An Efficacy and Safety Study of Cofetuzumab Pelidotin in Participants With PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT04189614|
Recruitment Status : Recruiting
First Posted : December 6, 2019
Last Update Posted : September 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cancer Non-small Cell Lung Cancer (NSCLC)||Drug: Cofetuzumab Pelidotin||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1b Efficacy and Safety Study of Cofetuzumab Pelidotin (ABBV-647, a PTK7-Targeting Antibody Drug Conjugate) in Subjects With PTK7-Expressing, Recurrent Non-Small Cell Lung Cancer|
|Actual Study Start Date :||February 13, 2020|
|Estimated Primary Completion Date :||October 10, 2022|
|Estimated Study Completion Date :||August 16, 2023|
Experimental: Cofetuzumab Pelidotin
Participants will receive 2.8mg/kg of cofetuzumab pelidotin by IV every 3 weeks
Drug: Cofetuzumab Pelidotin
Intravenous (IV) infusion
Other Name: ABBV-647
- Objective Response Rate (ORR) [ Time Frame: Up to approximately 3 years ]ORR assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria and defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR).
- Duration of Response (DOR) [ Time Frame: Up to approximately 3 years ]DOR is defined as the time from the participant's initial response (CR or PR) to the first occurrence of radiographic progression or death from any cause.
- Progression Free Survival (PFS) [ Time Frame: Up to approximately 3 years ]PFS is defined as the time from the participant's first dose of study drug until radiographic progression or death from any cause.
- Overall Survival (OS) [ Time Frame: Up to approximately 3 years ]OS is defined as the time from the participant's first dose of study drug until death from any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04189614
|Contact: ABBVIE CALL CENTERfirstname.lastname@example.org|
|Study Director:||ABBVIE INC.||AbbVie|