7 completed, 3 terminated, 1 active not recruiting, 1 suspended. 9 Phase 1, 8 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 9 | Completed 5, Terminated 2, Active not recruiting 1, Suspended 1 |
| Phase 2 | 8 | Completed 4, Terminated 2, Suspended 1, Withdrawn 1 |
Follow APX005M: new trials by email Literature Review of APX005M trials Research Report on APX005M
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| APX005M in Patients With Recurrent Ovarian Cancer APX005M - Ovarian Cancer | Phase 2 | Withdrawn | Nordic Society of Gynaecological Oncology - Clinical Trials Unit | 2023-09-07 | 2023-09-11 | |
| Switch Maintenance in Pancreatic ZIMBERELIMAB, DOMVANALIMAB, APX005M - Pancreatic Cancer, Adenocarcinoma of the Pancreas | Phase 1 / Phase 2 | Suspended | James Cleary, MD, PhD | 46 | 2022-11-30 | 2026-06-04 |
| A Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma (RCC) Nivolumab, Ipilimumab, APX005M - Advanced Melanoma, Renal Cell Carcinoma | Phase 1 | Completed | Yale University | 26 | 2020-09-14 | 2026-06-11 |
| A Study to Evaluate Sotigalimab (APX005M) in Subjects With Unresectable or Metastatic Melanoma sotigalimab - Unresectable Melanoma, Metastatic Melanoma | Phase 2 | Terminated | Apexigen America, Inc. | 45 | 2019-06-12 | 2024-02-13 |
| APX005M and Doxorubicin in Advanced Sarcoma Doxorubicin, APX005M - Soft Tissue Sarcoma | Phase 2 | Completed | Alexander Z. Wei, MD | 27 | 2019-03-20 | 2026-06-10 |
| A Personal Cancer Vaccine (NEO-PV-01) and APX005M or Ipilimumab With Nivolumab in Patients With Advanced Melanoma NEO-PV-01, Nivolumab, Adjuvant - Metastatic Melanoma | Phase 1 | Terminated | BioNTech US Inc. | 22 | 2018-10-08 | 2020-09-03 |
| APX005M With Nivolumab and Cabiralizumab in Advanced Melanoma, Non-small Cell Lung Cancer or Renal Cell Carcinoma APX005M, Cabiralizumab, Nivolumab - Advanced Melanoma, Non-small Cell Lung Cancer | Phase 1 | Completed | Yale University | 42 | 2018-06-09 | 2024-07-03 |
| APX005M With Concurrent Chemoradiation for Resectable Esophageal and Gastroesophageal Junction Cancers APX005M, Radiation Therapy, Paclitaxel - Esophageal Cancer, GastroEsophageal Cancer | Phase 2 | Completed | Apexigen America, Inc. | 34 | 2017-10-06 | 2024-05-02 |
| Safety and Efficacy of APX005M With Gemcitabine and Nab-Paclitaxel With or Without Nivolumab in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma APX005M, Nivolumab, Nab-Paclitaxel - Metastatic Pancreatic Adenocarcinoma | Phase 1 / Phase 2 | Completed | Parker Institute for Cancer Immunotherapy | 129 | 2017-07-21 | 2022-12-23 |
| CD40 Agonistic Antibody APX005M (Sotigalimab) in Combination With Nivolumab APX005M, Nivolumab - Cancer, Non Small Cell Lung Cancer Metastatic | Phase 1 / Phase 2 | Completed | Apexigen America, Inc. | 140 | 2017-07-10 | 2023-12-26 |
| APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma APX005M, Pembrolizumab - Melanoma | Phase 1 / Phase 2 | Terminated | M.D. Anderson Cancer Center | 34 | 2017-06-02 | 2025-11-21 |
| Personalized Peptide Vaccine in Treating Patients With Advanced Pancreatic Cancer or Colorectal Cancer Imiquimod, Pembrolizumab, Sotigalimab - Metastatic Colorectal Adenocarcinoma, Metastatic Pancreatic Ductal Adenocarcinoma | Phase 1 | Active not recruiting | M.D. Anderson Cancer Center | 119 | 2016-05-11 | 2026-10-13 |
| Study of the CD40 Agonistic Monoclonal Antibody APX005M APX005M - Cancer, NSCLC | Phase 1 | Completed | Apexigen America, Inc. | 43 | 2015-05-01 | 2023-12-20 |
Melanoma (5) · Neoplasms (3) · Carcinoma, Renal Cell (2) · Carcinoma, Non-Small-Cell Lung (1) · Carcinoma, Transitional Cell (1) · Colorectal Neoplasms (1) · Esophageal Neoplasms (1) · Head and Neck Neoplasms (1) · Leiomyosarcoma (1) · Liposarcoma (1) · Lung Neoplasms (1) · Neurofibrosarcoma (1) · Ovarian Neoplasms (1) · Pancreatic Neoplasms (1) · Sarcoma (1)
Apexigen America, Inc. (4) · M.D. Anderson Cancer Center (2) · Yale University (2) · Alexander Z. Wei, MD (1) · BioNTech US Inc. (1) · James Cleary, MD, PhD (1) · Nordic Society of Gynaecological Oncology - Clinical Trials Unit (1) · Parker Institute for Cancer Immunotherapy (1)
United States (11) · Spain (2) · Denmark (1) · Poland (1)
Harriet Kluger, MD (2) · Adi Diab, MD (1) · Alexander Wei, MD (1) · James Cleary, MD, PhD (1) · Kelly Olino, MD (1) · Mansoor R Mirza (1) · Mark DeMario, MD (1) · Michael J Overman (1) · Sarah Weiss, MD (1)
PMID 33387490, PMID 34140403, PMID 35662283, PMID 37964379, PMID 39907035
P50CA121974 (1)