APX005M

DRUG11 trials

Sponsors

Apexigen America, Inc., M.D. Anderson Cancer Center, Parker Institute for Cancer Immunotherapy, Yale University, BioNTech US Inc.

Conditions

Adenocarcinoma of the PancreasAdenosquamous Carcinoma of the PancreasAdvanced MelanomaCancerEsophageal CancerGastroEsophageal CancerHead and Neck CancerMSI-H

Phase 1

Study of the CD40 Agonistic Monoclonal Antibody APX005M

CompletedNCT02482168

Apexigen America, Inc.Cancer, Head and Neck Cancer, Melanoma +3

Start: 2015-05-31End: 2018-06-19Updated: 2023-12-20

APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma

TerminatedNCT02706353

M.D. Anderson Cancer CenterMelanoma

Start: 2017-06-02End: 2025-03-10Updated: 2025-11-21

CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab

CompletedNCT03123783

Apexigen America, Inc.Cancer, Melanoma, Metastatic Melanoma +2

Start: 2017-07-10End: 2020-11-16Updated: 2023-12-26

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

CompletedNCT03214250

Parker Institute for Cancer ImmunotherapyMetastatic Pancreatic Adenocarcinoma

Start: 2017-07-21End: 2022-02-25Updated: 2022-12-23

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

CompletedNCT03502330

Yale UniversityAdvanced Melanoma, Non-small Cell Lung Cancer, Renal Cell Carcinoma

Start: 2018-06-09End: 2024-05-15Updated: 2024-07-03

A Personal Cancer Vaccine (NEO-PV-01) and APX005M or Ipilimumab With Nivolumab in Patients With Advanced Melanoma

TerminatedNCT03597282

BioNTech US Inc.Metastatic Melanoma

Start: 2018-10-08End: 2020-08-11Updated: 2020-09-03

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

Active, not recruitingNCT04495257

Yale UniversityAdvanced Melanoma, Renal Cell Carcinoma

Start: 2020-09-14End: 2026-08-28Updated: 2025-10-30

Switch Maintenance in Pancreatic

SuspendedNCT05419479

James Cleary, MD, PhDAdenocarcinoma of the Pancreas, Adenosquamous Carcinoma of the Pancreas, Pancreatic Cancer +1

Start: 2022-11-30End: 2028-09-30Target: 46Updated: 2026-02-24

Phase 2

APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers

CompletedNCT03165994

Apexigen America, Inc.Esophageal Cancer, GastroEsophageal Cancer

Start: 2017-10-06End: 2023-02-21Updated: 2024-05-02

APX005M and Doxorubicin in Advanced Sarcoma

Active, not recruitingNCT03719430

Alexander Z. Wei, MDSoft Tissue Sarcoma

Start: 2019-03-20End: 2026-12-31Updated: 2025-04-29

APX005M in Patients With Recurrent Ovarian Cancer

WithdrawnNCT05201001

Nordic Society of Gynaecological Oncology - Clinical Trials UnitOvarian Cancer

Start: 2023-09-07End: 2023-09-07Updated: 2023-09-11

Related Papers

A Phase 2 Study of Sotigalimab, a CD40 Agonist Antibody, plus Concurrent Chemoradiation as Neoadjuvant Therapy for Esophageal and Gastroesophageal Junction Cancers

Cancer Research Communications2025-02-014 citations

Abstract C007: Quemliclustat (CD73 Inhibitor) reduces adenosine-regulated NR4A gene expression and increases mPDAC inflammation in patients from the ARC-8 trial

Cancer Research2024-09-152 citations

Abstract PR-20: Hepcidin-mediated iron sequestration limits CD8+ tumor infiltrating lymphocytes in pancreas adenocarcinoma

Cancer Research2024-09-15

Circulating KRAS G12D but not G12V is associated with survival in metastatic pancreatic ductal adenocarcinoma

Nature Communications2024-07-098 citations

A bedside to bench study of anti-PD-1, anti-CD40, and anti-CSF1R indicates that more is not necessarily better.

2023-11-149 citations

1361 Neoadjuvant CD40 agonism remodels the tumor immune microenvironment in locally advanced esophageal/gastroesophageal junction cancer

Regular and Young Investigator Award Abstracts2023-10-31

A phase II trial with safety lead-in to evaluate the addition of sotigalimab, a CD40 agonistic monoclonal antibody, to standard-of-care doxorubicin for the treatment of advanced sarcoma.

Journal of Clinical Oncology2023-06-011 citations

Clinical benefit of granulocyte-colony stimulating factor (GCSF) use during chemoimmunotherapy treatment for metastatic pancreatic adenocarcinoma (mPDAC).

Journal of Clinical Oncology2023-01-24

782 Intratumoral sotigalimab with pembrolizumab activates antigen-presenting cells and induces local and distant anti-tumor responses in first-line metastatic melanoma: results of a phase I/II study

Regular and Young Investigator Award Abstracts2022-11-013 citations

602 Mass spectrometry-based protein biomarker analysis in chemoimmunotherapy combinations identifies unique immune signatures in pancreatic cancer

Regular and Young Investigator Award Abstracts2022-11-012 citations

Sotigalimab and/or nivolumab with chemotherapy in first-line metastatic pancreatic cancer: clinical and immunologic analyses from the randomized phase 2 PRINCE trial

Nature Medicine2022-06-01309 citations

Circulating <i>KRAS</i> variant-specific shedding and association with survival in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) receiving chemoimmunotherapy.

Journal of Clinical Oncology2022-06-011 citations

Distinct biosignatures associate with survival after chemoimmunotherapy in a randomized, three-arm phase II study in patients with metastatic pancreatic cancer.

Journal of Clinical Oncology2022-06-01

Feasibility and utility of synthetic control arms derived from real-world data to support clinical development.

Journal of Clinical Oncology2022-01-194 citations

389 Phase II of CD40 agonistic antibody sotigalimab (APX005M) in combination with nivolumab in subjects with metastatic melanoma with confirmed disease progression on anti-PD-1 therapy

Regular and Young Investigator Award Abstracts2021-11-018 citations

343 Multiomic biomarker signatures identify subsets of patients who may benefit from either nivolumab or sotigalimab in combination with chemotherapy in metastatic pancreatic cancer

Regular and Young Investigator Award Abstracts2021-11-011 citations

A Phase I Study of APX005M and Cabiralizumab with or without Nivolumab in Patients with Melanoma, Kidney Cancer, or Non–Small Cell Lung Cancer Resistant to Anti-PD-1/PD-L1

Clinical Cancer Research2021-06-1790 citations

Novel induction of CD40 expression by tumor cells with RAS/RAF/PI3K pathway inhibition augments response to checkpoint blockade.

2021-06-0634 citations

Gemcitabine (Gem) and nab-paclitaxel (NP) ± nivolumab (nivo) ± CD40 agonistic monoclonal antibody APX005M (sotigalimab), in patients (Pts) with untreated metastatic pancreatic adenocarcinoma (mPDAC): Phase (Ph) 2 final results.

Journal of Clinical Oncology2021-05-2023 citations

Baseline level and early on-treatment clearance of circulating mutant <i>KRAS</i> in metastatic pancreatic ductal adenocarcinoma treated with chemotherapy with or without immunotherapy.

Journal of Clinical Oncology2021-05-201 citations

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