A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused ABBV-324 in Adult Participants With Hepatocellular Cancer (HCC) or Squamous-Cell Non-Small Cell Lung Cancer (LUSC)
Condition(s) studied
Investigational drug(s) / intervention(s)
Lenvatinib: Oral Capsule
ABBV-324: Intravenous (IV) Infusion
Study summary
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.
Eligibility
Primary outcome measure(s)
- Number of Participants with Adverse Events (AE)s — Up to Approximately 4 Years
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. - Number of Participants with Change in Vital Signs — Up to Approximately 4 Years
Number of Participants with Change in Vital Signs will be assessed. - Number of Participants with Change in Electrocardiogram (ECG) — Up to Approximately 4 Years
Number of Participants with Change in ECG will be assessed. - Number of Participants with Change in Clinical Laboratory Tests — Up to Approximately 4 Years
Number of participants with change in clinical laboratory tests will be assessed. - Objective Response Rate (ORR) — Up to Approximately 4 Years
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.
Trial sites (22)
| Facility | City | Region | Status |
|---|---|---|---|
| City of Hope National Medical Center /ID# 270526 | Duarte | California | Recruiting |
| City of Hope - Orange County Lennar Foundation Cancer Center /ID# 276120 | Irvine | California | Recruiting |
| USC Norris Comprehensive Cancer Center /ID# 271573 | Los Angeles | California | Recruiting |
| University Of California Irvine Medical Center /ID# 270507 | Orange | California | Recruiting |
| UCLA - Santa Monica /ID# 275995 | Santa Monica | California | Recruiting |
| University of Chicago Medical Center /ID# 270517 | Chicago | Illinois | Recruiting |
| Washington University /ID# 275757 | St Louis | Missouri | Recruiting |
| Memorial Sloan Kettering Cancer Center /ID# 271228 | New York | New York | Recruiting |
| Thomas Jefferson University Sidney Kimmel Cancer Center /ID# 276269 | Philadelphia | Pennsylvania | Recruiting |
| SCRI Oncology Partners /ID# 272750 | Nashville | Tennessee | Recruiting |
| Nanfang Hospital - Southern Medical University /ID# 276916 | Guangzhou | Guangdong | Recruiting |
| Zhongshan Hospital Fudan University /ID# 276917 | Shanghai | Shanghai Municipality | Recruiting |
| Rabin Medical Center. /ID# 271236 | Petah Tikva | Central District | Recruiting |
| Rambam Health Care Campus /ID# 270604 | Haifa | Israel | Recruiting |
| Hadassah Medical Center-Hebrew University /ID# 271235 | Jerusalem | Israel | Recruiting |
| National Cancer Center Hospital East /ID# 270585 | Kashiwa-shi | Chiba | Recruiting |
| Kansai Medical University Hospital /ID# 272884 | Hirakata-shi | Osaka | Recruiting |
| National Cancer Center Hospital /ID# 270583 | Chuo-Ku | Tokyo | Recruiting |
| Fdi Clinical Research /ID# 272960 | San Juan | Puerto Rico | Completed |
| Hospital Universitario Fundacion Jimenez Diaz /ID# 272718 | Madrid | Spain | Recruiting |
| Hospital Universitario HM Sanchinarro /ID# 272719 | Madrid | Spain | Recruiting |
| National Taiwan University Hospital /ID# 270593 | Taipei | Taiwan | Recruiting |
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06858813 on ClinicalTrials.gov ↗ ← All trials in Spain