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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests EXS74539 (REC-4539) in people with certain solid tumors. It will check safety, side effects, and the highest dose people can tolerate.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You can do most daily activities, though you may need to avoid hard physical activity.
  • A tissue test must confirm one of the cancers listed below.
  • Small cell lung cancer or non-small cell lung cancer.
  • High-grade neuroendocrine cancer (fast-growing cancer of cells with nerve and hormone functions) or small cell cancer outside the lungs.
  • Prostate, ovarian, kidney (clear cell or non-clear cell), liver, or stomach cancer.
  • Head and neck squamous cell cancer (cancer of flat lining cells), or triple-negative breast cancer (which lacks three common treatment targets).
  • Your cancer grew or came back after at least one standard drug treatment, or you could not tolerate that treatment.
  • Your cancer can be measured using the study’s standard rules.

Who can't join

  • A medical or mental health condition that the study doctor thinks could make joining unsafe or keep you from taking part.
  • Cancer spread to the brain that causes symptoms, spread to the lining around the brain or spinal cord, or cancer pressing on the spinal cord.
  • If cancer has spread to your brain: it is not stable, needs treatment, or you have taken steroids or seizure medicines within one month before study treatment.
  • An active, significant infection needing medicines that work throughout the body within 7 days before the first study dose.
  • Serious heart problems.
  • Major surgery within 28 days before study treatment starts.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (3)

CA

TX

UT