Recent Updates
Recently added Catalysts

CDX-527

Phase 1

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

CDX-527 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jun 2020

CDX-527 target and mechanism

Molecular targetPD-L1
Target classImmune Checkpoint
ModalitySmall molecule

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

CDX-527 clinical trials

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)
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria

Competitive Landscape -Non-Small Cell Lung Cancer 541 trials

Top 20 of 90 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK37PHASE3Pembrolizumab, Olaparib, Sacituzumab tirumotecan, Intismeran autogene, Pembrolizumab Berahyaluronidase alfa
Revolution Medicines, Inc.RVMD9PHASE3Daraxonrasib, Zoldonrasib, Elironrasib, RMC-5127
Eli Lilly and CompanyLLY18PHASE3Selpercatinib, Pemetrexed, Abemaciclib, Olomorasib, LY3537982
AbbVie, Inc.ABBV12PHASE3ABBV-1480, Telisotuzumab vedotin, Telisotuzumab Adizutecan, Livmoniplimab, Budigalimab
AstraZeneca PLCAZN68PHASE3Datopotamab deruxtecan, Durvalumab, Oleclumab, Monalizumab, Tremelimumab
Gilead Sciences, Inc.GILD7PHASE3Sacituzumab govitecan, Zimberelimab, Domvanalimab, Etrumadenant, TUB-040- Dose escalation
Bristol-Myers Squibb CompanyBMY24PHASE3Repotrectinib, Nivolumab, Pumitamig, Relatlimab, Adagrasib
Johnson & JohnsonJNJ19PHASE3Lazertinib, Amivantamab, JNJ-90301900, JNJ-86974680, Cetrelimab
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Pumitamig, BNT326, BNT116, BNT324
Pfizer Inc.PFE20PHASE3Lorlatinib, Crizotinib, Avelumab, Talazoparib, Axitinib
Amgen Inc.AMGN4PHASE3ABP 234, Sotorasib, Anvumetostat
Novartis AG Sponsored ADRNVS12PHASE3Opnurasib, TNO155, DKY709, Spartalizumab, trametinib
GSK plc Sponsored ADRGSK3PHASE3Dostarlimab, Belrestotug, Nelistotug, Cobolimab
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib
Summit Therapeutics IncSMMT2PHASE3Ivonescimab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Rina-S, GEN1042
Regeneron Pharmaceuticals, Inc.REGN7PHASE2Cemiplimab, Marlotamig, Fianlimab, REGN5093
Nuvalent, Inc. Class ANUVL1PHASE3Neladalkib
BeOne Medicines Ltd. Sponsored ADRONC7PHASE3Tislelizumab, BGB-A445, LBL-007, BGB-15025, BGB-43395
Unlock Competitive Intelligence

Frequently asked questions about CDX-527

What is CDX-527?

CDX-527 is an investigational bispecific antibody developed by Celldex Therapeutics for advanced solid tumors, including non-small cell lung cancer. It is designed to engage both PD-L1 and CD27, linking an immune checkpoint target with a costimulatory receptor. It has been studied in a single Phase 1 trial that is now completed.

What does CDX-527 target?

CDX-527 targets PD-L1 and CD27. PD-L1 is an immune checkpoint ligand, and CD27 is a costimulatory receptor on T cells. By binding both, the bispecific antibody is designed to block the PD-L1 checkpoint pathway while simultaneously delivering a costimulatory signal through CD27 to activate antitumor T cell responses.

Who makes CDX-527?

CDX-527 is developed by Celldex Therapeutics, Inc., a clinical-stage biopharmaceutical company that trades on the Nasdaq under the ticker CLDX. Celldex designed the agent as a PD-L1 x CD27 bispecific antibody and sponsored its clinical evaluation in patients with advanced malignancies.

What phase is CDX-527 in?

CDX-527 is in Phase 1 development and is investigational. It has not been approved by the FDA. Its only clinical trial, NCT04440943, has been completed, and no active trials of CDX-527 are currently listed. The study enrolled 27 patients with advanced solid tumors.

What clinical trials is CDX-527 in?

CDX-527 has been evaluated in one clinical trial, NCT04440943, titled A Study of the PD-L1xCD27 Bispecific Antibody CDX-527 in Patients With Advanced Malignancies. The Phase 1 trial enrolled 27 adults across sites in the United States and is completed. It was an uncontrolled study without randomization or blinding.

What is CDX-527 used for in non-small cell lung cancer?

CDX-527 was studied in non-small cell lung cancer as part of a Phase 1 trial in patients with advanced malignancies. That trial, NCT04440943, also enrolled patients with breast, gastric, renal, ovarian, bladder, esophageal, head and neck, and other solid tumors. The study is completed, and CDX-527 remains investigational.