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CDX-1127 · 1 trial · 10 indications
Analysis 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 CDX-1127.
| Arm | Type | Description |
|---|---|---|
| Hematologic Malignancies (Dose Escalation) | EXPERIMENTAL | B-Cell Enrollment COMPLETED T-Cell Enrollment COMPLETED |
| Solid tumors (Dose Escalation; COMPLETED) | EXPERIMENTAL | - |
| Solid Tumors (Expansion Phase; COMPLETED) | EXPERIMENTAL | Several expansion cohorts of up to 15 patients each are planned, including melanoma and renal cell carcinoma. |
| Hematologic Malignancies (COMPLETED) | EXPERIMENTAL | Several expansion cohorts of up to 15 patients each are planned, including Hodgkin lymphoma. |
| Name | Type | Description |
|---|---|---|
| CDX-1127 | DRUG | Patients will initially receive a single dose of CDX-1127, followed by a 28-day observation period and a Multi-Dose Phase (one "cycle" of 4 weekly doses of CDX-1127). All patients with stable disease who do not experience a DLT or start alternate anti-cancer treatments may then be eligible for a Retreatment Phase (up to 4 additional "cycles"). Patients with confirmed partial response or complete response will be followed for response duration and may be eligible for additional cycles of treatment at the time of relapse/progression. The dose of CDX-1127 given for the Dose Escalation phase will depend on the cohort each patient is assigned to, and will range between 0.1 and 10.0 mg/kg of CDX-1127. |
Inclusion Criteria: Among other criteria, patients must meet the following conditions to be eligible for the study: 1. 18 years of age or older. 2. Body Weight ≤ 120 kg. 3. Histologic diagnosis of either a B-cell or T-cell hematologic malignancy known to express CD27 or one of the following solid ...
CDX-1127 is an investigational drug being studied for the treatment of CD27 expressing B-cell malignancies, such as Hodgkin's lymphoma, as well as other hematologic cancers and select solid tumors. It is in Phase 1 clinical development for these oncology indications.
CDX-1127 targets CD27, a protein expressed on certain B-cell malignancies. By targeting CD27, the drug is designed to interfere with cancer cell signaling, though the exact mechanism of action is not fully detailed in the available information.
CDX-1127 is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CLDX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with certain cancers.
CDX-1127 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and the drug is no longer in active clinical trials according to the available data.
CDX-1127 has been studied in one clinical trial, identified as NCT01460134, titled 'A Study of CDX-1127 (Varlilumab) in Patients With Select Solid Tumor Types or Hematologic Cancers.' This Phase 1 trial was completed and enrolled 90 participants in the United States.
Yes, CDX-1127 is also known as Varlilumab. The clinical trial NCT01460134 refers to the drug as CDX-1127 (Varlilumab), indicating that both names are used interchangeably for the same investigational agent.