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.
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
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Adenocarcinoma, Non-small Cell Lung Cancer (NSCLC)
- 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
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.
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- 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
15 sites in 3 countries
United States6 sites, 6 recruiting
- 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
United Kingdom5 sites, 5 recruiting
- 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
Belgium4 sites, 4 recruiting
- 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
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.
- 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)
- 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 group | Role | What they receive |
|---|---|---|
| Phase 1: Dose Escalation Monotherapy | Experimental | Participants will receive GTAEXS617 oral tablets in increasing doses. Receives: Drug: GTAEXS617 |
| Phase 1: Dose Escalation Combination Therapy | Experimental | Participants 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 Monotherapy | Experimental | Participants will receive GTAEXS617 oral tablets at Recommended Phase 2 Dose (RP2D). Receives: Drug: GTAEXS617 |
| Phase 2: Dose Expansion Combination Therapy | Experimental | Participants 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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 2 years
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
Measured: Up to 28 days
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)
Phase 1: ORR as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: Up to 2 years
Maximum Plasma Concentration (Cmax) of GTAEXS617
Measured: Predose up to 24 hours postdose
Time Maximum Plasma Concentration (Tmax) of GTAEXS617
Measured: Predose up to 24 hours postdose
Area under Plasma Concentration Curve From Time Zero to the Last Quantifiable Concentration (AUC0-inf) of GTAEXS617
Measured: Predose up to 24 hours postdose
Duration of Response (DOR)
Measured: Up to 2 years
Progression-Free Survival (PFS)
Measured: Up to 2 years
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.
- First posted14 Aug 2023
- Study start6 Jul 2023
- Primary completionJan 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell Carcinoma (HNSCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Exscientia AI Ltd.
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