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) (NCT06858813)
A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV 324 in Adults With Hepatocellular Cancer or Squamous Cell Non-Small Cell Lung Cancer
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: City of Hope National Medical Center /ID# 270526 — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (22 Sites)
- City of Hope National Medical Center /ID# 270526 — Duarte, California
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 276120 — Irvine, California
- USC Norris Comprehensive Cancer Center /ID# 271573 — Los Angeles, California
- UC Irvine Medical Center /ID# 270507 — Orange, California
- UCLA - Santa Monica /ID# 275995 — Santa Monica, California
- University of Chicago Medical Center /ID# 270517 — Chicago, Illinois
- Washington University /ID# 275757 — St Louis, Missouri
- Memorial Sloan Kettering Cancer Center /ID# 271228 — New York, New York
- Thomas Jefferson University Sidney Kimmel Cancer Center /ID# 276269 — Philadelphia, Pennsylvania
- SCRI Oncology Partners /ID# 272750 — Nashville, Tennessee
- Nanfang Hospital - Southern Medical University /ID# 276916 — Guangzhou, Guangdong
- Zhongshan Hospital Fudan University /ID# 276917 — Shanghai, Shanghai Municipality
- Rambam Health Care Campus /ID# 270604 — Haifa,
- Hadassah Medical Center-Hebrew University /ID# 271235 — Jerusalem,
- Rabin Medical Center. /ID# 271236 — Petah Tikva,
- National Cancer Center Hospital East /ID# 270585 — Kashiwa-shi, Chiba
- Kansai Medical University Hospital /ID# 272884 — Hirakata-shi, Osaka
- National Cancer Center Hospital /ID# 270583 — Chuo-Ku, Tokyo
- Fdi Clinical Research /ID# 272960 — San Juan,
- Hospital Universitario Fundacion Jimenez Diaz /ID# 272718 — Madrid,
- Hospital Universitario HM Sanchinarro /ID# 272719 — Madrid,
- National Taiwan University Hospital /ID# 270593 — Taipei,
📞 Contact the Study Coordinator
Phone: (844) 663-3742
Email: abbvieclinicaltrials@abbvie.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Hepatocellular Cancer
- A Longitudinal Observational Study of the Natural History and Management of Patients With HCC — Phoenix, Arizona
- Combined Treatment of Durvalumab, Bevacizumab, Tremelimumab and Transarterial Chemoembolization (TACE) in Subjects With Hepatocellular Carcinoma or Biliary Tract Carcinoma — Bethesda, Maryland
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.