NCT07517198

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
33mo left

Started Apr 2026

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Mar 2029

First Submitted

Initial submission to the registry

March 27, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 13, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

2.9 years

First QC Date

March 27, 2026

Last Update Submit

June 9, 2026

Conditions

Solid TumorSmall Cell Lung Cancer (SCLC)High Grade Neuroendocrine CancerProstate CancerOvarian CancerHepatic CancerGastric CancerTriple-negative Breast Cancer (TNBC)Renal Carcinoma (Clear and Non-clear Cell)Small Cell Carcinomas of Non-lung OriginNon-small Cell Lung Cancer (NSCLC)Head and Neck Squamous Cell Carcinoma (HNSCC)

Keywords

Solid TumorsSmall Cell Lung Cancer (SCLC)High grade neuroendocrine cancerSmall cell carcinomas of non-lung originNon-small cell lung cancer (NSCLC)Prostate cancerOvarian cancerRenal carcinoma (clear and non-clear cell)Head and neck squamous cell carcinoma (HNSCC)Hepatic cancerGastric cancerTriple-negative breast cancer (TNBC)LSD1 inhibitorEXS74539REC-4539

Outcome Measures

Primary Outcomes (3)

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

    Up to 3 years

  • Number of Participants with Dose-limiting Toxicity (DLT)

    Up to 28 days

  • Number of Participants with Dose Interruptions and Dose Modifications

    Up to 3 years

Secondary Outcomes (7)

  • Maximum Concentration (Cmax) of EXS74539

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

  • Time to Cmax (tmax) of EXS74539

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

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

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

  • Objective Response Rate (ORR)

    Up to 3 years

  • Duration of Response (DoR)

    Up to 3 years

  • +2 more secondary outcomes

Study Arms (1)

EXS74539

EXPERIMENTAL

EXS74539

Drug: EXS74539

Interventions

EXS74539DRUG

Oral administration

Also known as: REC-4539
EXS74539

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Start Lacn

Los Angeles, California, 90025, United States

RECRUITING

START Dallas

Fort Worth, Texas, 76104, United States

RECRUITING

START Mountain Region

West Valley City, Utah, 84119, United States

RECRUITING

MeSH Terms

Conditions

Small Cell Lung CarcinomaCarcinoma, Non-Small-Cell LungProstatic NeoplasmsOvarian NeoplasmsCarcinoma, Renal CellMargins of ExcisionSquamous Cell Carcinoma of Head and NeckLiver NeoplasmsStomach NeoplasmsTriple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Neoplasms, FemaleEndocrine System DiseasesGonadal DisordersAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeKidney NeoplasmsUrologic NeoplasmsKidney DiseasesUrologic DiseasesMorphological and Microscopic FindingsPathological Conditions, Signs and SymptomsCarcinoma, Squamous CellHead and Neck NeoplasmsDigestive System NeoplasmsDigestive System DiseasesLiver DiseasesGastrointestinal NeoplasmsGastrointestinal DiseasesStomach DiseasesBreast NeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Exscientia AI Ltd.

CONTACT

385-374-1724clinicaltrials@recursion.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2026

First Posted

April 8, 2026

Study Start

April 13, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

June 10, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(3)