Lung Cancer Clinical Trial

CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab

Summary

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.

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Full Description

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

View Eligibility Criteria

Eligibility Criteria

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 progressed during treatment with an anti-PD-1/PD-L1 therapy and had confirmation of PD>=4 weeks later. 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.

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

140

Study ID:

NCT03123783

Recruitment Status:

Completed

Sponsor:

Apexigen America, Inc.

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There are 21 Locations for this study

See Locations Near You

University of Arizona Cancer Center
Tucson Arizona, 85724, United States
City of Hope
Duarte California, 91010, United States
Yale University
New Haven Connecticut, 06520, United States
Hem-Onc Associates of the Treasure Coast
Port Saint Lucie Florida, 32952, United States
University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC)
Baltimore Maryland, 21201, United States
Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
SUNY Upstate Medical Hospital
Syracuse New York, 13210, United States
University Hospitals Seidman Cancer Center
Cleveland Ohio, 44106, United States
Abramson Cancer Center of The University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Fox Chase Center
Rockledge Pennsylvania, 19046, United States
Tennessee Oncology
Nashville Tennessee, 37203, United States
Hospital Quirón Dexeus
Barcelona , 08028, Spain
H. Vall d'Hebron
Barcelona , 08035, Spain
H. Clinic i Provincial
Barcelona , 08036, Spain
H. Insular de Gran Canaria
Las Palmas De Gran Canaria , , Spain
H. Lucus Augusti
Lugo , 27003, Spain
H. Doce de Octubre
Madrid , 28041, Spain
H. HM Sanchinnarro
Madrid , 28050, Spain
H. de Málaga
Málaga , 29010, Spain
H. General de Valencia
Valencia De Alcántara , 46014, Spain
H. La Fe
Valencia , 46014, Spain

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

140

Study ID:

NCT03123783

Recruitment Status:

Completed

Sponsor:


Apexigen America, Inc.

How clear is this clinincal trial information?

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