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Trial Title:
Study to Assess GTAEXS617 in Patients With Advanced Solid Tumors
NCT ID:
NCT05985655
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
GTAEXS617
Description:
GTAEXS617 tablets daily
Arm group label:
GTAEXS617
Summary:
A phase 1/2 study to assess the safety, tolerability, pharmacokinetics and anti-tumor
activity of GTAEXS617-001 in patients with advanced solid tumors.
Detailed description:
A phase 1/2 study to assess the safety, tolerability, pharmacokinetics and anti-tumor
activity of GTAEXS617-001 as monotherapy and in combination, in patients with one of the
following advanced solid tumors: head and neck squamous cell carcinoma, colorectal
adenocarcinoma, pancreatic adenocarcinoma, non-small cell lung cancer, breast cancer (HR+
and HER2- that has progressed to a prior treatment with CD4/CDK6 inhibitor), ovarian
epithelial carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ECOG performance status 0-1
- Life expectancy >3 months
- One the following histologically or cytologically confirmed advanced solid tumors:
head and neck squamous cell carcinoma, colorectal adenocarcinoma, pancreatic
adenocarcinoma, NSCLC, breast carcinoma (HR+ and HER2- that has progressed to a
prior treatment with CD4/CDK6 inhibitor), or ovarian epithelial carcinoma
- Patients 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
- Participant must have tumor lesion(s) or metastases amenable to biopsy, excluding
bone metastases
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 inhibitors and or 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
- Received treatment with known substrates of organic anion transporting peptide 1B3
(OATP1B3) 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinique Universitaires Saint-Luc
Address:
City:
Brussels
Country:
Belgium
Status:
Recruiting
Investigator:
Last name:
Rachel Galot
Email:
Principal Investigator
Facility:
Name:
CHU Sart Tilman
Address:
City:
Liège
Country:
Belgium
Status:
Recruiting
Investigator:
Last name:
Laurence Lousberg
Email:
Principal Investigator
Facility:
Name:
The Beatson West of Scotland Cancer Centre
Address:
City:
Glasgow
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Jeff Evans
Email:
Principal Investigator
Facility:
Name:
UCL Hospitals NHS Foundation Trust
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Martin Forster
Email:
Principal Investigator
Facility:
Name:
The Christie NHS Foundation Trust
Address:
City:
Manchester
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Donna Graham
Email:
Principal Investigator
Facility:
Name:
Newcastle Upon Tyne NHS Foundation Trust
Address:
City:
Newcastle Upon Tyne
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Elizabeth Ruth Plummer
Email:
Principal Investigator
Facility:
Name:
Oxford University Hospitals NHS Foundation Trust
Address:
City:
Oxford
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Simon Lord
Email:
Principal Investigator
Start date:
July 6, 2023
Completion date:
May 2028
Lead sponsor:
Agency:
Exscientia AI Limited
Agency class:
Industry
Collaborator:
Agency:
GT Apeiron LLC
Agency class:
Other
Source:
Exscientia AI Limited
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05985655
