4 completed, 3 active not recruiting, 2 recruiting, 2 terminated. 7 Phase 1, 5 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 7 | Active not recruiting 3, Completed 3, Recruiting 1 |
| Phase 2 | 5 | Completed 2, Terminated 2, Recruiting 1 |
Follow CDX-301: new trials by email Literature Review of CDX-301 trials Research Report on CDX-301
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 |
|---|---|---|---|---|---|---|
| In Situ Immunomodulation With CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients w/ Unresectable and Metastatic Solid Tumors Anti-CD40 Agonist Monoclonal Antibody CDX-1140, Poly ICLC, Radiation Therapy - Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma | Phase 1 | Active not recruiting | University of Southern California | 14 | 2023-01-09 | 2026-06-18 |
| CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer PLD Chemotherapy, CDX-1140, CDX-301 - HER2-negative Breast Cancer, Metastatic Breast Cancer | Phase 1 | Recruiting | University of Texas Southwestern Medical Center | 30 | 2022-04-20 | 2026-06-17 |
| The Safety and Tolerability of PGV001-based Personalized Multi-peptide Vaccines in the Adjuvant Setting. PGV-001, Poly-ICLC, CDX-301 - Prostate Cancer | Phase 1 | Active not recruiting | Ashutosh Kumar Tewari | 27 | 2022-01-05 | 2026-01-07 |
| NeoVax + CDX-301 and Nivolumab or Pembrolizumab in Melanoma CDX-301, NEOVAX, Nivolumab - Melanoma, Metastatic Melanoma | Phase 1 | Active not recruiting | Dana-Farber Cancer Institute | 10 | 2022-01-03 | 2026-03-25 |
| Immunologic Effects of CDX-301 and CDX-1140 in Resectable Pancreatic Cancer Patients CDX-301, CDX-1140, Research blood draw - Pancreatic Cancer, Cancer of the Pancreas | Phase 2 | Terminated | Washington University School of Medicine | 16 | 2021-08-13 | 2024-10-08 |
| Converting HR+ Breast Cancer Into an Individualized Vaccine Focal Radiation therapy, Pembrolizumab (200mg IV for 30 minutes, CDX-301 - Breast Cancer | Phase 2 | Recruiting | Weill Medical College of Cornell University | 100 | 2020-03-17 | 2026-01-28 |
| Vaccination With Flt3L, Radiation, and Poly-ICLC Pembrolizumab, Flt3L, Radiation - Non-Hodgkin's Lymphoma, Metastatic Breast Cancer | Phase 1 / Phase 2 | Completed | Icahn School of Medicine at Mount Sinai | 17 | 2019-04-05 | 2026-05-22 |
| A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies CDX-1140, CDX-301, pembrolizumab - Melanoma, Non-small Cell Lung Cancer | Phase 1 | Completed | Celldex Therapeutics | 132 | 2017-12-01 | 2024-03-28 |
| A Safety and Tolerability Study of CDX-301 With or Without Plerixafor for Stem Cell Mobilization in Matched Related Allogeneic Donor/Recipient Sibling Transplant Pairs CDX-301, CDX-301 and plerixafor - For Donors, Related Donors Giving Peripheral Blood Stem Cells (PBSC) to a Sibling | Phase 2 | Terminated | Celldex Therapeutics | 36 | 2014-07-01 | 2017-04-07 |
| A Vaccine (CDX-1401) With or Without a Biologic Drug (CDX-301) for the Treatment of Patients With Stage IIB-IV Melanoma DEC-205/NY-ESO-1 Fusion Protein CDX-1401, Poly ICLC, Recombinant Flt3 Ligand - Cutaneous Melanoma, Melanoma | Phase 2 | Completed | National Cancer Institute (NCI) | 60 | 2014-04-09 | 2021-11-16 |
| A Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers CDX-301 - Healthy | Phase 1 | Completed | Celldex Therapeutics | 30 | 2011-10-01 | 2017-06-27 |
Breast Neoplasms (5) · Melanoma (4) · Lymphoma, Non-Hodgkin (3) · Pancreatic Neoplasms (2) · Bile Duct Neoplasms (1) · Bone Neoplasms (1) · Carcinoma (1) · Carcinoma, Basal Cell (1) · Carcinoma, Merkel Cell (1) · Carcinoma, Non-Small-Cell Lung (1) · Carcinoma, Renal Cell (1) · Cholangiocarcinoma (1) · Colorectal Neoplasms (1) · Esophageal Neoplasms (1) · Fallopian Tube Neoplasms (1)
Celldex Therapeutics (3) · Ashutosh Kumar Tewari (1) · Dana-Farber Cancer Institute (1) · Icahn School of Medicine at Mount Sinai (1) · National Cancer Institute (NCI) (1) · University of Southern California (1) · University of Texas Southwestern Medical Center (1) · Washington University School of Medicine (1) · Weill Medical College of Cornell University (1)
United States (11)
Ashutosh Tewari, MD (1) · Dara Lundon, MD MSc MBA PhD (1) · Fumito Ito, MD (1) · Joshua Brody, MD (1) · Nina Bhardwaj (1) · Patrick A Ott, MD, PhD (1) · Roheena Z Panni, M.D. (1) · Sangeetha Reddy (1) · Silvia Formenti, M.D. (1) · Sujit S Nair, Ph.D. (1)
K08CA267189 (1), P30CA015704 (1), R01CA262506 (1), U01CA154967 (1)