Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors
About the study
Who can take part
INCLUSION CRITERIA
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 Cluster of Differentiation 4 [CD4] / Cyclin-Dependent Kinase 6 [CDK6] inhibitor), or platinum-resistant high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers (HGSOC).
- 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.
EXCLUSION CRITERIA
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 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.
Note: Other protocol Inclusion/Exclusion criteria may apply.
Study Locations
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How to Apply
Study Details
Contition
Advanced Solid Tumor,Head and Neck Squamous Cell Carcinoma (HNSCC),Pancreatic Adenocarcinoma,Non-small Cell Lung Cancer (NSCLC),Breast Carcinoma,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
Age
18+
Phase
PHASE1/PHASE2
Participants Needed
165
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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