CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Apexigen America, Inc.
Study ID
NCT03123783
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • APX005M — DRUG
    APX005M is a CD40 agonistic monoclonal antibody
  • Nivolumab — DRUG
    Nivolumab is an immune checkpoint (PD-1) blocking antibody

Study Details

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.

Key Dates

Start date
Jul 10, 2017
Status verified
Dec 2023
Primary completion
Nov 16, 2020
Completion
Nov 16, 2020

Study Design

Enrollment
140 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Experimental: 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
  • Experimental: 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
  • 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
  • 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
  • Experimental: 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

Primary Outcome Measure

Number of Participants Experiencing Dose-limiting Toxicities (DLTs) [ Time Frame: Up to 21 days following first dose of APX005M and nivolumab ]

Locations (13)

FacilityCityStateZIPSite coordinators
University of Arizona Cancer CenterTucsonArizona85724-
City of HopeDuarteCalifornia91010-
Yale UniversityNew HavenConnecticut06520-
Hem-Onc Associates of the Treasure CoastPort Saint LucieFlorida32952-
University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC)BaltimoreMaryland21201-
Nebraska Cancer SpecialistsOmahaNebraska68130-
University of Nebraska Medical CenterOmahaNebraska68198-
SUNY Upstate Medical HospitalSyracuseNew York13210-
University Hospitals Seidman Cancer CenterClevelandOhio44106-
Abramson Cancer Center of The University of PennsylvaniaPhiladelphiaPennsylvania19104-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Fox Chase CenterRockledgePennsylvania19046-
Tennessee OncologyNashvilleTennessee37203-

Find similar trials in Tucson, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of Arizona Cancer Center· Tucson, AZCity of Hope· Duarte, CAYale University· New Haven, CTHem-Onc Associates of the Treasure Coast· Port Saint Lucie, FLUniversity of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center (UMGCCC)· Baltimore, MDNebraska Cancer Specialists· Omaha, NE

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