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Expanded Access to Telisotuzumab Vedotin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04830202
Expanded Access Status : Available
First Posted : April 5, 2021
Last Update Posted : January 6, 2023
Information provided by (Responsible Party):

Tracking Information
First Submitted Date March 31, 2021
First Posted Date April 5, 2021
Last Update Posted Date January 6, 2023
Descriptive Information
Brief Title Expanded Access to Telisotuzumab Vedotin
Official Title Expanded Access to Telisotuzumab Vedotin
Brief Summary This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Telisotuzumab vedotin prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.
Detailed Description Not Provided
Study Type Expanded Access
Expanded Access Type Individual Patients
Condition Non-Small Cell Lung Cancer (NSCLC)
Intervention Drug: Telisotuzumab vedotin
Intravenous Infusion
Other Name: ABBV-399
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Expanded Access Status Available
Eligibility Criteria

Inclusion Criteria:

- The participant must not be eligible for a telisotuzumab vedotin clinical trial.

Sex/Gender Not Provided
Ages 18 Years and older   (Adult, Older Adult)
Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com
Listed Location Countries Not Provided
Removed Location Countries Australia,   Hong Kong,   Israel
Administrative Information
NCT Number NCT04830202
Other Study ID Numbers C20-503
Current Responsible Party AbbVie
Original Responsible Party Same as current
Current Study Sponsor AbbVie
Original Study Sponsor Same as current
Collaborators Not Provided
Study Director: ABBVIE INC. AbbVie
PRS Account AbbVie
Verification Date February 2022