Recruiting
Phase 1/2
Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors
Condition(s) studied
Head and Neck Squamous Cell Carcinoma (HNSCC)Pancreatic AdenocarcinomaNon-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 CarcinomaTriple Negative Breast Cancer (TNBC)
Investigational drug(s) / intervention(s)
GTAEXS617SoC
GTAEXS617: Administered as specified in the treatment arm.
SoC: Participants will receive selected SoC regimen (fulvestrant, paclitaxel + bevacizumab, pegylated liposomal doxorubicin, or capecitabine) administered as specified in the treatment arm.
Study 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.
Eligibility
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 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.
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 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.
Primary outcome measure(s)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) — Up to 2 years
- Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) — Up to 28 days
- Phase 2 : Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 — Up to 2 years
Trial sites (15)
| Facility | City | Region | Status |
| USC Norris Comprehensive Cancer Center |
Los Angeles |
California |
Recruiting |
| START Midwest |
Grand Rapids |
Michigan |
Recruiting |
| Memorial Sloan Kettering Cancer Center |
New York |
New York |
Recruiting |
| The Ohio State University |
Columbus |
Ohio |
Recruiting |
| START San Antonio |
San Antonio |
Texas |
Recruiting |
| START Mountain Region |
West Valley City |
Utah |
Recruiting |
| GZA Ziekenhuizen - Campus Sint-Augustinus |
Antwerp |
Belgium |
Recruiting |
| Clinique Universitaires Saint-Luc |
Brussels |
Belgium |
Recruiting |
| Institute Jules Bordet |
Brussels |
Belgium |
Recruiting |
| CHU Sart Tilman |
Liège |
Belgium |
Recruiting |
| The Beatson West of Scotland Cancer Centre |
Glasgow |
United Kingdom |
Recruiting |
| UCL Hospitals NHS Foundation Trust |
London |
United Kingdom |
Recruiting |
| The Christie NHS Foundation Trust |
Manchester |
United Kingdom |
Recruiting |
| Newcastle Upon Tyne NHS Foundation Trust |
Newcastle upon Tyne |
United Kingdom |
Recruiting |
| Oxford University Hospitals NHS Foundation Trust |
Oxford |
United Kingdom |
Recruiting |
More Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. trials in the UK
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