Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CDX-301 · 2 trials · 3 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
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. |
| 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) |
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...
CDX-301 is an investigational small molecule being studied for use in melanoma and in healthy volunteers. It is being evaluated in Phase 1 clinical trials, including a study combining it with NeoVax and nivolumab or pembrolizumab in patients with metastatic melanoma.
CDX-301 targets CD27, a protein involved in immune cell signaling. By targeting CD27, CDX-301 may modulate immune responses, which is relevant to its investigation in melanoma and as a potential immunotherapeutic agent.
CDX-301 is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CLDX. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and potential efficacy.
CDX-301 is in Phase 1 clinical development. It is not yet approved by the FDA and remains investigational. Two Phase 1 trials have been conducted: one completed in healthy volunteers and one active but not recruiting in melanoma patients.
CDX-301 has been studied in two Phase 1 trials. NCT01465139 evaluated CDX-301 in healthy volunteers and is completed. NCT04930783 is an active, not recruiting trial combining CDX-301 with NeoVax and nivolumab or pembrolizumab in patients with metastatic melanoma.
Yes, CDX-301 is also known as rhuFlt3L, as indicated in the title of the completed healthy volunteer trial NCT01465139. This alternative name refers to the recombinant human Flt3 ligand, which is the active component of CDX-301.