Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies

Squamous Cell Carcinoma of Head and Neck Clinical Trial

Official title:

A Phase 1 Study of REGN6569, an Anti-GITR mAb, With Cemiplimab in Patients With Advanced Solid Tumor Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04465487
• Other study ID #: R6569-ONC-1933
• Secondary ID: 2020-000075-20
• Status: Recruiting
• Phase: Phase 1
• Start date: October 5, 2020
• Est. completion date: June 22, 2026

Study information

• Verified date: December 2023
• Source: Regeneron Pharmaceuticals
• Contact: Clinical Trials Administrator
• Phone: 844-734-6643
• Email: clinicaltrials[@]regeneron.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 combination with cemiplimab may help shrink certain types of cancer.

The study is also looking at:

• Side effects that may be experienced by people taking REGN6569 alone and with cemiplimab

• How REGN6569 and cemiplimab work in the body

• How much REGN6569 and cemiplimab is in your blood

• To see if REGN6569 can lower the number of Treg cells in tumors

• To see if REGN6569 and cemiplimab can shrink tumors when given together

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: June 22, 2026
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

1. Dose escalation cohorts: Advanced stage (unresectable or metastatic) solid tumor malignancy, confirmed histologically or cytologically as defined in the protocol

2. 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

3. 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 Criteria:

1. Has previously received GITR-targeted therapy

2. Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy as defined in the protocol

3. 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

4. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments as defined in the protocol

5. 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

6. Has uncontrolled infection with human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency

7. 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.

8. Has had prior allogeneic stem cell transplantation or received organ transplants at any time, or autologous stem cell transplantation

9. 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

Related Conditions & MeSH terms

• Neoplasms
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• REGN6569
Administered by intravenous (IV) infusion
• Cemiplimab
Administered by IV infusion

Locations

Country	Name	City	State
Spain	Hospital Universitario Vall d'Hebrón	Barcelona
Spain	ICO l'Hospitalet - Hospital Duran i Reynals	Barcelona
Spain	Hospital Universitario Fundacion Jimenez	Madrid
Spain	Hospital Universitario HM Sanchinarro	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	MD Anderson Cancer Center	Madrid
United States	University of Michigan	Ann Arbor	Michigan
United States	START South Texas Accelerated Research Therapeutics	Grand Rapids	Michigan
United States	Angeles Clinic and Research Institute - Clinic/Outpatient Facility	Los Angeles	California
United States	H.Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limited toxicities (DLTs)	Dose escalation period	Up to 42 days
Primary	Incidence and severity of treatment emergent adverse events(TEAEs)	Dose escalation period	Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Primary	Incidence and severity of adverse events of special interest (AESIs)	Dose escalation period	Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Primary	Incidence and severity of serious adverse events (SAEs)	Dose escalation period	Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Primary	Incidence and severity of grade =3 laboratory abnormalities	Dose escalation period	Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Primary	Objective response rate (ORR)	Dose expansion period	Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Primary	Characterize percentage change in intratumoral glucocorticoid-induced tumor necrosis factor receptor-Related (GITR)+ Treg density	Dose expansion period	Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Secondary	ORR	Dose escalation period	Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Secondary	Disease control rate (DCR)	Dose escalation and expansion periods	Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Secondary	Duration of Response (DOR)	Dose escalation and expansion periods	Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Secondary	Progression-free Survival (PFS)	Dose escalation and expansion periods	Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Secondary	Overall survival (OS)	Dose escalation and expansion periods	Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Secondary	Drug concentrations of REGN6569 in serum	Dose escalation and expansion periods	Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Secondary	Drug concentrations of cemiplimab in serum	Dose escalation and expansion periods	Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Secondary	Immunogenicity as measured by anti-drug antibodies (ADA) to REGN6569	Dose escalation and expansion periods	Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Secondary	Immunogenicity as measured by anti-drug antibodies (ADA) to cemiplimab	Dose escalation and expansion periods	Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months