HCC is a common cancer worldwide and a leading cause of cancer-related death. Lung cancer is the most frequently diagnosed cancer in the world, and the leading cause of cancer deaths. The purpose of this study is to assess adverse events and change in disease activity when ABBV-324 is given to adult participants to treat hepatocellular cancer (HCC) or squamous-cell non-small cell lung cancer (LUSC). ABBV-324 is an investigational drug being developed for the treatment of HCC and LUSC. Study doctors put the participants in groups called arms. Each arm receives ABBV-324 alone (monotherapy) or a comparator drug, lenvatinib followed by a safety follow-up period. Approximately 232 HCC or LUSC will be enrolled in the study in approximately 45 sites worldwide. In the dose escalation stage participants will be treated with increasing intravenous (IV) doses of ABBV-324 until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will receive ABBV-324, or a comparator of oral lenvatinib. The study will run for a duration of approximately 6.5 years. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
232
Oral Capsule
Intravenous (IV) Infusion
City of Hope National Medical Center /ID# 270526
Duarte, California, United States
RECRUITINGCity of Hope - Orange County Lennar Foundation Cancer Center /ID# 276120
Irvine, California, United States
RECRUITINGUSC Norris Comprehensive Cancer Center /ID# 271573
Los Angeles, California, United States
RECRUITINGUC Irvine Medical Center /ID# 270507
Orange, California, United States
RECRUITINGUCLA - Santa Monica /ID# 275995
Santa Monica, California, United States
RECRUITINGUniversity of Chicago Medical Center /ID# 270517
Chicago, Illinois, United States
RECRUITINGWashington University /ID# 275757
St Louis, Missouri, United States
RECRUITINGMemorial Sloan Kettering Cancer Center /ID# 271228
New York, New York, United States
RECRUITINGThomas Jefferson University Sidney Kimmel Cancer Center /ID# 276269
Philadelphia, Pennsylvania, United States
RECRUITINGSCRI Oncology Partners /ID# 272750
Nashville, Tennessee, United States
RECRUITING...and 11 more locations
Number of Participants with Adverse Events (AE)s
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to Approximately 4 Years
Number of Participants with Change in Vital Signs
Number of Participants with Change in Vital Signs will be assessed.
Time frame: Up to Approximately 4 Years
Number of Participants with Change in Electrocardiogram (ECG)
Number of Participants with Change in ECG will be assessed.
Time frame: Up to Approximately 4 Years
Number of Participants with Change in Clinical Laboratory Tests
Number of participants with change in clinical laboratory tests will be assessed.
Time frame: Up to Approximately 4 Years
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with a confirmed Complete Response or partial response(PR) per investigator review according to response evaluation criteria in solid tumors (RECIST) version 1.1.
Time frame: Up to Approximately 4 Years
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-324
AUC of ABBV-324.
Time frame: Up to Approximately 4 Years
Maximum Observed Serum Concentration (Cmax) of ABBV-324
Cmax of ABBV-324.
Time frame: Up to Approximately 4 Years
Time to Maximum Observed Serum Concentration (Tmax) of ABBV-324
Tmax of ABBV-324.
Time frame: Up to Approximately 4 Years
Terminal Elimination Half-Life (t1/2) of ABBV-324
t1/2 of ABBV-324.
Time frame: Up to Approximately 4 Years
Antidrug Antibody (ADA)
Incidence and concentration of anti-drug antibodies.
Time frame: Up to Approximately 4 Years
Neutralizing Antidrug Antibody (nADA)
Incidence and concentration of neutralizing anti-drug antibodies.
Time frame: Up to Approximately 4 Years
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