Hepatocellular Cancer Squamous-Cell Non-Small Cell Lung Cancer
Conditions
Interventions
Lenvatinib
ABBV-324
Sponsors
Sawa Kenji
Eligibility
Sex/Gender
All
Inclusion 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) = 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
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, nor 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events (AE)s Number of Participants with Change in Vital Signs Number of Participants with Change in Electrocardiogram (ECG) Number of Participants with Change in Clinical Laboratory Tests Objective Response Rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC of ABBV-324 Cmax of ABBV-324 Tmax of ABBV-324 t1/2 of ABBV-324 Incidence and concentration of anti-drug antibodies Incidence and concentration of neutralizing anti-drug antibodies | — |
Countries
China, Israel, Japan, Puerto Rico, Spain, United States
Contacts
Public ContactContact for Patients and HCP
AbbVie GK
Outcome results
None listed