Recruiting
Phase 1
Phase 2

GTAEXS617-001

Sponsor:

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

Code:

NCT05985655

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GTAEXS617

SoC

Study Details

Brief 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.

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

Study ID

NCT05985655

Start date

Jul 6, 2023

Status verified date

Aug, 2026

Completion date

May, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

230 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1: Dose Escalation Monotherapy

Participants will receive GTAEXS617 oral tablets in increasing doses.

experimental: Phase 1: Dose Escalation Combination Therapy

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

experimental: Phase 2: Dose Expansion Monotherapy

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

experimental: Phase 2: Dose Expansion Combination Therapy

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

Interventions

GTAEXS617

Administered as specified in the treatment arm.

SoC

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

Primary outcome measure

  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 2 years ]
  • Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]
  • 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 ]

Central Contacts and Locations

Central contacts

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

385-374-1724clinicaltrials@recursionpharma.com

Locations

USC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90089

START Midwest

Recruiting

Grand Rapids, Michigan, United States, 49546

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

START San Antonio

Recruiting

San Antonio, Texas, United States, 78229

START Mountain Region

Recruiting

West Valley City, Utah, United States, 84119

More Information

Sponsor

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

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • Advanced Solid Tumor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. on 2026-08-13.