Assessing GTAEXS617 for advanced 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 phase 1/2 study evaluates the safety, tolerability, pharmacokinetics, and anti-tumor activity of GTAEXS617-001 in patients with advanced solid tumors. The study includes patients with specific types of cancers such as head and neck squamous cell carcinoma, colorectal adenocarcinoma, pancreatic adenocarcinoma, non-small cell lung cancer, breast cancer, and ovarian epithelial carcinoma. Participants will receive GTAEXS617 either as a standalone treatment or in combination with other therapies. The study aims to determine the effectiveness of this treatment in patients whose cancers have progressed after standard treatments.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Life expectancy \> 3 months.
* One of the following histologically or cytologically confirmed advanced solid tumors: head and neck squamous cell carcinoma (HNSCC), pancreatic adenocarcinoma, non-small cell lung cancer (NSCLC), breast carcinoma (hormone receptor-positive \[HR+\] and Human Epidermal Growth Receptor 2 negative \[HER2-\] that has progressed to a prior treatment with Cyclin-Dependent Kinase 4 (CDK4)/ Cyclin-Dependent Kinase 6 \[CDK6\] inhibitor), or platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (HGSOC), or triple negative breast cancer (TNBC).
* Must have disease that is advanced (ie, surgery or radiotherapy are not considered to be potentially curative), recurrent, or metastatic following SoC treatments.
* Adequate hematological, liver, and renal function.
* Must have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases.

Key Exclusion Criteria:

* Active and clinically significant (CS) infection.
* Refractory nausea and/or vomiting, chronic gastrointestinal disease, or previous significant bowel resection, with CS sequelae that would preclude adequate absorption of GTAEXS617.
* Symptomatic central nervous system (CNS) malignancy or metastases.
* Concurrent active or previous malignancy.
* Prior organ or allogeneic stem-cell transplantation.
* Moderate or severe cardiovascular disease.
* Received anticancer therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment.
* Received treatment with known strong/moderate inhibitors and/or strong inducers of cytochrome P450 3A isoform subfamily (CYP3A) within 14 days or 5 half-lives before the first dose of study treatment.
* Received treatment with known inhibitors or inducers of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) within 14 days or 5 half-lives before the first dose of study treatment.
* Received treatment with known substrates of organic anion transporting peptide or BCRP within 14 days or 5 half-lives before the first dose of study treatment.
* Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy
* Has had or is scheduled to have major surgery \<28 days prior to the first dose of study treatment.

Note: Other protocol Inclusion/Exclusion criteria may apply.

Where it's running

• USC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• START Midwest
  Grand Rapids, Michigan, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• The Ohio State University
  Columbus, Ohio, United States Recruiting
• START San Antonio
  San Antonio, Texas, United States Recruiting
• START Mountain Region
  West Valley City, Utah, United States Recruiting

Study contacts

• Study coordinator: Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
• Email: clinicaltrials@recursionpharma.com
• Phone: 385-374-1724

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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.