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New treatment option for Solid Tumor
Official title Dose Determining Study of EXS74539 (REC-4539) in Participants With Select Solid Tumors
ClinicalTrials.gov ID: NCT07517198
What this study is testing
What is EXS74539?
EXS74539 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for solid tumor.
Also referred to as REC-4539.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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]
You likely can't join if
- Any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's safety or...
- Symptomatic brain metastases, leptomeningeal metastases, or spinal cord compression due to disease. Participants with brain metastases must be...
- Active and clinically significant infection requiring systemic antibacterial, antiviral, or antifungal therapy \<7 days of the first scheduled dose...
- 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.
See the full eligibility 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Fort Worth, Texas, United States
- West Valley City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Fort Worth, Texas, United States; West Valley City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.