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New treatment option for Hepatocellular Cancer
Official title 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)
ClinicalTrials.gov ID: NCT06858813
What this study is testing
What is Lenvatinib?
Lenvatinib is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatocellular cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Measurable disease per RECIST version 1.1.
You likely can't join if
- 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...
- History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or...
- 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...
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Irvine, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Santa Monica, California, United States
- Chicago, Illinois, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Guangzhou, Guangdong, China
- Shanghai, Shanghai Municipality, China
- Haifa, Israel
- Jerusalem, Israel
- Petah Tikva, Israel
- Kashiwa-shi, Chiba, Japan
- Hirakata-shi, Osaka, Japan
- Chuo-Ku, Tokyo, Japan
- San Juan, Puerto Rico
- Madrid, Spain
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Irvine, California, United States; Los Angeles, California, United States; Orange, California, United States; Santa Monica, California, United States; Chicago, Illinois, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.