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

Study Identifier:
EXS74539-002
CT.gov Identifier:
NCT07517198
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study 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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Breast Cancers
Non-Small Cell Lung Cancer
Ovarian
Prostate
Small Cell Lung
Renal
Gastric
Liver
Head & Neck
Neuroendocrine
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: EXS74539
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Drug: EXS74539
Drug: Drug: EXS74539
Drug: Oral administration
Drug: Other Names: REC-4539
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
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.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Mountain Region
West Valley City, UT, United States, 84119
Investigator
William McKean
Status
Recruiting
Condition(s) Treated at Site
Breast Cancers
Non-Small Cell Lung Cancer
Ovarian
Prostate
Small Cell Lung
Renal
Gastric
Liver
Head & Neck
Neuroendocrine
Location
START Los Angeles
Los Angeles, CA, United States, 90025
Investigator
Lasika Seneviratne
Status
Recruiting
Condition(s) Treated at Site
Breast Cancers
Non-Small Cell Lung Cancer
Ovarian
Prostate
Small Cell Lung
Renal
Gastric
Liver
Head & Neck
Neuroendocrine
Location
START Dallas Fort Worth
Fort Worth, TX, United States, 76104
Investigator
Henry Xiong
Status
Recruiting
Condition(s) Treated at Site
Breast Cancers
Non-Small Cell Lung Cancer
Ovarian
Prostate
Small Cell Lung
Renal
Gastric
Liver
Head & Neck
Neuroendocrine
Location
START New Jersey
East Brunswick, NJ, United States, 08816
Investigator
Neel Belani
Status
Recruitment on Hold
Condition(s) Treated at Site
Breast Cancers
Non-Small Cell Lung Cancer
Ovarian
Prostate
Small Cell Lung
Renal
Gastric
Liver
Head & Neck
Neuroendocrine