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CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab

NCT ID: NCT03123783

Last Updated: 2023-12-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-10

Study Completion Date

2020-11-16

Brief Summary

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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.

Detailed Description

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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

Conditions

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Cancer Non Small Cell Lung Cancer Metastatic Metastatic Melanoma Neoplasm of Lung Melanoma

Keywords

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CD40 Immunotherapy Nivolumab APX005M PD-1

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Phase 1b dose escalation with up to 4 sequential dose levels. Followed by Phase 2 dose expansion at Recommended Phase 2 Dose in 3 parallel disease cohorts.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1b escalation 0.03 mg/kg

Non-small cell lung cancer (NSCLC) or metastatic melanoma

APX005M 0.03 mg/kg and nivolumab 360 mg every 3 weeks

Group Type EXPERIMENTAL

APX005M

Intervention Type DRUG

APX005M is a CD40 agonistic monoclonal antibody

Nivolumab

Intervention Type DRUG

Nivolumab is an immune checkpoint (PD-1) blocking antibody

Phase 1b escalation 0.1 mg/kg

Non-small cell lung cancer (NSCLC) or metastatic melanoma

APX005M 0.1 mg/kg and nivolumab 360 mg every 3 weeks

Group Type EXPERIMENTAL

APX005M

Intervention Type DRUG

APX005M is a CD40 agonistic monoclonal antibody

Nivolumab

Intervention Type DRUG

Nivolumab is an immune checkpoint (PD-1) blocking antibody

Phase 1b escalation 0.3 mg/kg

Non-small cell lung cancer (NSCLC) or metastatic melanoma

APX005M 0.3 mg/kg and nivolumab 360 mg every 3 weeks

Group Type EXPERIMENTAL

APX005M

Intervention Type DRUG

APX005M is a CD40 agonistic monoclonal antibody

Nivolumab

Intervention Type DRUG

Nivolumab is an immune checkpoint (PD-1) blocking antibody

Phase 2 expansion Cohort 1

Immunotherapy naïve, metastatic or locally advanced NSCLC

APX005M 0.3 mg/kg and nivolumab 360 mg every 3 weeks

Group Type EXPERIMENTAL

APX005M

Intervention Type DRUG

APX005M is a CD40 agonistic monoclonal antibody

Nivolumab

Intervention Type DRUG

Nivolumab is an immune checkpoint (PD-1) blocking antibody

Phase 2 expansion Cohort 2

Metastatic melanoma progressing during treatment with anti-PD-1/PD-L1 therapy

APX005M 0.3 mg/kg and nivolumab 360 mg every 3 weeks

Group Type EXPERIMENTAL

APX005M

Intervention Type DRUG

APX005M is a CD40 agonistic monoclonal antibody

Nivolumab

Intervention Type DRUG

Nivolumab is an immune checkpoint (PD-1) blocking antibody

Phase 2 expansion Cohort 3

Metastatic or locally advanced NSCLC progressing during treatment with anti-PD-1/PD-L1:

* Group A: best response of progressive disease or with stable disease \< 16 weeks
* Group B: tumor response or with stable disease ≥ 16 weeks

Group Type EXPERIMENTAL

APX005M

Intervention Type DRUG

APX005M is a CD40 agonistic monoclonal antibody

Nivolumab

Intervention Type DRUG

Nivolumab is an immune checkpoint (PD-1) blocking antibody

Interventions

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APX005M

APX005M is a CD40 agonistic monoclonal antibody

Intervention Type DRUG

Nivolumab

Nivolumab is an immune checkpoint (PD-1) blocking antibody

Intervention Type DRUG

Other Intervention Names

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Opdivo

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Apexigen America, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Pyxis Oncology, Inc

Locations

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University of Arizona Cancer Center

Tucson, Arizona, United States

Site Status

City of Hope

Duarte, California, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

Hem-Onc Associates of the Treasure Coast

Port Saint Lucie, Florida, United States

Site Status

University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC)

Baltimore, Maryland, United States

Site Status

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Site Status

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status

SUNY Upstate Medical Hospital

Syracuse, New York, United States

Site Status

University Hospitals Seidman Cancer Center

Cleveland, Ohio, United States

Site Status

Abramson Cancer Center of The University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase Center

Rockledge, Pennsylvania, United States

Site Status

Tennessee Oncology

Nashville, Tennessee, United States

Site Status

Hospital Quirón Dexeus

Barcelona, , Spain

Site Status

H. Vall d'Hebron

Barcelona, , Spain

Site Status

H. Clinic i Provincial

Barcelona, , Spain

Site Status

H. Insular de Gran Canaria

Las Palmas de Gran Canaria, , Spain

Site Status

H. Lucus Augusti

Lugo, , Spain

Site Status

H. Doce de Octubre

Madrid, , Spain

Site Status

H. HM Sanchinnarro

Madrid, , Spain

Site Status

H. de Málaga

Málaga, , Spain

Site Status

H. La Fe

Valencia, , Spain

Site Status

H. General de Valencia

Valencia de Alcántara, , Spain

Site Status

Countries

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United States Spain

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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APX005M-002

Identifier Type: -

Identifier Source: org_study_id