CD40 Agonistic Antibody APX005M in Combination With Nivolumab
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| ClinicalTrials.gov Identifier: NCT03123783 |
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Recruitment Status :
Completed
First Posted : April 21, 2017
Last Update Posted : December 8, 2021
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Sponsor:
Apexigen America, Inc.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Apexigen America, Inc.
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cancer Non Small Cell Lung Cancer Metastatic Metastatic Melanoma Neoplasm of Lung Melanoma | Drug: APX005M Drug: Nivolumab | Phase 1 Phase 2 |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 140 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Intervention Model Description: | 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. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | July 10, 2017 |
| Actual Primary Completion Date : | November 16, 2020 |
| Actual Study Completion Date : | November 16, 2020 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Melanoma
Drug Information
available for:
Nivolumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Phase 1b escalation
Non-small cell lung cancer (NSCLC) or metastatic melanoma APX005M escalated from 0.03 to 0.1 to 0.3 mg/kg and nivolumab 360 mg every 3 weeks |
Drug: APX005M
APX005M is a CD40 agonistic monoclonal antibody Drug: Nivolumab Nivolumab is an immune checkpoint (PD-1) blocking antibody
Other Name: Opdivo |
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Experimental: Phase 2 expansion Cohort 1
Immunotherapy naïve, metastatic or locally advanced NSCLC APX005M 0.3 mg/kg and nivolumab 360 mg every 3 weeks |
Drug: APX005M
APX005M is a CD40 agonistic monoclonal antibody Drug: Nivolumab Nivolumab is an immune checkpoint (PD-1) blocking antibody
Other Name: Opdivo |
|
Experimental: 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 |
Drug: APX005M
APX005M is a CD40 agonistic monoclonal antibody Drug: Nivolumab Nivolumab is an immune checkpoint (PD-1) blocking antibody
Other Name: Opdivo |
|
Experimental: Phase 2 expansion Cohort 3
Metastatic or locally advanced NSCLC progressing during treatment with anti-PD-1/PD-L1:
APX005M 0.3 mg/kg and nivolumab 360 mg every 3 weeks |
Drug: APX005M
APX005M is a CD40 agonistic monoclonal antibody Drug: Nivolumab Nivolumab is an immune checkpoint (PD-1) blocking antibody
Other Name: Opdivo |
Primary Outcome Measures :
- Incidence of dose limiting toxicities [ Time Frame: Up to 21 days following first dose of APX005M and nivolumab ]Incidence of dose limiting toxicities in Phase 1
- Incidence of adverse events [ Time Frame: Through up to approximately 4 weeks following last dose of APX005M and/or nivolumab ]Incidence of adverse events throughout the study
- Objective response rate [ Time Frame: Every 8 weeks up to approximately 1 year following first dose of APX005M and nivolumab ]Objective response rate according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Secondary Outcome Measures :
- Blood concentrations of APX005M [ Time Frame: Predose, end of infusion, 4, 24, 48 and 168 hours following first and third dose of APX005M ]Blood concentrations of APX005M
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03123783
Locations
Show 23 study locations
Sponsors and Collaborators
Apexigen America, Inc.
Bristol-Myers Squibb
Investigators
| Study Director: | Medical Director | Apexigen America, Inc. |
| Responsible Party: | Apexigen America, Inc. |
| ClinicalTrials.gov Identifier: | NCT03123783 |
| Other Study ID Numbers: |
APX005M-002 |
| First Posted: | April 21, 2017 Key Record Dates |
| Last Update Posted: | December 8, 2021 |
| Last Verified: | December 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Apexigen America, Inc.:
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CD40 Immunotherapy Nivolumab APX005M PD-1 |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Melanoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas Nivolumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |