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CDX-527

Phase 1

Non-small Cell Lung Cancer | Small molecule | Oncology |Celldex Therapeutics, Inc.|Last Updated: Jun 18, 2023

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

CDX-527 · 1 trial · 14 indications

Phase 1 1
NCT04440943A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced MalignanciesNon-small Cell Lung Cancer
COMPLETED27 Analytics
PHASE1COMPLETED
A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies
Non-small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Tolerability of CDX-527 as assessed by CTCAE v5.0
From first dose through 28 days after last dose

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

Secondary Endpoints

Objective Response Rate
Every 8 weeks starting with first dose until disease progression, assessed up to approximately 1-2 years.
Clinical Benefit Rate
Every 8 weeks, starting with first dose until disease progression, assessed up to approximately 1-2 years.
Duration of Response
First occurrence of a documented objective response to disease progression or death (up to approximately 1-2 years)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CDX-527EXPERIMENTALDose-escalation phase: Eligible patients will receive CDX-527 treatment based on cohort assigned until progression or intolerance. Expansion phase: Patients will receive CDX-527 at the dose level(s) chosen during the escalation phase.

Interventions

NameTypeDescription
CDX-527DRUGCDX-527 is administered by infusion every 2 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Key Inclusion Criteria: 1. Recurrent, locally advanced or metastatic solid tumor cancer excluding the following: MSI-low colorectal cancer, glioblastoma multiforme, prostate cancer, pancreatic cancer, mucosal and ocular melanoma. 2. Receipt of all standard therapies for the tumor type 3. Measurable...

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

Frequently asked questions about CDX-527

What is CDX-527 used for?

CDX-527 is an investigational bispecific antibody being studied for the treatment of non-small cell lung cancer and other advanced solid tumors. It targets PD-L1 and CD27 to potentially enhance the immune response against cancer cells. The drug is currently in Phase 1 clinical development.

What does CDX-527 target?

CDX-527 targets PD-L1 and CD27. PD-L1 is an immune checkpoint protein that tumors use to evade immune detection, while CD27 is a costimulatory receptor on T cells. By engaging both targets, CDX-527 aims to activate T cells while blocking the PD-L1 pathway.

Who makes CDX-527?

CDX-527 is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol CLDX. The company is conducting clinical trials to evaluate the safety and efficacy of this bispecific antibody in patients with advanced malignancies.

What phase is CDX-527 in?

CDX-527 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under investigation for potential therapeutic use.

What clinical trials is CDX-527 in?

CDX-527 has been studied in one clinical trial with the identifier NCT04440943. This Phase 1 study, titled 'A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies,' enrolled 27 participants with various solid tumors, including non-small cell lung cancer. The trial was conducted in the United States and has been completed.

Is CDX-527 the same as a PD-L1xCD27 bispecific antibody?

Yes, CDX-527 is a PD-L1xCD27 bispecific antibody. It is designed to simultaneously bind to PD-L1 and CD27. This dual targeting approach is intended to modulate the immune system's response to tumors, potentially offering a novel treatment option for patients with advanced cancers.