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Study of GTAEXS617 for Advanced Solid Tumors

This study is testing a drug called GTAEXS617 in people with advanced solid tumors, including certain types of head and neck, pancreatic, lung, ovarian, and breast cancers. Researchers want to see how safe GTAEXS617 is, how well your body handles it, and if it can shrink tumors. Some participants will receive GTAEXS617, while others will receive standard treatments like fulvestrant or paclitaxel. The study is looking for side effects and how many participants' tumors shrink. You may be able to join if you are 18 or older, have a good performance status (ECOG 0-1), and a life expectancy of more than 3 months. The study aims to enroll 230 participants.

Study design
This is an interventional study with a planned enrollment of 230 participants. It is testing GTAEXS617 against standard-of-care treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 2 years to monitor for side effects and tumor response.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05985655

Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
~230 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:GTAEXS617SoC

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured over Up to 2 years
+2 more outcomes measured

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)
Pancreatic Adenocarcinoma
Non-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 Carcinoma
Triple Negative Breast Cancer (TNBC)

Explore related trials

Breast CarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaMalignant Ovarian NeoplasmPancreatic AdenocarcinomaSolid Neoplasm

Where it's being run

15 sites across 8 states
United Kingdom5
Belgium4
California1
Michigan1
New York1
Ohio1
Texas1
Utah1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Exscientia AI Ltd.

Who to contact

Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
[email protected]
385-374-1724
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Number of Participants With Treatment Emergent Adverse Events (TEAEs)Up to 2 years
  • Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)Up to 28 days
  • Phase 2 : Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1Up to 2 years