Study to Assess GTAEXS617 in Patients With Advanced Solid Tumors
About the study
A phase 1/2 study to assess the safety, tolerability, pharmacokinetics and anti-tumor activity of GTAEXS617-001 in patients with advanced solid tumors.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Advanced Solid Tumor
Age (in years)
18+
Phase
PHASE1/PHASE2
Participants Needed
170
Est. Completion Date
May 31, 2028
Treatment Type
INTERVENTIONAL
Sponsor
Exscientia AI Limited
ClinicalTrials.gov NCT Identifier
NCT05985655
Study Number
GTAEXS617-001
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