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Clinical Trial 20821

Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT04465487

Phase: Phase I
Principal Investigator: Khong, Hung

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Overview

Study Title

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

Summary

There are two main goals of this study. The first is to find the highest safe dose of REGN6569 when given alone and with cemiplimab. The second is to get some initial information about how well the REGN6569 and cemiplimab combination may help to shrink tumors in certain types of cancer.

Objective

For dose escalation cohorts, the primary objective is to evaluate the safety and tolerability of REGN6569 as monotherapy lead-in and in combination with cemiplimab. For dose expansion cohorts, the co-primary objectives are:  To assess the preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by objective response rate (ORR)  To assess the preliminary pharmacodynamic activity of REGN6569 as lead-in monotherapy, as measured by intratumoral GITR+ Treg depletion For dose escalation cohorts, the secondary objectives are:  To assess preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by ORR, disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS)  To characterize the pharmacokinetics (PK) of REGN6569 alone and in combination with cemiplimab  To assess the immunogenicity of REGN6569 and cemiplimab For expansion cohorts, the secondary objectives are:  To characterize the safety profile in each expansion cohort  To assess preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by DCR, DOR, PFS, and OS  To characterize the PK of REGN6569 alone and in combination with cemiplimab  To assess the immunogenicity of REGN6569 and cemiplimab

Treatments

Therapies

Immunotherapy

Medications

Cemiplimab (); REGN2810 (Cemiplimab); REGN6569 ()

Inclusion Criteria

  • 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, confirmed histologically or cytologically as defined in the protocol. Patient resides ex-US in a region for which anti-PD1/PD-L1 is not approved or not available for first line recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) and has not received prior-anti PD1/PD-L1 therapy.
  • 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 .CT-guided biopsy or under direct visualization
  • All Cohorts:
  • Has no prior history of immune checkpoint blockade (ICB) therapy
  • Has exhausted all approved available treatment options for their disease, (other than anti-PD1 therapy for second line HNSCC cancer), with no other with no standard therapy likely to convey clinical benefit as defined in the protocol

  • Exclusion Criteria

  • 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
  • Note: Other protocol-defined Inclusion/ Exclusion criteria apply

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