Status:
RECRUITING
Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors
Lead Sponsor:
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Conditions:
Advanced Solid Tumor
Head and Neck Squamous Cell Carcinoma (HNSCC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617-001 in participants with advanced solid tumors.
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
July 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT05985655
Start Date
July 6 2023
End Date
May 1 2028
Last Update
September 5 2025
Active Locations (12)
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1
START Midwest
Grand Rapids, Michigan, United States, 49546
2
START San Antonio
San Antonio, Texas, United States, 78229
3
START Mountain Region
West Valley City, Utah, United States, 84119
4
GZA Ziekenhuizen - Campus Sint-Augustinus
Antwerp, Belgium