OncoMatch/Clinical Trials/NCT05985655
Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors
Is NCT05985655 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including GTAEXS617 and SoC for head and neck squamous cell carcinoma (hnscc).
Treatment: GTAEXS617 · SoC — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Head and Neck Squamous Cell Carcinoma
Pancreatic Cancer
Non-Small Cell Lung Carcinoma
Ovarian Cancer
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: CDK4 prior inhibitor therapy
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
Required: CDK6 prior inhibitor therapy
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
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anticancer therapy
Exception: allowed if >28 days or >5 half-lives before first dose
Received anticancer therapy within 28 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment
Lab requirements
Blood counts
adequate hematological function
Kidney function
adequate renal function
Liver function
adequate liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- START Midwest · Grand Rapids, Michigan
- START San Antonio · San Antonio, Texas
- START Mountain Region · West Valley City, Utah
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05985655 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anticancer therapy disqualifies patients from enrollment.
Does this trial require CDK4?
Yes, CDK4 prior inhibitor therapy is a required biomarker for enrollment.
Does this trial require CDK6?
Yes, CDK6 prior inhibitor therapy is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify