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New treatment option for Head and Neck Squamous Cell Carcinoma (HNSCC)
Official title Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05985655
What this study is testing
What is GTAEXS617?
GTAEXS617 is an investigational medicine, being studied as a potential treatment for head and neck squamous cell carcinoma (hnscc).
Also referred to as REC-617.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Must have disease that is advanced (ie, surgery or radiotherapy are not considered to be potentially curative), recurrent, or metastatic following...
- Adequate hematological, liver, and renal function.
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Grand Rapids, Michigan, United States
- San Antonio, Texas, United States
- West Valley City, Utah, United States
- Antwerp, Belgium
- Brussels, Belgium
- Liège, Belgium
- Glasgow, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- Newcastle upon Tyne, United Kingdom
- Oxford, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Grand Rapids, Michigan, United States; San Antonio, Texas, United States; West Valley City, Utah, United States; Antwerp, Belgium; Brussels, Belgium and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.