Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CDX-301 · 3 trials · 4 indications
Based on the CTEP Active Version (version 5.0) of the NCI Common Terminology Criteria for Adverse Events (CTCAE).
Highest dose of CDX-301 that did not cause a dose limiting toxicity
An AE is any event that either occurs after the initiation of study drug, having been absent at baseline, or, if present at baseline, appears to have worsened in severity or frequency, regardless of its relation to the drug. An SAE is any AE that suggests a significant hazard, contraindication, side effect, or untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Investigators recorded AEs during each participant interaction. Prior to initiation of study drug, only SAEs that were related to a protocol-mandated intervention were recorded. The AE row includes all participants who experienced at least one AE, including SAEs.
The number of adverse events along with the results of vital sign measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of CDX301.
| Arm | Type | Description |
|---|---|---|
| CDX-301 + Neovax + Nivolumab | EXPERIMENTAL | * Participants will have vaccine made from tissue collected from metastatic tumor biopsy or surgical resection, or from previously collected archival biopsy or surgical tissue. * Participants will receive Nivolumab at a flat dose every 4 weeks up to two years. * Participants will receive CDX-301 at a predetermined dose dependent on the number of participants previously enrolled for 5 days starting 2 days before the initiation of NeoVax. CDX-301 will then be administered at a predetermined dose dependent on the number of participants previously enrolled 2 days before and for 5 days coinciding with the administration of NeoVax on days 50 and 78. |
| CDX-301 + Neovax + Pembrolizumab | EXPERIMENTAL | * Participants will have vaccine made from tissue collected from tumor biopsy, or from previously collected archival biopsy or surgical tissue. * Participants will receive neoadjuvant Pembrolizumab for 3 doses every 3 weeks, then undergo standard-of-care surgical resection. * Participants will receive adjuvant NeoVax and CDX-301. CDX-301 will be administered at a predetermined dose, dependent on the number of participants previously enrolled, for 5 days starting 2 days before the initiation of NeoVax. CDX-301 will then be administered at a predetermined dose dependent on the number of participants previously enrolled 2 days before and for 5 days coinciding with the administration of NeoVax on days 50 and 78. * Participants will receive adjuvant Pembrolizumab for 15 doses every 6 weeks. |
| Cohort A: NKTR-214 + Nivolumab | EXPERIMENTAL | - |
| Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab | EXPERIMENTAL | - |
| Cohort C: CDX-301 + INO-5151 + Nivolumab | EXPERIMENTAL | - |
| CDX-301 | EXPERIMENTAL | CDX-301 (rhuFlt3L), administered to healthy patients. |
| Name | Type | Description |
|---|---|---|
| CDX-301 | DRUG | Administered as an injection given underneath the skin |
| NEOVAX | BIOLOGICAL | Personalized neoantigen vaccine administered as an injection given underneath the skin |
| Nivolumab | DRUG | Administered intravenously (IV) |
| Pembrolizumab | DRUG | Administered intravenously (IV) |
| NKTR-214 (Cohort A) | DRUG | NKTR-214 will be administered intravenously every 3 weeks for up to 2 years |
| Nivolumab (Cohort A, B and C) | DRUG | Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C. |
| Stereotactic body radiation therapy (SBRT) (Cohort B) | RADIATION | Radiation therapy will be administered at 30 - 50 Gy in 1 - 5 doses, starting on Day 1 or 2 of Cycle 1 |
| CDX-301 (Cohort B and C) | DRUG | CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C. |
| Poly-ICLC (Cohort B) | DRUG | Poly-ICLC will be administered intramuscularly twice weekly for 3 weeks starting on Day 1 of Cycle 1 |
| INO-5151 (Cohort C) | DRUG | INO-5151 will be administered intramuscularly on Day 8 of the Immune-priming Lead-in, and on day 1 of Cycle 1, 2 and 3, then every 12 weeks thereafter |
| Cellectra 2000 | DEVICE | Electroporation device |
Inclusion Criteria: Eligibility to participate will be assessed at one timepoint: prior to initial core needle/surgical biopsy (Initial Registration). * Inclusion Criteria * Participant is willing and able to give written informed consent * Participants must have histologically confirmed stag...
Top 20 of 52 competitors
CDX-301 is an investigational Phase 1 agent developed by Celldex Therapeutics, Inc. (ticker CLDX) for oncology indications. It is being studied in melanoma and metastatic castration-resistant prostate cancer. CDX-301 is also referred to as CDX-301 (Cohort B and C) in certain study contexts.
CDX-301 is being studied in melanoma, including metastatic melanoma, and in metastatic castration-resistant prostate cancer. It is an investigational therapy and is not approved for any indication. Clinical testing has been conducted in both cancer patients and healthy volunteers.
CDX-301 targets FLT3, a receptor tyrosine kinase. It acts as an agonist at this target, meaning it activates FLT3 signaling rather than blocking it. This agonist activity is the basis for its investigation in oncology settings.
CDX-301 is developed by Celldex Therapeutics, Inc., which trades under the ticker CLDX. The company is the sponsor of the clinical programs evaluating CDX-301 in melanoma and metastatic castration-resistant prostate cancer.
CDX-301 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 program includes completed and active studies, with a total of 43 participants enrolled across the reported trials.
CDX-301 has been evaluated in Phase 1 trials including NCT04930783, which studies NeoVax plus CDX-301 with nivolumab or pembrolizumab in melanoma, and NCT03835533, a completed platform study in metastatic castration-resistant prostate cancer. An earlier completed Phase 1 study, NCT01465139, evaluated CDX-301 in healthy volunteers.