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RecruitingNCT05985655ELUCIDATEUpdated Aug 13, 2026

Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

A Phase 1/2 interventional study of GTAEXS617 and SoC in Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Adenocarcinoma and Non-small Cell Lung Cancer (NSCLC), sponsored by Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.. Recruiting at 15 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 3 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
230
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • 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)

Keywords

  • Advanced Solid Tumor
03

In context

Squamous Cell Carcinoma of Head and Neck

1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.

This study's planned enrollment of 230 is above the median of 49 across 1,432 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.

Browse Squamous Cell Carcinoma of Head and Neck studies →

Lead sponsor

Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
230 participants (estimated)

Study arms

  • Experimental
    Phase 1: Dose Escalation Monotherapy

    Participants will receive GTAEXS617 oral tablets in increasing doses.

    Drug: GTAEXS617

  • Experimental
    Phase 1: Dose Escalation Combination Therapy

    Participants will receive GTAEXS617 oral tablets in increasing doses in combination with standard of care (SoC) treatment.

    Drug: GTAEXS617 · Drug: SoC

  • Experimental
    Phase 2: Dose Expansion Monotherapy

    Participants will receive GTAEXS617 oral tablets at Recommended Phase 2 Dose (RP2D).

    Drug: GTAEXS617

  • Experimental
    Phase 2: Dose Expansion Combination Therapy

    Participants will receive GTAEXS617 oral tablets at RP2D in combination with SoC treatment.

    Drug: GTAEXS617 · Drug: SoC

Interventions

  • DrugGTAEXS617

    Administered as specified in the treatment arm.

    Also known as: REC-617

  • DrugSoC

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

06

What researchers measure

Primary outcomes

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

    Time frame: Up to 2 years

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

    Time frame: Up to 28 days

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

    Time frame: Up to 2 years

Secondary outcomes

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

    Time frame: Up to 2 years

  2. Maximum Plasma Concentration (Cmax) of GTAEXS617

    Time frame: Predose up to 24 hours postdose

  3. Time Maximum Plasma Concentration (Tmax) of GTAEXS617

    Time frame: Predose up to 24 hours postdose

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

    Time frame: Predose up to 24 hours postdose

  5. Duration of Response (DOR)

    Time frame: Up to 2 years

  6. Progression-Free Survival (PFS)

    Time frame: Up to 2 years

  7. Disease Control Rate (DCR)

    Time frame: Up to 2 years

07

Study locations

15 of 15 sites recruiting
  • USC Norris Comprehensive Cancer Center
    Los Angeles, California 90089, United States
    Recruiting
  • START Midwest
    Grand Rapids, Michigan 49546, United States
    Recruiting
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
    Recruiting
  • The Ohio State University
    Columbus, Ohio 43210, United States
    Recruiting
  • START San Antonio
    San Antonio, Texas 78229, United States
    Recruiting
  • START Mountain Region
    West Valley City, Utah 84119, United States
    Recruiting
  • GZA Ziekenhuizen - Campus Sint-Augustinus
    Antwerp, Belgium
    Recruiting
  • Clinique Universitaires Saint-Luc
    Brussels, Belgium
    • Rachel Galot · Principal investigator
    Recruiting
  • Institute Jules Bordet
    Brussels, Belgium
    Recruiting
  • CHU Sart Tilman
    Liège, Belgium
    • Laurence Lousberg · Principal investigator
    Recruiting
  • The Beatson West of Scotland Cancer Centre
    Glasgow, United Kingdom
    • Jeff Evans · Principal investigator
    Recruiting
  • UCL Hospitals NHS Foundation Trust
    London, United Kingdom
    • Martin Forster · Principal investigator
    Recruiting
  • The Christie NHS Foundation Trust
    Manchester, United Kingdom
    • Donna Graham · Principal investigator
    Recruiting
  • Newcastle Upon Tyne NHS Foundation Trust
    Newcastle upon Tyne, United Kingdom
    • Elizabeth Ruth Plummer · Principal investigator
    Recruiting
  • Oxford University Hospitals NHS Foundation Trust
    Oxford, United Kingdom
    • Simon Lord · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05985655
Lead sponsor
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Aug 14, 2023
Start date
Jul 6, 2023
Primary completion
Jan 2028 (estimated)
Completion
May 2028 (estimated)
Last update
Aug 13, 2026

Study contacts

Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Contact
clinicaltrials@recursionpharma.com
385-374-1724
Medical Director
study director · Exscientia AI Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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