Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Phase
Phase 1/2
Started
2023-07-06
Last updated
2026-08-13
Condition(s) studied
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)
Investigational drug(s) / intervention(s)
GTAEXS617SoC
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.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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 1.1 — Up to 2 years
Trial sites (15)
Facility
City
Region
Status
USC Norris Comprehensive Cancer Center
Los Angeles
California
Recruiting
START Midwest
Grand Rapids
Michigan
Recruiting
Memorial Sloan Kettering Cancer Center
New York
New York
Recruiting
The Ohio State University
Columbus
Ohio
Recruiting
START San Antonio
San Antonio
Texas
Recruiting
START Mountain Region
West Valley City
Utah
Recruiting
GZA Ziekenhuizen - Campus Sint-Augustinus
Antwerp
Belgium
Recruiting
Clinique Universitaires Saint-Luc
Brussels
Belgium
Recruiting
Institute Jules Bordet
Brussels
Belgium
Recruiting
CHU Sart Tilman
Liège
Belgium
Recruiting
The Beatson West of Scotland Cancer Centre
Glasgow
United Kingdom
Recruiting
UCL Hospitals NHS Foundation Trust
London
United Kingdom
Recruiting
The Christie NHS Foundation Trust
Manchester
United Kingdom
Recruiting
Newcastle Upon Tyne NHS Foundation Trust
Newcastle upon Tyne
United Kingdom
Recruiting
Oxford University Hospitals NHS Foundation Trust
Oxford
United Kingdom
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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