MedPath

Sotigalimab

Generic Name
Sotigalimab
Drug Type
Biotech
CAS Number
2305607-45-6
Unique Ingredient Identifier
JEA93WJ5DG
Background

Sotigalimab is under investigation in clinical trial NCT03123783 (CD40 Agonistic Antibody APX005M in Combination With Nivolumab).

Switch Maintenance in Pancreatic

Phase 1
Recruiting
Conditions
Pancreatic Cancer
Adenocarcinoma of the Pancreas
Squamous Cell Carcinoma of Pancreas
Adenosquamous Carcinoma of the Pancreas
Interventions
First Posted Date
2022-06-15
Last Posted Date
2025-01-22
Lead Sponsor
James Cleary, MD, PhD
Target Recruit Count
46
Registration Number
NCT05419479
Locations
🇺🇸

Dana Farber Cancer Institute, Boston, Massachusetts, United States

APX005M in Patients With Recurrent Ovarian Cancer

Phase 2
Withdrawn
Conditions
Ovarian Cancer
Interventions
First Posted Date
2022-01-21
Last Posted Date
2023-09-11
Lead Sponsor
Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Registration Number
NCT05201001
Locations
🇩🇰

NSGO-CTU, Copenhagen, Sjaelland, Denmark

A Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma (RCC)

Phase 1
Active, not recruiting
Conditions
Advanced Melanoma
Renal Cell Carcinoma
Interventions
First Posted Date
2020-07-31
Last Posted Date
2025-02-05
Lead Sponsor
Yale University
Target Recruit Count
26
Registration Number
NCT04495257
Locations
🇺🇸

Yale New Haven Hospital, New Haven, Connecticut, United States

🇺🇸

Yale Cancer Center, New Haven, Connecticut, United States

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

Phase 2
Terminated
Conditions
Cancer
Cancer of Skin
Melanoma
Unresectable Melanoma
Metastatic Melanoma
Melanoma (Skin)
Interventions
First Posted Date
2020-04-08
Last Posted Date
2024-02-13
Lead Sponsor
Apexigen America, Inc.
Target Recruit Count
45
Registration Number
NCT04337931
Locations
🇵🇱

Centrum Onkologii - Instytutu im. Marii Skłodowskiej - Curie w Warszawie, Warsaw, Poland

🇵🇱

Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu, Poznan, Poland

🇪🇸

Hospital Universitari Vall D'Hebron, Barcelona, Spain

and more 16 locations

APX005M and Doxorubicin in Advanced Sarcoma

Phase 2
Active, not recruiting
Conditions
Soft Tissue Sarcoma
Interventions
First Posted Date
2018-10-25
Last Posted Date
2025-04-29
Lead Sponsor
Alexander Z. Wei, MD
Target Recruit Count
27
Registration Number
NCT03719430
Locations
🇺🇸

City of Hope, Duarte, California, United States

🇺🇸

Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, United States

🇺🇸

Columbia University Irving Medical Center/NYP, New York, New York, United States

APX005M With Nivolumab and Cabiralizumab in Advanced Melanoma, Non-small Cell Lung Cancer or Renal Cell Carcinoma

Phase 1
Completed
Conditions
Non-small Cell Lung Cancer
Advanced Melanoma
Renal Cell Carcinoma
Interventions
First Posted Date
2018-04-18
Last Posted Date
2024-07-03
Lead Sponsor
Yale University
Target Recruit Count
42
Registration Number
NCT03502330
Locations
🇺🇸

Yale Cancer Center, New Haven, Connecticut, United States

Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma

Phase 1
Completed
Conditions
Metastatic Pancreatic Adenocarcinoma
Interventions
First Posted Date
2017-07-11
Last Posted Date
2022-12-23
Lead Sponsor
Parker Institute for Cancer Immunotherapy
Target Recruit Count
129
Registration Number
NCT03214250
Locations
🇺🇸

University of California, Los Angeles, Los Angeles, California, United States

🇺🇸

M.D. Anderson Cancer Center, Houston, Texas, United States

🇺🇸

Stanford University, Stanford, California, United States

and more 4 locations

APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers

Phase 2
Completed
Conditions
Esophageal Cancer
GastroEsophageal Cancer
Interventions
Radiation: Radiation Therapy
Procedure: Surgical resection of tumor
First Posted Date
2017-05-24
Last Posted Date
2024-05-02
Lead Sponsor
Apexigen America, Inc.
Target Recruit Count
34
Registration Number
NCT03165994
Locations
🇺🇸

Wake Forest School of Medicine, Winston-Salem, North Carolina, United States

🇺🇸

University of Cincinnati Medical Center, Cincinnati, Ohio, United States

🇺🇸

Renovatio Clinical, The Woodlands, Texas, United States

and more 7 locations

CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab

Phase 1
Completed
Conditions
Metastatic Melanoma
Non Small Cell Lung Cancer Metastatic
Melanoma
Cancer
Neoplasm of Lung
Interventions
First Posted Date
2017-04-21
Last Posted Date
2023-12-26
Lead Sponsor
Apexigen America, Inc.
Target Recruit Count
140
Registration Number
NCT03123783
Locations
🇪🇸

H. Doce de Octubre, Madrid, Spain

🇪🇸

H. Vall d'Hebron, Barcelona, Spain

🇪🇸

H. Lucus Augusti, Lugo, Spain

and more 20 locations

APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma

Phase 1
Active, not recruiting
Conditions
Melanoma
Interventions
First Posted Date
2016-03-11
Last Posted Date
2024-12-12
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
32
Registration Number
NCT02706353
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

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