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Clinical Trial 19654

Cancer Type: Breast
Study Type: Treatment
NCT#: NCT03674827

Phase: Phase I
Prinicipal Investigator:

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Overview

Study Title

A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Doses and Treatment Intensification of a Vaccine-Based Immunotherapy Regimen-2 (VBIR-2) (PF-06936308) for Advanced Non-Small Cell Lung Cancer and Metastatic Triple-Negative Breast Cancer

Summary

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses of a vaccine-based immunotherapy regimen for patients with advanced non-small cell lung cancer and metastatic triple-negative breast cancer.

Objective

Primary Objective(s): Phase 1A - To assess safety and tolerability of increasing dose levels of VBIR-2. - To characterize the dose limiting toxicities (DLTs) and overall safety profile of escalated doses of VBIR-2. - To assess safety and tolerability at increasing dose levels of VBIR-2 components in successive cohorts of patients in order to estimate the Maximum Tolerated Dose (MTD) and select the Recommended Phase 2 Dose RP2D)/schedule. Secondary Objective(s): - To evaluate the immune response elicited by VBIR-2 to the 3 selected tumor-antigens. - To evaluate the PK of tremelimumab and of anti-PD-1 (PF-06801591) after SC administration. - To evaluate the anti-drug antibody (ADA) response of tremelimumab and anti-PD-1 (PF-06801591) after SC administration with the other components. - To evaluate the pharmacodynamic (PD) effects of VBIR-2 by tumor type. - To document any preliminary evidence of anti-tumor activity. Tertiary/Exploratory Objective(s): - To collect banked biospecimens for exploratory research, unless prohibited by local regulations or ethics committee decision.

Treatments

Therapies

Medications

AdC68 (); CP-675,206 (tremelimumab); PF-06801591 (); pDNA (); tremelimumab ()

Inclusion Criteria

  • Histological or cytological diagnosis of non-small cell lung cancer or triple-negative breast cancer
  • Adequate bone marrow, kidney, and liver function

  • Exclusion Criteria

  • ECOG performance status greater than or equal to 2
  • Concurrent immunotherapy
  • History of or active autoimmune disorders (including but not limited to: myasthenia gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic lupus, erythematosus, scleroderma) and other conditions that disorganize or alter the immune system.
  • History of inflammatory bowel disease.
  • Current use of any implanted electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.
  • Presence of any surgical or traumatic metal implants at the site of administration

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