New hope for Hard-to-Treat cancers: GTAEXS617 enters human trials
NCT ID NCT05985655
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times
Summary
This study tests a new drug called GTAEXS617 in people with advanced solid tumors (like lung, pancreatic, or ovarian cancer) that have not responded to standard treatments. The main goals are to check safety, find the right dose, and see if the drug can shrink tumors. About 230 participants will take part in this early-phase trial.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 230 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2023
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
15 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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CHU Sart Tilman
RECRUITINGLiège, Belgium
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Clinique Universitaires Saint-Luc
RECRUITINGBrussels, Belgium
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GZA Ziekenhuizen - Campus Sint-Augustinus
RECRUITINGAntwerp, Belgium
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Institute Jules Bordet
RECRUITINGBrussels, Belgium
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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Newcastle Upon Tyne NHS Foundation Trust
RECRUITINGNewcastle upon Tyne, United Kingdom
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Oxford University Hospitals NHS Foundation Trust
RECRUITINGOxford, United Kingdom
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START Midwest
RECRUITINGGrand Rapids, Michigan, 49546, United States
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START Mountain Region
RECRUITINGWest Valley City, Utah, 84119, United States
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START San Antonio
RECRUITINGSan Antonio, Texas, 78229, United States
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The Beatson West of Scotland Cancer Centre
RECRUITINGGlasgow, United Kingdom
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The Christie NHS Foundation Trust
RECRUITINGManchester, United Kingdom
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The Ohio State University
RECRUITINGColumbus, Ohio, 43210, United States
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UCL Hospitals NHS Foundation Trust
RECRUITINGLondon, United Kingdom
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USC Norris Comprehensive Cancer Center
RECRUITINGLos Angeles, California, 90089, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New chemo cocktail targets pancreatic cancer at every stage
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Green dye vs blue dye: which finds Cancer-Linked lymph nodes better?
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- The gatekeepers of tumors: scientists probe how blood vessels let immune cells in