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CompletedPhase 1 / Phase 2NCT03123783
Official study title

CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab

Study 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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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAPX005M and Nivolumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 26, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?23 U.S. locations

Locations may change over time.

Who runs it?Apexigen America, Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Apexigen America, Inc.
Interventions being studied
Drug: APX005M; Drug: Nivolumab
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Treatment approach
Immunotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of Arizona Cancer CenterTucson, Arizona
  • City of HopeDuarte, California
  • Yale UniversityNew Haven, Connecticut
  • Hem-Onc Associates of the Treasure CoastPort Saint Lucie, Florida
  • University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC)Baltimore, Maryland
  • Nebraska Cancer SpecialistsOmaha, Nebraska
  • University of Nebraska Medical CenterOmaha, Nebraska
  • SUNY Upstate Medical HospitalSyracuse, New York
  • University Hospitals Seidman Cancer CenterCleveland, Ohio
  • Abramson Cancer Center of The University of PennsylvaniaPhiladelphia, Pennsylvania
  • Fox Chase Cancer CenterPhiladelphia, Pennsylvania
  • Fox Chase CenterRockledge, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 26, 2023. Always confirm current availability with the study team.

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