Status:
TERMINATED
Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Squamous Cell Carcinoma of Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
There are two main goals of this study: The first is to find the highest safe dose of REGN6569 when given with cemiplimab. The second is to get some initial information about how well the REGN6569 in ...
Eligibility Criteria
Inclusion
- Key
- Dose escalation cohorts: Advanced stage (unresectable or metastatic) solid tumor malignancy, confirmed histologically or cytologically as defined in the protocol
- Dose expansion cohorts: Advanced stage (unresectable or metastatic) head and neck squamous cell carcinoma (HNSCC), confirmed histologically or cytologically. Patients must have evidence of progression on anti-Programmed death-1 (receptor)/Programmed death ligand 1 (PD-1/PD-L1) blockade either as monotherapy or in combination with other therapies, as defined in the protocol
- Mandatory biopsies: Able and willing to provide tumor tissue at baseline and while on treatment, with at least 1 soft tissue lesion amenable to biopsy by ultrasound or computed tomography (CT)-guided biopsy or under direct visualization as defined in the protocol
- Key
Exclusion
- Has previously received GITR-targeted therapy
- Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy as defined in the protocol
- Has any condition that requires ongoing/continuous corticosteroid therapy (\>10 mg prednisone/day or anti-inflammatory equivalent) within 14 days prior to the first dose of study therapy
- Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol
- Has a known history of, or any evidence of, interstitial lung disease, or active, non-infectious pneumonitis in the past 5 years. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to first dose of study therapy
- Has uncontrolled infection with human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency
- Has received a live vaccine within 4 weeks of planned start of study medication. For dose escalation only: Has received a COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study.
- Has had prior allogeneic stem cell transplantation or received organ transplants at any time, or autologous stem cell transplantation
- Has a history of malignancy within 2 years of date of first planned dose on study as defined in the protocol
- Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Key Trial Info
Start Date :
October 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2025
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04465487
Start Date
October 5 2020
End Date
February 7 2025
Last Update
February 24 2025
Active Locations (10)
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1
Angeles Clinic and Research Institute - Clinic/Outpatient Facility
Los Angeles, California, United States, 90025
2
H.Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
START South Texas Accelerated Research Therapeutics
Grand Rapids, Michigan, United States, 49503