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Assessing GTAEXS617 for advanced solid tumors

A Phase 1/2 Open-label Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of GTAEXS617 in Patients With Advanced Solid Tumors

Phase1; Phase2 Interventional Exscientia AI Limited · NCT05985655

This study is testing a new treatment called GTAEXS617 to see if it can help people with advanced solid tumors, like certain types of cancer, when other treatments haven't worked.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment230 (estimated)
Ages18 Years and up
SexAll
SponsorExscientia AI Limited Industry-sponsored
Drugs / interventionschemotherapy
Locations13 sites (Los Angeles, California and 12 other locations)
Trial IDNCT05985655 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced solid tumors who have a life expectancy of more than three months and meet specific health criteria.

Not a fit: Patients with active infections, significant gastrointestinal issues, or those who have had prior significant bowel resections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that have limited treatment options.

How similar studies have performed: Other studies have shown promise with similar approaches, but the specific treatment GTAEXS617 is being evaluated for its unique properties.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Los Angeles, California and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Head and Neck Squamous Cell CarcinomaPancreatic AdenocarcinomaNon-small Cell Lung CancerPlatinum-resistant High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube CancersHormone Receptor Positive [HR+] and Human Epidermal Growth Factor Receptor 2 Negative [HER2-] Breast CarcinomaTriple Negative Breast CancerAdvanced Solid Tumor
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.