

  1. Maximum Concentration (Cmax) of EXS74539

    Time frame: Cycle 1 Day 25 and at end of treatment (up to approximately 3 years)

  2. Time to Cmax (tmax) of EXS74539

    Time frame: Cycle 1 Day 25 and at end of treatment (up to approximately 3 years)

  3. Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-last]) of EXS74539

    Time frame: Cycle 1 Day 1 through end of treatment (up to approximately 3 years)

  4. Objective Response Rate (ORR)

    Time frame: Up to 3 years

  5. Duration of Response (DoR)

    Time frame: Up to 3 years

  6. Progression-free Survival (PFS)

    Time frame: Up to 3 years

  7. Overall Survival (OS)

    Time frame: Up to 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Exscientia AI Ltd.

CONTACT

[email protected]

385-374-1724

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

A Phase 1, Multicenter, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability, and Efficacy of EXS74539 as Monotherapy in Participants With Select Solid Tumors

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 8, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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