RecruitingPhase 1 / Phase 2NCT05985655
Official study title

Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

Study summary

The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617 (REC-617) in participants with advanced solid tumors.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedGTAEXS617 and SoC

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · HER2

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 13, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?15 U.S. locations

Locations may change over time.

Who runs it?Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Interventions being studied
Drug: GTAEXS617; Drug: SoC
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Key
  • 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
Reasons someone may not be able to joinExclusion 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/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • USC Norris Comprehensive Cancer CenterLos Angeles, California
  • START MidwestGrand Rapids, Michigan
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • The Ohio State UniversityColumbus, Ohio
  • START San AntonioSan Antonio, Texas
  • START Mountain RegionWest Valley City, Utah
  • GZA Ziekenhuizen - Campus Sint-AugustinusAntwerp
  • Clinique Universitaires Saint-LucBrussels
  • Institute Jules BordetBrussels
  • CHU Sart TilmanLiège
  • The Beatson West of Scotland Cancer CentreGlasgow
  • UCL Hospitals NHS Foundation TrustLondon

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 13, 2026. Always confirm current availability with the study team.

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