Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CDX-585 · 1 trial · 14 indications
The rates of drug-related adverse events will be summarized, and maximum tolerated dose will be determined.
The rates of drug-related adverse events will be summarized, and further evaluated in specific tumor types.
| Arm | Type | Description |
|---|---|---|
| CDX-585 | EXPERIMENTAL | Dose-escalation phase: Eligible patients will receive treatment, based on cohort assigned, in 2-week cycles until progression or intolerance. Expansion phase: Patients enrolled in the expansion phase of the study will receive CDX-585 at the dose level chosen during the escalation phase. |
| Name | Type | Description |
|---|---|---|
| CDX-585 | DRUG | CDX-585 is administered by infusion every 2 weeks |
Key Inclusion Criteria: 1. Recurrent, locally advanced, or metastatic solid tumor cancer excluding primary central nervous system tumors (e.g., glioblastoma). 2. Receipt of standard therapy for the tumor type in the recurrent, locally advanced, or metastatic setting. 3. Measurable (target) disease ...
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CDX-585 is an investigational small molecule being studied in adults with advanced solid tumors, including non-small cell lung cancer. It was evaluated in a Phase 1 study that also enrolled patients with gastric, head and neck, ovarian, bladder, colorectal, esophageal, renal, pancreatic, and other advanced malignancies.
CDX-585 targets ILT4 and PD-1, two immune checkpoint proteins. By binding both targets, the small molecule is designed to act on pathways that regulate immune cell activity in the tumor microenvironment. Both ILT4 and PD-1 belong to the immune checkpoint class of therapeutic targets.
CDX-585 is being developed by Celldex Therapeutics, Inc., which trades on the Nasdaq under the ticker CLDX. The company sponsored the Phase 1 study of the compound in patients with advanced malignancies.
CDX-585 has been in Phase 1 clinical development. Its single registered trial, a Phase 1 study in advanced malignancies, is listed as completed. The drug is investigational and has not been approved by the FDA for any indication.
CDX-585 was studied in one registered clinical trial, NCT05788484, titled A Study of CDX-585 in Patients With Advanced Malignancies. The Phase 1 trial enrolled 20 participants in the United States and is listed as completed. It was an uncontrolled study without randomization or blinding.