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CDX-585

Phase 1

Non-small Cell Lung Cancer | Small molecule | Oncology |Celldex Therapeutics, Inc.|Last Updated: Jun 15, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

CDX-585 · 1 trial · 14 indications

Phase 1 1
NCT05788484A Study of CDX-585 in Patients With Advanced MalignanciesNon-small Cell Lung Cancer
COMPLETED20 Analytics
PHASE1COMPLETED
A Study of CDX-585 in Patients With Advanced Malignancies
Non-small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Dose escalation: To determine the maximum tolerated dose of CDX-585 and to select the CDX-585 dose(s) for evaluation in tumor-specific expansion cohorts
Approximately 12 months

The rates of drug-related adverse events will be summarized, and maximum tolerated dose will be determined.

Tumor-specific expansion cohorts: To further evaluate the safety of CDX-585 by tumor type.
Approximately 6 months

The rates of drug-related adverse events will be summarized, and further evaluated in specific tumor types.

Secondary Endpoints

Safety and Tolerability of CDX-585 as assessed by CTCAE v5.0
From first dose through 90 days after last dose
Objective Response Rate
Assessed up to approximately 1-3 years.
Clinical Benefit Rate
Assessed up to approximately 1-3 years.
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CDX-585EXPERIMENTALDose-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.

Interventions

NameTypeDescription
CDX-585DRUGCDX-585 is administered by infusion every 2 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

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 ...

Countries:United States
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Frequently asked questions about CDX-585

What is CDX-585 used for?

CDX-585 is an investigational small molecule being developed for the treatment of non-small cell lung cancer. It is also being studied in other advanced solid tumors, including gastric, head and neck, ovarian, colorectal, and pancreatic cancers. The drug is currently in Phase 1 clinical development.

Who makes CDX-585?

CDX-585 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 of CDX-585 in patients with advanced malignancies.

What phase is CDX-585 in?

CDX-585 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 1 study of CDX-585 in patients with advanced malignancies has been completed.

What clinical trials is CDX-585 in?

CDX-585 has been studied in a Phase 1 clinical trial with the identifier NCT05788484, titled "A Study of CDX-585 in Patients With Advanced Malignancies." This trial enrolled 20 participants in the United States and included patients with non-small cell lung cancer and other solid tumors.

Is CDX-585 a small molecule?

Yes, CDX-585 is a small molecule therapeutic. It is being developed as an oncology treatment for non-small cell lung cancer and other advanced solid tumors. The drug is currently in Phase 1 clinical trials.