CD40 Agonistic Antibody APX005M in Combination With Nivolumab

Description

This study is a Phase 1-2 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M administered in combination with nivolumab to adult subjects with non-small cell lung cancer or metastatic melanoma. The Phase 1 portion is intended to establish the maximum tolerated dose and the recommended phase 2 dose of APX005M when administered in combination with nivolumab. The Phase 2 portion of the study will evaluate safety and efficacy of the combination.

Study Start Date

July, 10 2017

Estimated Completion Date

December 2019

Interventions

  • Drug: APX005M
  • Drug: Nivolumab

Study ID

Apexigen, Inc. -- APX005M-002

Status

Unknown

Trial ID

NCT03123783

Study Type

Interventional

Trial Phase

Phase 1/Phase 2

Enrollment Quota

99

Sponsor

Apexigen, Inc.

Inclusion Criteria

  • Histologically or cytologically confirmed immunotherapy na├»ve, metastatic or locally advanced non-small cell lung cancer not amenable to curative treatment. Subjects must have received one prior platinum based chemotherapy for non-small cell lung cancer and subjects with a documented activating mutation (EGFR, ALK or ROS) must also have received the appropriate therapy and progressed
  • Histologically or cytologically confirmed unresectable or metastatic melanoma that had progressive disease during treatment with anti-PD-1/PD-L1 therapy. Subjects with BRAF activating mutation could have also received a BRAF inhibitor and/or MEK inhibitor regimen prior to anti-PD-1/PD-L1 therapy.
  • Measurable disease by RECIST 1.1
  • ECOG performance status of 0 or 1
  • Adequate bone marrow, liver and kidney function
  • Negative pregnancy test for women of child bearing potential
  • Agreement to use effective methods of contraception per the protocol requirements

Exclusion Criteria

  • Previous exposure to anti
  • CD40, CTLA-4, PD-1/PD-L1 or any other immunomodulatory agent (except PD-1/PD-L1 in subjects with metastatic melanoma)
  • Second malignancy (solid or hematologic) within the past 5 years except locally curable cancers that have been apparently cured
  • Active, known, clinically serious infections within the 14 days prior to first dose of investigational product
  • Use of systemic corticosteroids or other systemic immunosuppressive drugs
  • Active, known or suspected autoimmune disease
  • History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis
  • History of interstitial lung disease
  • History of life-threatening toxicity related to prior anti-PD-1/PD-L1 treatment for subjects with metastatic melanoma

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (28)

Study Location Distance Name Phone Email
Yale University - New Haven, Connecticut 18.1 miles Matthew Madura 203-500-0834 matthew.madura@yale.edu
Yale University - New Haven, Connecticut 18.1 miles Matthew Madura 203-500-0834 matthew.madura@yale.edu
Yale University - New Haven, Connecticut 18.1 miles Matthew Madura 203-500-0834 matthew.madura@yale.edu
Yale University - New Haven, Connecticut 18.1 miles Matthew Madura 203-500-0834 matthew.madura@yale.edu
Fox Chase Cancer Center - Philadelphia, Pennsylvania 125.3 miles Linda Thibodeau None Linda.Thibodeau@fccc.edu
Fox Chase Cancer Center - Philadelphia, Pennsylvania 125.3 miles Linda Thibodeau None Linda.Thibodeau@fccc.edu
Fox Chase Cancer Center - Philadelphia, Pennsylvania 125.3 miles Linda Thibodeau None Linda.Thibodeau@fccc.edu
Fox Chase Cancer Center - Philadelphia, Pennsylvania 125.3 miles Linda Thibodeau None Linda.Thibodeau@fccc.edu
Abramson Cancer Center of The University of Pennsylvania - Philadelphia, Pennsylvania 134.5 miles Mary Carberry 215-614-1813 None
Abramson Cancer Center of The University of Pennsylvania - Philadelphia, Pennsylvania 134.5 miles Mary Carberry 215-614-1813 None
Abramson Cancer Center of The University of Pennsylvania - Philadelphia, Pennsylvania 134.5 miles Mary Carberry 215-614-1813 None
Abramson Cancer Center of The University of Pennsylvania - Philadelphia, Pennsylvania 134.5 miles Mary Carberry 215-614-1813 None
Karmanos Cancer Institute - Detroit, Michigan 512.3 miles Amanda Newman 313-576-8411 newmana@karmanos.org
Karmanos Cancer Institute - Detroit, Michigan 512.3 miles Amanda Newman 313-576-8411 newmana@karmanos.org
Karmanos Cancer Institute - Detroit, Michigan 512.3 miles Amanda Newman 313-576-8411 newmana@karmanos.org
Karmanos Cancer Institute - Detroit, Michigan 512.3 miles Amanda Newman 313-576-8411 newmana@karmanos.org
Tennessee Oncology - Nashville, Tennessee 810.5 miles Misty Moore None Misty.Moore@scresearch.net
Tennessee Oncology - Nashville, Tennessee 810.5 miles Misty Moore None Misty.Moore@scresearch.net
Tennessee Oncology - Nashville, Tennessee 810.5 miles Misty Moore None Misty.Moore@scresearch.net
Tennessee Oncology - Nashville, Tennessee 810.5 miles Misty Moore None Misty.Moore@scresearch.net
University of Arizona Cancer Center - Tucson, Arizona 2,164.2 miles KerryAnn Suckra 520-626-0375 kerryanns@email.arizona.edu
University of Arizona Cancer Center - Tucson, Arizona 2,164.2 miles KerryAnn Suckra 520-626-0375 kerryanns@email.arizona.edu
University of Arizona Cancer Center - Tucson, Arizona 2,164.2 miles KerryAnn Suckra 520-626-0375 kerryanns@email.arizona.edu
University of Arizona Cancer Center - Tucson, Arizona 2,164.2 miles KerryAnn Suckra 520-626-0375 kerryanns@email.arizona.edu
City of Hope - Duarte, California 2,472.0 miles Michael Donor None mdonor@coh.org
City of Hope - Duarte, California 2,472.0 miles Michael Donor None mdonor@coh.org
City of Hope - Duarte, California 2,472.0 miles Michael Donor None mdonor@coh.org
City of Hope - Duarte, California 2,472.0 miles Michael Donor None mdonor@coh.org

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