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CDX1307

Phase 1

Breast Cancer | Monoclonal antibody | Oncology |Celldex Therapeutics, Inc.|Last Updated: Jul 26, 2010

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment84

FDA Designations

No designations recorded

Clinical trial landscape

CDX1307 · 2 trials · 5 indications

Phase 1 2
NCT00648102Phase I Study of CDX-1307, hCG-B Vaccine, for Patients With Incurable, Locally Advanced or Metastatic Breast, Colorectal, Pancreatic, Bladder or Ovarian CancerBreast Cancer
COMPLETED36 Analytics
NCT00709462A Study of CDX-1307, in Patients With Incurable Breast, Colorectal, Pancreatic, Ovarian or Bladder Cancer (CDX 1307-01)Breast Cancer
COMPLETED48 Analytics
PHASE1COMPLETED
Phase I Study of CDX-1307, hCG-B Vaccine, for Patients With Incurable, Locally Advanced or Metastatic Breast, Colorectal, Pancreatic, Bladder or Ovarian Cancer
Breast CancerUnlock trial analytics
PHASE1COMPLETED
A Study of CDX-1307, in Patients With Incurable Breast, Colorectal, Pancreatic, Ovarian or Bladder Cancer (CDX 1307-01)
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

To establish safety and tolerability profile of CDX1307 alone and with adjuvant in patients with breast, colorectal, pancreatic, bladder and ovarian cancer
up to 2 years or until progression
To establish the safety and tolerability profile of CDX-1307 in patients with incurable breast, colorectal, pancreatic, ovarian or bladder cancer, alone and in combination with adjuvants.
up to 2 years or until progression

Secondary Endpoints

Investigate clinical activity
up to 2 years or until progression
To evaluate dose-limiting toxicities, immune response, and clinical activity (tumor response and time to progression)
up to 2 years or until progression
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
CDX-1307BIOLOGICAL -
CDX1307BIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria 1. Patients must have incurable, metastatic or unresectable locally advanced breast, colorectal, pancreatic, bladder or ovarian cancer with measurable or evaluable-only disease. Locally advanced breast cancer is defined as inflammatory breast cancer with biopsy-proven skin involv...

Countries:United States
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Competitive Landscape -Breast Cancer 402 trials

Top 20 of 92 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN47PHASE3Fulvestrant, Capivasertib
Merck & Co., Inc.MRK12PHASE3Pembrolizumab, Paclitaxel, Doxorubicin, Epirubicin, Cyclophosphamide
Eli Lilly and CompanyLLY27PHASE3Abemaciclib, Standard Adjuvant Endocrine Therapy
BioNTech SE Sponsored ADRBNTX7PHASE3DB-1303/BNT323, T-DM1
Gilead Sciences, Inc.GILD13PHASE3Sacituzumab Govitecan-hziy, Eribulin, Capecitabine Product, Gemcitabine, Vinorelbine
Novartis AG Sponsored ADRNVS30PHASE3Ribociclib
Pfizer Inc.PFE34PHASE3ARV-471, Fulvestrant
BeOne Medicines Ltd. Sponsored ADRONC5PHASE3BGB-43395, Letrozole, Abemaciclib, Palbociclib, Ribociclib
Olema Pharmaceuticals, Inc.OLMA5PHASE3Palazestrant, Fulvestrant, Anastrozole, Letrozole, Exemestane
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Trastuzumab, Eribulin, Vinorelbine, Gemcitabine
Celcuity Inc.CELC3PHASE3Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Relay Therapeutics, Inc.RLAY2PHASE3Zovegalisib, Capivasertib, Fulvestrant
GSK plc Sponsored ADRGSK2PHASE3Niraparib
Greenwich LifeSciences, Inc.GLSI1PHASE3GLSI-100
Bristol-Myers Squibb CompanyBMY5PHASE2Iza-bren, Nab-paclitaxel, Paclitaxel, Capecitabine, Carboplatin
BriaCell Therapeutics CorpBCTX2PHASE3SV-BR-1-GM, Cyclophosphamide, Interferon infiltration of the inoculation site, Retifanlimab, Treatment of Physician's Choice
Incyte CorporationINCY4PHASE2Ruxolitinib, Capecitabine, Regorafenib
Natera, Inc.NTRA3PHASE2Discontinuation of the anti-HER2 maintenance therapy
Puma Biotechnology, Inc.PBYI3PHASE2Neratinib, Loperamide, Colesevelam
Atossa Therapeutics, Inc.ATOS1PHASE2endoxifen, goserelin
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Frequently asked questions about CDX1307

What is CDX1307 used for?

CDX1307 is an investigational monoclonal antibody being studied for the treatment of breast cancer, as well as colorectal, pancreatic, bladder, and ovarian cancers. It is being developed by Celldex Therapeutics, Inc. (CLDX) and is currently in Phase 1 clinical development.

Who makes CDX1307?

CDX1307 is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company traded under the ticker symbol CLDX. The drug is an investigational monoclonal antibody in Phase 1 clinical development for the treatment of breast cancer and other solid tumors.

What phase is CDX1307 in?

CDX1307 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. Two Phase 1 trials have been completed, with a total enrollment of 84 patients.

What clinical trials is CDX1307 in?

CDX1307 has been studied in two completed Phase 1 clinical trials: NCT00648102, which enrolled 36 patients, and NCT00709462, which enrolled 48 patients. Both trials included patients with breast, colorectal, pancreatic, bladder, or ovarian cancer and were conducted in the United States.

Is CDX1307 the same as a vaccine?

CDX1307 is described as a monoclonal antibody, but one of its clinical trials, NCT00648102, refers to it as a 'hCG-B Vaccine.' This suggests the drug may have vaccine-like properties, though it is classified as a monoclonal antibody in development for cancer treatment.