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Head and Neck Squamous Cell Carcinoma (HNSCC)Phase 1/2ELUCIDATENCT05985655

Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

A Phase 1/2 study testing GTAEXS617 and SoC in people with Head and Neck Squamous Cell Carcinoma (HNSCC) and Pancreatic Adenocarcinoma, run by Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. at 15 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GTAEXS617 and SoC
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
15 sitesin 3 countries
Study dates
6 Jul 2023to May 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

15 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

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

385-374-1724

clinicaltrials@recursionpharma.com

15 sites in 3 countries

United States6 sites, 6 recruiting

  • The Ohio State University

    Columbus, Ohio, 43210

    Recruiting

  • START Midwest

    Grand Rapids, Michigan, 49546

    Recruiting

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90089

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • START San Antonio

    San Antonio, Texas, 78229

    Recruiting

  • START Mountain Region

    West Valley City, Utah, 84119

    Recruiting

Other trials in United States

United Kingdom5 sites, 5 recruiting

  • The Beatson West of Scotland Cancer Centre

    Glasgow

    Jeff Evans

    Recruiting

  • UCL Hospitals NHS Foundation Trust

    London

    Martin Forster

    Recruiting

  • The Christie NHS Foundation Trust

    Manchester

    Donna Graham

    Recruiting

  • Newcastle Upon Tyne NHS Foundation Trust

    Newcastle upon Tyne

    Elizabeth Ruth Plummer

    Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford

    Simon Lord

    Recruiting

Other trials in United Kingdom

Belgium4 sites, 4 recruiting

  • GZA Ziekenhuizen - Campus Sint-Augustinus

    Antwerp

    Recruiting

  • Clinique Universitaires Saint-Luc

    Brussels

    Rachel Galot

    Recruiting

  • Institute Jules Bordet

    Brussels

    Recruiting

  • CHU Sart Tilman

    Liège

    Laurence Lousberg

    Recruiting

Other trials in Belgium

About this study

Official title: A Phase 1/2 Open-label Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of GTAEXS617 in Patients With Advanced Solid Tumors

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.

Being tested
GTAEXS617, SoC
Keywords
Advanced Solid Tumor
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Carcinoma, Non-Small-Cell Lung, Fallopian Tube Neoplasms, Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GTAEXS617Drug

    Also called REC-617

    Administered as specified in the treatment arm.

  • SoCDrug

    Participants will receive selected SoC regimen (fulvestrant, paclitaxel + bevacizumab, pegylated liposomal doxorubicin, or capecitabine) administered as specified in the treatment arm.

Study groups in NCT05985655
Study groupRoleWhat they receive
Phase 1: Dose Escalation MonotherapyExperimentalParticipants will receive GTAEXS617 oral tablets in increasing doses.
Receives: Drug: GTAEXS617
Phase 1: Dose Escalation Combination TherapyExperimentalParticipants will receive GTAEXS617 oral tablets in increasing doses in combination with standard of care (SoC) treatment.
Receives: Drug: GTAEXS617; Drug: SoC
Phase 2: Dose Expansion MonotherapyExperimentalParticipants will receive GTAEXS617 oral tablets at Recommended Phase 2 Dose (RP2D).
Receives: Drug: GTAEXS617
Phase 2: Dose Expansion Combination TherapyExperimentalParticipants will receive GTAEXS617 oral tablets at RP2D in combination with SoC treatment.
Receives: Drug: GTAEXS617; Drug: SoC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    Measured: Up to 2 years

  2. Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)

    Measured: Up to 28 days

  3. Phase 2 : Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: Up to 2 years

Secondary outcomes (7)

  1. Phase 1: ORR as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: Up to 2 years

  2. Maximum Plasma Concentration (Cmax) of GTAEXS617

    Measured: Predose up to 24 hours postdose

  3. Time Maximum Plasma Concentration (Tmax) of GTAEXS617

    Measured: Predose up to 24 hours postdose

  4. Area under Plasma Concentration Curve From Time Zero to the Last Quantifiable Concentration (AUC0-inf) of GTAEXS617

    Measured: Predose up to 24 hours postdose

  5. Duration of Response (DOR)

    Measured: Up to 2 years

  6. Progression-Free Survival (PFS)

    Measured: Up to 2 years

  7. Disease Control Rate (DCR)

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start6 Jul 2023
  3. Primary completionJan 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05985655
Sponsor's protocol ID
GTAEXS617-001
Acronym
ELUCIDATE
Status last verified
Aug 2026
First submitted
25 Jul 2023
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GTAEXS617 and SoC in people with Head and Neck Squamous Cell Carcinoma (HNSCC) and Pancreatic Adenocarcinoma, run by Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. at 15 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, United Kingdom, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. (385-374-1724, clinicaltrials@recursionpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05985655.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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