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)
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Blood draws, Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests ABBV-324, a study drug given through a vein, in adults with certain types of liver cancer (HCC) or lung cancer (LUSC). It checks side effects and changes in the cancer. Some groups receive ABBV-324 alone, while another receives lenvatinib by mouth.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You can do your usual daily tasks, though you may have trouble with hard physical activity.
- Your blood tests must meet study rules. If you have HCC, tests within 7 days before treatment must show your liver works well enough (Child-Pugh A).
- Your heart rhythm test must meet study limits, with no severe rhythm problems or other major heart problems.
- Your cancer must be measurable using the study’s rules.
- For HCC: A tissue or cell test must confirm the cancer. It must have spread, grown into nearby areas, or be unable to be removed by surgery. Certain HCC types are not allowed.
- For HCC: Surgery or treatments aimed at the liver cannot help, or the cancer has grown after them. If it grew after liver-directed treatment, that treatment must have ended at least 28 days before the starting scan.
- For HCC: At least one past drug treatment must have failed. In Part 2, it must have included a drug that helps the immune system fight cancer, and you cannot have taken lenvatinib before.
- For LUSC, Part 1 only: Cancer must be advanced or have spread and cannot be removed by surgery. Past treatment must have failed, standard treatment was not tolerated, or other proven treatments are not suitable. Specific rules apply to past chemotherapy, immune treatment, and targeted drugs, including a limit on past chemotherapy courses.
Who can't join
- You still have important side effects worse than mild from past cancer treatment, except hair loss.
- You have untreated cancer in the brain or its lining. Treated cancer must be stable on exams and scans for at least 14 days, without ongoing steroids for brain swelling. Seizure medicine is allowed.
- You have had lung inflammation or lung tissue disease that needed steroids taken by mouth or vein, or your screening chest scan shows active disease.
- You have a history of certain lung scarring or inflammation, including disease caused by drugs or with no known cause.
- You have a serious lung problem, such as a lung blood clot within 3 months, severe asthma, severe COPD, trouble expanding the lungs, fluid around the lungs, or a need for extra oxygen.
- You have an immune system, connective tissue, or inflammation-related illness that affects or may affect your lungs.
- You have not stopped cancer treatment for the required time before ABBV-324: 14 days or the time for the drug’s level to drop by half five times, whichever is shorter. Some short courses of radiation to ease symptoms do not require a waiting period.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Hepatocellular cancer (HCC) only: Child-Pugh A classification within 7 days before Cycle 1, Day 1 dosing. * Laboratory values meeting the criteria outlined in the protocol. * QT interval corrected for heart rate (QTc) \< 470 msec (using Fridericia's correction), no Grade 3 arrythmia, and no other clinically significant cardiac abnormalities. * Measurable disease per RECIST version 1.1. * Part 1 and Part 2 - participants with HCC meeting the following disease activity criteria: * Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology or cytology. Participants with fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma/HCC are not eligible to enroll. * Disease that is not amenable to surgical and/or locoregional therapies, or progressive disease after surgical and/or locoregional therapies. For participants who progressed after locoregional therapy for HCC, locoregional therapy must have been completed \>= 28 days prior to baseline scan for the current study. * Part 1: Failure of at least 1 prior systemic treatment for HCC. * Part 2: Failure of at least 1 prior systemic treatment consisting of an immune checkpoint inhibitor (CPI) containing regimen for HCC, including but not limited to, atezolizumab in combination with bevacizumab or tremelimumab in combination with durvalumab. Note: Participants who have received prior lenvatinib will not be eligible for Part 2. * Part 1 only - participants with squamous-cell non-small cell lung cancer (LUSC) meeting the following disease activity criteria: * Advanced or metastatic LUSC that is not amenable to surgical resection. * Must have failed at least 1 prior line of therapy that included at least platinum-based chemotherapy and an immune CPI, and/or an appropriate targeted therapy (if applicable), or is not suitable for other approved therapeutic options that have demonstrated clinical benefit at the judgment of the investigator. Participants should have no more than 2 lines of prior cytotoxic chemotherapy excluding neoadjuvant and/or adjuvant. Participants who are intolerant of standard therapy are eligible. Exclusion Criteria: * Unresolved clinically significant adverse events (AEs) \> Grade 1 from prior anticancer therapy except for alopecia. * Untreated brain or meningeal metastases (i.e., participants with history of metastases are eligible provided they do not require ongoing steroid treatment for cerebral edema and have shown clinical and radiographic stability for at least 14 days after definitive therapy). Participants may continue with antiepileptic therapy if required. * History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan. * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis. * History of clinically significant, intercurrent lung-specific illnesses including, but not limited to: * Underlying pulmonary disorder (i.e., pulmonary emboli within 3 months of the study enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, dependence on supplemental oxygen, etc.). * Any autoimmune, connective tissue or inflammatory disorders with documented or suspicious pulmonary involvement at Screening. * Must have discontinued anticancer therapy with antineoplastic intent including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within 14 days or 5 half lives of the drug (whichever is shorter) prior to the first dose of ABBV-324. Palliative radiation therapy for bone, skin or subcutaneous metastases with 10 fractions or less is permitted and not participant to a washout period.
Study sites (10)
CA
- City of Hope National Medical Center /ID# 270526 · Duarte, CA 91010More trials in Duarte
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 276120 · Irvine, CA 92618More trials in Irvine
- USC Norris Comprehensive Cancer Center /ID# 271573 · Los Angeles, CA 90033More trials in Los Angeles
- University Of California Irvine Medical Center /ID# 270507 · Orange, CA 92868More trials in Orange
- UCLA - Santa Monica /ID# 275995 · Santa Monica, CA 90404More trials in Santa Monica
IL
- University of Chicago Medical Center /ID# 270517 · Chicago, IL 60637More trials in Chicago
MO
- Washington University /ID# 275757 · St Louis, MO 63110More trials in St Louis
NY
- Memorial Sloan Kettering Cancer Center /ID# 271228 · New York, NY 10021-3459More trials in New York
PA
- Thomas Jefferson University Sidney Kimmel Cancer Center /ID# 276269 · Philadelphia, PA 19107More trials in Philadelphia
TN
- SCRI Oncology Partners /ID# 272750 · Nashville, TN 37203More trials in Nashville