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A Study to Evaluate APX005M in Subjects With Unresectable or Metastatic Melanoma

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ClinicalTrials.gov Identifier: NCT04337931
Recruitment Status : Recruiting
First Posted : April 8, 2020
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
Apexigen, Inc.

Brief Summary:
This is a multicenter, open label, Phase 2 study, with 3 parallel cohorts. The aim of the study is to evaluate the efficacy of APX005M administered at 2 different schedules to adult subjects with unresectable or metastatic melanoma. Subjects who have not received prior immunotherapy will be alternately assigned to 1 of 2 cohorts (2 different APX005M administration schedules) as long as both are open. Subjects who have failed approved immunotherapy regimens will be assigned to a 3rd cohort of APX005M in combination with radiation therapy.

Condition or disease Intervention/treatment Phase
Unresectable Melanoma Metastatic Melanoma Drug: APX005M Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Multicenter, Open-label Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody APX005M With or Without Stereotactic Body Radiation in Adults With Unresectable or Metastatic Melanoma
Actual Study Start Date : December 16, 2019
Estimated Primary Completion Date : August 12, 2022
Estimated Study Completion Date : November 12, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Cohort 1
APX005M every 3 weeks
Drug: APX005M
2 different administration schedules per treatment cycle
Other Name: Infusion

Experimental: Cohort 2
APX005M every 2 weeks
Drug: APX005M
2 different administration schedules per treatment cycle
Other Name: Infusion

Experimental: Cohort 3
APX005M every 2 weeks plus radiation therapy
Drug: APX005M
2 different administration schedules per treatment cycle
Other Name: Infusion




Primary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: 12 months ]
    CR + PR (RECIST 1.1)


Secondary Outcome Measures :
  1. Incidence and severity of AEs and specific laboratory abnormalities [ Time Frame: 12 months ]
  2. ORR by iRECIST [ Time Frame: 12 months ]
  3. Duration of Response [ Time Frame: 12 months ]


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

  • Histologically or cytologically confirmed unresectable or metastatic melanom
  • Measurable disease by RECIST 1.1
  • Subjects with BRAF activating mutation must have received a BRAF inhibitor and/or MEK inhibitor regimen prior to study entry

Exclusion

  • Use of systemic corticosteroids or other systemic immunosuppressive drugs within the 28 days prior to first dose of investigational product (except inhaled corticosteroids) History of allogeneic bone marrow transplantation
  • Active, known or suspected autoimmune disease
  • Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
  • History of (non-infectious) pneumonitis that required corticosteroids or current pneumonitis
  • History of interstitial lung disease

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): NCT04337931


Locations
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Poland
Maria Sklodowska-Curie National Research Institute of Oncology Recruiting
Warsaw, Poland
Contact: Piotr Rutkowski    48 22 546 21 03    rutkowskip@coi.waw.pl   
Spain
H. Quirón Dexeus Recruiting
Barcelona, Spain
Contact: María González Cao    9354 0135    mgonzalezcao@oncorosell.com   
H. Vall d'Hebron Recruiting
Barcelona, Spain
Contact: Eva Muñoz    +34 274 60 00 ext 4350    emunoz@vhio.net   
H. Insular de Gran Canaria Recruiting
Las Palmas De Gran Canaria, Spain
Contact: Delvys Rodríguez    661 672 235    delvysra@yahoo.com   
H. Virgen de la Arrixaca Recruiting
Murcia, Spain
Contact: Pablo Cerezuela    666496774    pcerezuelaf@seom.org   
H. R. U. de Málaga Recruiting
Málaga, Spain
Contact: Miguel Berciano, MD    34 951 291 425    migueberci@gmail.com   
Clinica Universitaria de Navarra Recruiting
Pamplona, Spain
Contact: María Esperanza Rodriguez Ruiz, MD    34 948 255 400    mrruiz@unav.es   
Hospital Universitario Marqués De Valdecilla Recruiting
Santander, Spain
Contact: Mª Almudena Garcia    34 942 20 25 25    almudena.garcia@scsalud.es   
H. U. de Canarias Recruiting
Tenerife, Spain
Contact: Juana Oramas    922 678 204    juanaoramas@gmail.com   
Fundación Instituto Valenciano De Oncología Recruiting
Valencia, Spain
Contact: Mª José de Juan, MD    34 961 114 008    mjuanfi81@hotmail.com   
H. U. Dr. Peset Recruiting
Valencia, Spain
Contact: Sebastian Ochenduszko, MD    34 963 189 169    sebaochenduszko@gmail.com   
C. H. U.de Vigo Recruiting
Vigo, Spain
Contact: MªJosé Villanueva, MD    34 986 825 830    maria.jose.villanueva.silva@sergas.es   
H. U. Miguel Servet Recruiting
Zaragoza, Spain
Contact: Teresa Puertolas, MD    34 976 359 268    tjpuertolas@gmail.com   
Sponsors and Collaborators
Apexigen, Inc.
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Responsible Party: Apexigen, Inc.
ClinicalTrials.gov Identifier: NCT04337931    
Other Study ID Numbers: APX005M-010
First Posted: April 8, 2020    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas