Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors
NCT ID: NCT05985655
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
165 participants
INTERVENTIONAL
2023-07-06
2028-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1: Dose Escalation Monotherapy
Participants will receive GTAEXS617 oral tablets in increasing doses.
GTAEXS617
Administered as specified in the treatment arm.
Phase 1: Dose Escalation Combination Therapy
Participants will receive GTAEXS617 oral tablets in increasing doses in combination with standard of care (SoC) treatment.
GTAEXS617
Administered as specified in the treatment arm.
SoC
Participants will receive either fulvestrant (breast cancers) or paclitaxel + bevacizumab (HGSOC) as specified in the treatment arm.
Phase 2: Dose Expansion Monotherapy
Participants will receive GTAEXS617 oral tablets at Recommended Phase 2 Dose (RP2D).
GTAEXS617
Administered as specified in the treatment arm.
Phase 2: Dose Expansion Combination Therapy
Participants will receive GTAEXS617 oral tablets at RP2D in combination with SoC treatment.
GTAEXS617
Administered as specified in the treatment arm.
SoC
Participants will receive either fulvestrant (breast cancers) or paclitaxel + bevacizumab (HGSOC) as specified in the treatment arm.
Interventions
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GTAEXS617
Administered as specified in the treatment arm.
SoC
Participants will receive either fulvestrant (breast cancers) or paclitaxel + bevacizumab (HGSOC) as specified in the treatment arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Cluster of Differentiation 4 \[CD4\] / Cyclin-Dependent Kinase 6 \[CDK6\] inhibitor), or platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (HGSOC).
* 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.
Exclusion Criteria
* 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 1B3 (OATP1B3) 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.
18 Years
ALL
No
Sponsors
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Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Exscientia AI Ltd.
Locations
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START Midwest
Grand Rapids, Michigan, United States
START San Antonio
San Antonio, Texas, United States
START Mountain Region
West Valley City, Utah, United States
GZA Ziekenhuizen - Campus Sint-Augustinus
Antwerp, , Belgium
Clinique Universitaires Saint-Luc
Brussels, , Belgium
Institute Jules Bordet
Brussels, , Belgium
CHU Sart Tilman
Liège, , Belgium
The Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
UCL Hospitals NHS Foundation Trust
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Newcastle Upon Tyne NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
Countries
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Central Contacts
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Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Role: CONTACT
Other Identifiers
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GTAEXS617-001
Identifier Type: -
Identifier Source: org_study_id
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