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Looking for participantsPhase1/Phase2

Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

Sponsor: Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.

NCT ID: NCT05985655

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
GTAEXS617 (drug), SoC (drug)
How long the study runs
Study runs about 58 months (dates as stated)
About the drug or intervention
GTAEXS617 — drug: Administered as specified in the treatment arm. · SoC — drug: Participants will receive selected SoC regimen (fulvestrant, paclitaxel + bevacizumab, pegylated liposomal doxorubicin, or capecitabine) administered as specified in the treatment arm.
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a new drug called GTAEXS617 in people with certain advanced solid tumours, including head and neck cancer, pancreatic cancer, non-small cell lung cancer, some ovarian and breast cancers. Not stated — ask the trial team what the drug is designed to do. The study is run by Exscientia AI Ltd., part of Recursion Pharmaceuticals.

Who can take part

  • Have one of these advanced tumours: head and neck squamous cell carcinoma, pancreatic adenocarcinoma, non-small cell lung cancer, hormone receptor-positive and HER2-negative breast cancer that got worse after a CDK4/CDK6 inhibitor, platinum-resistant high-grade ovarian, primary peritoneal or fallopian tube cancer, or triple negative breast cancer
  • Disease is advanced, has come back, or has spread, and surgery or radiotherapy would not be able to cure it
  • Fairly fit and well (performance status 0-1), with a life expectancy of more than 3 months
  • Healthy enough blood, liver and kidney function
  • Have a tumour or spread of cancer that can be biopsied (not in the bone)

Who may not be able to

  • An active infection that is clinically significant
  • Ongoing nausea, vomiting or bowel problems, or major bowel surgery before, that could stop the body absorbing the study drug
  • Cancer spread to the brain or spinal cord that is causing symptoms
  • Another cancer now or in the past
  • A previous organ or stem-cell transplant
  • Moderate or severe heart disease
  • Cancer treatment within 28 days or 5 half-lives (whichever is shorter) before the first study dose
  • Certain medicines that affect liver enzymes (CYP3A) or transport proteins (P-gp or BCRP) within 14 days or 5 half-lives before the first dose
  • Side effects from earlier chemotherapy or radiotherapy that have not settled or are not stable
  • Major surgery in the 28 days before the first dose, or major surgery planned

What taking part involves

  • • Taking the study drug GTAEXS617 — Not stated — ask the trial team how it is given, how often, and at what doses
  • • Having a biopsy of a tumour or metastasis

Time commitment: Not stated — ask the trial team how long the study lasts, how many visits are needed, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
230
Started
2023-07-06
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for head and neck squamous cell carcinoma (hnscc)
  • • Phase1/Phase2 - 230 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with head and neck squamous cell carcinoma (hnscc)

Where?

  • • Glasgow - The Beatson West of Scotland Cancer Centre
  • • London - UCL Hospitals NHS Foundation Trust
  • • Manchester - The Christie NHS Foundation Trust
  • • Newcastle upon Tyne - Newcastle Upon Tyne NHS Foundation Trust
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Head and Neck Squamous Cell Carcinoma (HNSCC)Pancreatic AdenocarcinomaNon-small Cell Lung Cancer (NSCLC)Platinum-resistant High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers (HGSOC)Hormone Receptor Positive [HR+] and Human Epidermal Growth Factor Receptor 2 Negative [HER2-] Breast CarcinomaTriple Negative Breast Cancer (TNBC)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

HER2Receptor 2 negativetriple negative

Treatment history

Treatments you must have had:

  • ✓ Cyclin-Dependent Kinase 4 (CDK4)/ Cyclin-Dependent Kinase 6 \[CDK6\] inhibit
  • ✓ tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases

What the study is looking for

  • ✓activity scale (ECOG) performance status 0-1.
  • ✓Life expectancy \> 3 months.
  • ✓Must have disease that is advanced (ie, surgery or radiotherapy are not considered to be potentially curative),...
  • ✓Adequate blood, liver, and kidney function.
  • ✓Must have tumor lesion(s) or metastases amenable to biopsy, excluding bone metastases.

Who cannot take part

  • ✗Active and clinically significant (CS) infection.
  • ✗Refractory nausea and/or vomiting, chronic gastrointestinal disease, or previous significant bowel resection, with...
  • ✗causing symptoms central nervous system (CNS) cancer or metastases.
  • ✗Concurrent active or previous cancer.
  • ✗Prior organ or allogeneic stem-cell transplantation.
See the full 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 Is This Study? (5 UK sites)

The Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Recruiting
Site contact (verified)
Jeff EvansPrincipal Investigator

UCL Hospitals NHS Foundation Trust

London, United Kingdom

Recruiting
Site contact (verified)
Martin ForsterPrincipal Investigator

The Christie NHS Foundation Trust

Manchester, United Kingdom

Recruiting
Site contact (verified)
Donna GrahamPrincipal Investigator

Newcastle Upon Tyne NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

Recruiting
Site contact (verified)
Elizabeth Ruth PlummerPrincipal Investigator

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Recruiting
Site contact (verified)
Simon LordPrincipal Investigator

How to Get in Touch

Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.

Sponsor contact

CONTACT

385-374-1724 clinicaltrials@recursionpharma.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08