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.
Title
- Brief Title: CD40 Agonistic Antibody APX005M in Combination With Nivolumab
- 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
Clinical Trial IDs
- ORG STUDY ID:
APX005M-002
- NCT ID:
NCT03123783
Conditions
- Cancer
- Non Small Cell Lung Cancer Metastatic
- Metastatic Melanoma
- Neoplasm of Lung
- Melanoma
Interventions
Drug | Synonyms | Arms |
---|
APX005M | | APX005M in combination with nivolumab |
Nivolumab | Opdivo | APX005M in combination with nivolumab |
Purpose
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
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
Trial Arms
Name | Type | Description | Interventions |
---|
APX005M in combination with nivolumab | Experimental | Subjects will receive intravenously APX005M in combination with nivolumab until disease progression, unacceptable toxicity or death. | |
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 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of dose limiting toxicities |
Time Frame: | Up to 21 days following first dose of APX005M and nivolumab |
Safety Issue: | |
Description: | Incidence of dose limiting toxicities in Phase 1 |
Secondary Outcome Measures
Measure: | Blood concentrations of APX005M |
Time Frame: | Predose, end of infusion, 4, 24, 48 and 168 hours following first and third dose of APX005M |
Safety Issue: | |
Description: | Blood concentrations of APX005M |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | Apexigen, Inc. |
Trial Keywords
- CD40
- Immunotherapy
- Nivolumab
- APX005M
- PD-1
Last Updated
May 4, 2021