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

Primary Purpose

Unresectable Melanoma, Metastatic Melanoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
APX005M
Sponsored by
Apexigen America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unresectable Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maria Sklodowska-Curie National Research Institute of Oncology
  • H. Quirón Dexeus
  • H. Vall d'Hebron
  • H. Insular de Gran Canaria
  • H. Virgen de la Arrixaca
  • H. R. U. de Málaga
  • Clinica Universitaria de Navarra
  • Hospital Universitario Marqués De Valdecilla
  • H. U. de Canarias
  • Fundación Instituto Valenciano De Oncología
  • H. U. Dr. Peset
  • C. H. U.de Vigo
  • H. U. Miguel Servet

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

APX005M every 3 weeks

APX005M every 2 weeks

APX005M every 2 weeks plus radiation therapy

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
Complete Response + Partial Response (RECIST 1.1)

Secondary Outcome Measures

Incidence and severity of Adverse Events and specific laboratory abnormalities
ORR by iRECIST (immunotherapy Response Evaluation Criteria)
Duration of Response

Full Information

First Posted
March 30, 2020
Last Updated
August 29, 2023
Sponsor
Apexigen America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04337931
Brief Title
A Study to Evaluate Sotigalimab (APX005M) in Subjects With Unresectable or Metastatic Melanoma
Official Title
A Phase II Multicenter, Open-label Study to Evaluate the Safety and Efficacy of the CD40 Agonistic Antibody Sotigalimab (APX005M) With or Without Stereotactic Body Radiation Therapy in Adults With Unresectable or Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
July 29, 2022 (Actual)
Study Completion Date
August 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apexigen America, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Melanoma, Metastatic Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
APX005M every 3 weeks
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
APX005M every 2 weeks
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
APX005M every 2 weeks plus radiation therapy
Intervention Type
Drug
Intervention Name(s)
APX005M
Other Intervention Name(s)
Infusion
Intervention Description
2 different administration schedules per treatment cycle
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
Complete Response + Partial Response (RECIST 1.1)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Incidence and severity of Adverse Events and specific laboratory abnormalities
Time Frame
12 months
Title
ORR by iRECIST (immunotherapy Response Evaluation Criteria)
Time Frame
12 months
Title
Duration of Response
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Histologically or cytologically confirmed unresectable or metastatic melanoma 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
Facility Information:
Facility Name
Maria Sklodowska-Curie National Research Institute of Oncology
City
Warsaw
Country
Poland
Facility Name
H. Quirón Dexeus
City
Barcelona
Country
Spain
Facility Name
H. Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
H. Insular de Gran Canaria
City
Las Palmas De Gran Canaria
Country
Spain
Facility Name
H. Virgen de la Arrixaca
City
Murcia
Country
Spain
Facility Name
H. R. U. de Málaga
City
Málaga
Country
Spain
Facility Name
Clinica Universitaria de Navarra
City
Pamplona
Country
Spain
Facility Name
Hospital Universitario Marqués De Valdecilla
City
Santander
Country
Spain
Facility Name
H. U. de Canarias
City
Tenerife
Country
Spain
Facility Name
Fundación Instituto Valenciano De Oncología
City
Valencia
Country
Spain
Facility Name
H. U. Dr. Peset
City
Valencia
Country
Spain
Facility Name
C. H. U.de Vigo
City
Vigo
Country
Spain
Facility Name
H. U. Miguel Servet
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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