Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer Receiving Intravenous (IV) ABBV-400
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|ClinicalTrials.gov Identifier: NCT05029882|
Recruitment Status : Not yet recruiting
First Posted : September 1, 2021
Last Update Posted : September 1, 2021
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer and is associated with poor prognosis and limited treatment options. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors.
ABBV-400 is an investigational drug being developed for the treatment of NSCLC. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) will be explored. Each treatment arm receives a different dose of ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose. Approximately 100 adult participants with NSCLC, or advanced solid tumors, will be enrolled in the study in approximately 7-10 sites in the Dose Escalation phase and 80-85 sites in the Dose Expansion phase worldwide.
In the Dose Escalation arms, participants will receive intravenous (IV) escalating doses of ABBV-400 monotherapy. In the Dose Expansion arms, participants with wtEGFR NSCLC or with mutEGFR NSCLC will receive intravenous (IV) ABBV-400 monotherapy.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: ABBV-400||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 First in Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-400 in Adult Subjects With Advanced Solid Tumors|
|Estimated Study Start Date :||September 1, 2021|
|Estimated Primary Completion Date :||June 28, 2025|
|Estimated Study Completion Date :||June 28, 2025|
Experimental: Part 1 (Monotherapy Dose Escalation)
Participants with advanced solid tumors will receive escalating doses of ABBV-400.
Intravenous (IV) Infusion
Experimental: Part 2a (wtEGFR NSCLC)
Participants with c-Met overexpressing advanced non-squamous wtEGFR NSCLC will receive ABBV-400 at the Recommended Phase 2 dose (RP2D).
Intravenous (IV) Infusion
Experimental: Part 2b (mutEGFR NSCLC)
Participants with non-squamous mutEGFR NSCLC will receive ABBV-400 at the RP2D.
Intravenous (IV) Infusion
- Change it to Objective Response Rate (ORR) [ Time Frame: Up to Month 24 ]ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Duration of Response (DOR) for Participants with Confirmed CR/PR per RECIST v1.1 [ Time Frame: Up to 24 Months ]DOR is defined for participants achieving a confirmed CR+PR as the time from the initial response of CR+PR per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier.
- PFS per RECIST v1.1 [ Time Frame: Up to 24 Months ]Progression-free survival (PFS) is defined as time from first study treatment to a documented disease progression according to RECIST version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.
- Overall survival (OS) [ Time Frame: Up to 24 Months ]Overall survival (OS) is defined as time from first study treatment to death due to 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): NCT05029882
|Contact: ABBVIE CALL CENTERemail@example.com|
|United States, Colorado|
|Univ of Colorado Cancer Center /ID# 231574|
|Aurora, Colorado, United States, 80045|
|United States, North Carolina|
|Carolina BioOncology Institute /ID# 231541|
|Huntersville, North Carolina, United States, 28078|
|United States, Virginia|
|Virginia Cancer Specialists - Fairfax /ID# 231575|
|Fairfax, Virginia, United States, 22031|
|National Cancer Center Hospital East /ID# 232008|
|Kashiwa-shi, Chiba, Japan, 277-8577|
|National Cancer Center Hospital /ID# 232007|
|Chuo-ku, Tokyo, Japan, 104-0045|
|Pan American Center for Oncology Trials, LLC /ID# 231580|
|Rio Piedras, Puerto Rico, 00935|
|Study Director:||ABBVIE INC.||AbbVie|