Phase 1/1b Study to Evaluate the Safety and Tolerability of Ciforadenant Alone and in Combination With Atezolizumab in Advanced Cancers

Not Recruiting

Trial ID: NCT02655822

Purpose

This is a phase 1/1b open-label, multicenter, dose-selection study of ciforadenant, an oral small molecule targeting the adenosine-A2A receptor on T-lymphocytes and other cells of the immune system. This trial will study the safety, tolerability, and anti-tumor activity of ciforadenant as a single agent and in combination with atezolizumab, a PD-L1 inhibitor against various solid tumors. Ciforadenant blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumor activity of T cells and other immune cells.

Official Title

A Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, Dose-Selection Study of Ciforadenant as Single Agent and in Combination With Atezolizumab in Patients With Selected Incurable Cancers

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Sandy Srinivas
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)

Eligibility


Renal Cell Carcinoma Inclusion Criteria

   1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.

   2. Documented pathologic diagnosis of clear cell RCC.

   3. Relapsed or refractory to 1-2 prior lines of therapy containing at least an
   anti-PD-(L)1 agent.

   4. Measurable disease according to RECIST v1.1

   5. Mandatory newly collected tumor biopsy sample obtained prior to treatment initiation.

Renal Cell Carcinoma Exclusion Criteria

   1. History of severe hypersensitivity reaction to monoclonal antibodies.

   2. Has immunodeficiency or requires treatment with systemic immunosuppressive medication
   within 2 weeks prior to initiation of study treatment or anticipation of need for
   systemic immunosuppressant medication during study treatment.

   3. Has an active autoimmune disease requiring systemic treatment with in the past 2 years
   OR a documented history of clinically severe autoimmune disease.

Metastatic Castration-Resistant Prostate Cancer Inclusion Criteria

   1. Documentation of disease: progressive CRPC with histologically or cytologically
   confirmed adenocarcinoma of the prostate.

   2. Patients must have radiologically evident metastatic disease, but it can be measurable
   or non-measurable disease:

      - Measurable disease: nodal, visceral, or extra nodal lesions according to RECIST
      v1.1 using a diagnostic computed tomography

      - Non-measurable disease: bone only disease (up to 1/3 of study population) per
      PCWG3 criteria

   3. 1-3 prior lines of therapy, including at least one newer generation androgen synthesis
   inhibitor (e.g., abiraterone) or androgen receptor antagonist (e.g., enzalutamide,
   apalutamide, darolutamide).

   4. Mandatory newly collected tumor biopsy sample obtained prior to treatment initiation.

   5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.

Metastatic Castration-Resistant Prostate Cancer Exclusion Criteria

   1. Has pure small-cell histology and variants with predominant (≥ 50%) neuroendocrine
   differentiation.

   2. Has a history of severe hypersensitivity reaction to monoclonal antibodies.

   3. Has immunodeficiency or requires treatment with systemic immunosuppressive medication
   within 2 weeks prior to initiation of study treatment or anticipation of need for
   systemic immunosuppressant medication during study treatment.

   4. Has an active autoimmune disease requiring systemic treatment with in the past 2 years
   OR a documented history of clinically severe autoimmune disease.

Intervention(s):

drug: Ciforadenant

drug: Ciforadenant

drug: Ciforadenant

drug: Ciforadenant + atezolizumab

drug: Ciforadenant

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Melanie Ashland
650-723-0669

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