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CDX1307

Phase 1

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

CDX1307 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2008

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment84

FDA Designations

No designations recorded

CDX1307 clinical trials

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 609 trials

Frequently asked questions about CDX1307

What is CDX1307?

CDX1307 is an investigational monoclonal antibody developed by Celldex Therapeutics, Inc. for the treatment of cancer. It was studied in Phase 1 clinical trials in patients with incurable solid tumors, including breast cancer, colorectal cancer, pancreatic cancer, ovarian cancer, and bladder cancer. It is not an approved therapy.

What is CDX1307 used for in breast cancer?

CDX1307 was studied in Phase 1 trials as a treatment for incurable breast cancer, along with colorectal, pancreatic, ovarian, and bladder cancers. The trials enrolled patients with locally advanced or metastatic disease. It remains an investigational agent and is not approved for breast cancer or any other indication.

Who makes CDX1307?

CDX1307 was developed by Celldex Therapeutics, Inc., a biopharmaceutical company that trades under the ticker CLDX. Celldex sponsored the Phase 1 clinical program evaluating the antibody in patients with advanced solid tumors, including breast cancer.

What phase is CDX1307 in?

CDX1307 is in Phase 1. Two Phase 1 trials were conducted, and both are now completed. No active trials are ongoing. The studies together enrolled 84 patients and evaluated CDX1307 in incurable breast, colorectal, pancreatic, ovarian, and bladder cancers.

What clinical trials was CDX1307 studied in?

CDX1307 was evaluated in two completed Phase 1 trials: NCT00709462, which enrolled 48 patients with incurable breast, colorectal, pancreatic, ovarian, or bladder cancer, and NCT00648102, which enrolled 36 patients with locally advanced or metastatic forms of those cancers. Both were conducted in the United States.

Is CDX1307 the same as CDX-1307?

Yes. CDX1307 and CDX-1307 refer to the same investigational monoclonal antibody from Celldex Therapeutics. The hyphenated spelling appears in the trial titles and registry listings, while the unhyphenated form is also used. Both names describe the same Phase 1 cancer asset.