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A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients with Metastatic Breast Cancer

Clinical Trial Details

This clinical trial is for women with metastatic breast cancer. There is currently a need for more effective treatment methods for this disease. 

The study drug that is being investigated in this clinical trial, SGN-LIV1A, is a type of drug called an antibody drug conjugate (ADC). This study is being done to find out what side effects are caused in patients with breast cancer who are given SGN-LIV1A (single therapy) and SGN-LIV1A in combination with trastuzumab (combination therapy). 

This study will be conducted in 3 parts: 

   - Part A (single therapy) with SGN LIV1A 
   - Part B (combination therapy) with SGN-L1V1A and trastuzumab 
   - Part C (single therapy) with a defined dose regimen of SGN LIV1A given to patients with triple negative breast cancer 

You will be given SGN-LIV1A or SGN-LIV1A in combination with trastuzumab treatment in 21-day cycles. If your cancer is stable or gets better with SGN-LIV1A or the combination therapy, you may continue to be treated in the study. 

Following the end-of-treatment tests, you will have follow-up visits and/or follow-up phone calls every 12 weeks for the first year and then every 24 weeks until the study has been completed. 

Key Eligibility: 
  • Open to women age 18 and older 
  • Diagnosed with metastatic breast cancer 
  • Detailed eligibility will be reviewed when you contact the study team

Contact

Marta Cobham, RN
mac2034@med.cornell.edu
(646) 697-0361

Primary Investigator

Eleni Andreopoulou, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

1710018678

ClinicalTrials.gov:

NCT01969643

Status:

Open to Enrollment

Age Group

Adult

Sponsor

Drug/Device

Drug

Study Type

Phase