CD40 Agonistic Antibody APX005M in Combination With Nivolumab



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Skin Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:July 10, 2017
End Date:August 2020
Contact:Apexigen, Inc.
Email:info@apexigen.com
Phone:650.931.6236

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A Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody APX005M Administered in Combination With Nivolumab in Subjects With Non-small Cell Lung Cancer and Subjects With Metastatic Melanoma

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.

APX005M-002 is an open-label Phase 1-2 study and comprises a dose-escalation portion (Phase
1) followed by a Phase 2 tumor specific portion.

Eligible subjects with non-small cell lung cancer or metastatic melanoma will receive
intravenous APX005M in combination with nivolumab until disease progression, unacceptable
toxicity or death, whichever occurs first.

Study objectives include:

- Determine the maximum tolerated dose and the recommended phase 2 dose of APX005M when
given in combination with nivolumab

- Evaluate safety of the APX005M and nivolumab combination

- Evaluate the objective response rate, duration of response and median PFS by RECIST 1.1
in subjects with non-small cell lung cancer or metastatic melanoma receiving APX005M in
combination with nivolumab

- Determine the PK of APX005M

Inclusion Criteria:

- Histologically or cytologically confirmed, immunotherapy naïve or PD-1/PD-L1
pre-treated, metastatic or locally advanced non-small cell lung cancer not amenable to
curative treatment. Subjects may be treatment naive or could have received one prior
platinum based chemotherapy for non-small cell lung cancer and subjects with a
documented activating mutation (e.g., EGFR, ALK, ROS) must also have received the
appropriate therapy and progressed

- Histologically or cytologically confirmed unresectable or metastatic melanoma that had
confirmed 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 any immunomodulatory agents (e.g., anti- CD40, anti-PD-1/PD-L1,
anti-CTLA-4, IDO inhibitors) except PD-1/PD-L1 targeting agents in the subsets of
patients that must have previous treatment with anti-PD-1/PD-L1 therapy

- Second malignancy (solid or hematologic) within the past 3 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 or NSCLC.
We found this trial at
12
sites
250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Athens, Georgia 30607
Phone: 706-353-2990
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Duarte, California 91010
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New Haven, Connecticut 6520
(203) 432-4771
Phone: 203-815-4124
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Omaha, Nebraska 68114
Phone: 402-691-6971
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Omaha, NE
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Phone: 402-559-8711
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Phone: 215-614-1813
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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Philadelphia, Pennsylvania 19111
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1871 Southeast Tiffany Avenue
Port Saint Lucie, Florida 34952
Phone: 772-408-5159
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Port Saint Lucie, FL
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Tucson, Arizona 85724
Phone: 520-626-0375
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