Dose-finding of EXS74539 (REC-4539) in select solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1, open-label dose-escalation trial of EXS74539 (REC-4539) in adults with select solid tumors, including small cell and non-small cell lung cancers and high-grade neuroendocrine carcinomas. Eligible participants must have measurable disease by RECIST v1.1, an ECOG performance status of 0–1, and disease that has progressed after or was intolerant to at least one prior systemic therapy. The study enrolls patients into ascending dose cohorts to identify the maximum tolerated dose and recommended phase 2 dose while monitoring for dose-limiting toxicities, adverse events, and pharmacokinetics. Safety, tolerability, and any preliminary signs of anti-tumor activity will be recorded to inform further development.

Why it matters

Who can join: the full rules

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.

Where it's running

• Start Lacn
  Los Angeles, California, United States Recruiting
• START Dallas
  Fort Worth, Texas, United States Recruiting
• START Mountain Region
  West Valley City, Utah, United States Recruiting

Study contacts

• Study coordinator: Exscientia AI Ltd.
• Email: clinicaltrials@recursion.com
• Phone: 385-374-1724

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating MT-4561 in Patients with Advanced Solid Tumors

  This study is testing a new drug called MT-4561 to see if it is safe and effective for people with advanced solid tumors.

  Recruiting at 6 sites Phase 1/2 Tanabe Pharma America, Inc. · Los Angeles, California and 5 other locations · NCT06943521

• STRO-004 treatment in adults with recurrent or metastatic solid tumors

  This study will test whether STRO-004, alone and with pembrolizumab, is safe and can shrink tumors in adults with several types of metastatic cancers that often express Tissue Factor.

  Recruiting at 9 sites Phase 1 Sutro Biopharma, Inc. · San Diego, California and 8 other locations · NCT07227168

• TH9619 for advanced solid tumors (Phase 1/2)

  This trial will try different doses of TH9619 in adults with advanced solid tumors (including colorectal, head and neck, non-small cell lung, and gastroesophageal cancers) to find a recommended dose and check safety.

  Recruiting at 4 sites Phase 1/2 OneCarbon · Villejuif and 3 other locations · NCT07151040

• Virtual exercise program to preserve function and prevent disability during chemotherapy

  This trial tests whether supervised resistance sessions by video plus short home aerobic workouts help adults 18–64 maintain strength and stay active while receiving curative-intent chemotherapy.

  Recruiting at 29 sites Alliance for Clinical Trials in Oncology · Dublin, California and 29 other locations · NCT07059884

• IDOV-Immune for advanced solid tumors

  This trial will try a single IV infusion of an engineered oncolytic vaccinia virus called IDOV-Immune in adults with advanced solid tumors that no longer respond to standard treatments.

  Recruiting at 5 sites Phase 1 ViroMissile, Inc. · St Louis, Missouri and 4 other locations · NCT06910657

• ImmunoPET imaging for solid tumors targeting Trop2

  This study is testing a new imaging method to see if it can help diagnose solid tumors like bladder and prostate cancer better than current methods.

  Recruiting Phase 2/3 RenJi Hospital · Shanghai · NCT06851663

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.