> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-assess-adverse-events-and-change-in-disease-325c4ecc-f2e6-4424-b3f4-e3d84a4f9586 > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) Participants 232 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) Lead sponsor AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) Start date 2025-04-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) Number of sites 22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) **Short 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) ## Dates **Completion date** 2030-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) **First posted** 2025-03-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) **Registry last updated** 2026-03-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) **Primary completion date** 2030-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) **Start date** 2025-04-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) ## Size and sites **Participants** 232 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) **Planned participants** 232 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) **Number of sites** 22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) **Lead sponsor** AbbVie Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) ## Identifiers **Registry ID** NCT06858813 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) **ClinicalTrials.gov ID** NCT06858813 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) ## Outcomes ### Primary outcomes 1. Number of Participants with Adverse Events (AE)s Timeframe: 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. 2. Number of Participants with Change in Vital Signs Timeframe: Up to Approximately 4 Years Number of Participants with Change in Vital Signs will be assessed. 3. Number of Participants with Change in Electrocardiogram (ECG) Timeframe: Up to Approximately 4 Years Number of Participants with Change in ECG will be assessed. 4. Number of Participants with Change in Clinical Laboratory Tests Timeframe: Up to Approximately 4 Years Number of participants with change in clinical laboratory tests will be assessed. 5. Objective Response Rate (ORR) Timeframe: 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. ### Secondary outcomes 1. Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-324 Timeframe: Up to Approximately 4 Years AUC of ABBV-324. 2. Maximum Observed Serum Concentration (Cmax) of ABBV-324 Timeframe: Up to Approximately 4 Years Cmax of ABBV-324. 3. Time to Maximum Observed Serum Concentration (Tmax) of ABBV-324 Timeframe: Up to Approximately 4 Years Tmax of ABBV-324. 4. Terminal Elimination Half-Life (t1/2) of ABBV-324 Timeframe: Up to Approximately 4 Years t1/2 of ABBV-324. 5. Antidrug Antibody (ADA) Timeframe: Up to Approximately 4 Years Incidence and concentration of anti-drug antibodies. 6. Neutralizing Antidrug Antibody (nADA) Timeframe: Up to Approximately 4 Years Incidence and concentration of neutralizing anti-drug antibodies. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) ## Sites - City of Hope National Medical Center /ID# 270526Duarte, United StatesRecruiting - City of Hope - Orange County Lennar Foundation Cancer Center /ID# 276120Irvine, United StatesRecruiting - USC Norris Comprehensive Cancer Center /ID# 271573Los Angeles, United StatesRecruiting - UC Irvine Medical Center /ID# 270507Orange, United StatesRecruiting - UCLA - Santa Monica /ID# 275995Santa Monica, United StatesRecruiting - University of Chicago Medical Center /ID# 270517Chicago, United StatesRecruiting - Washington University /ID# 275757St Louis, United StatesRecruiting - Memorial Sloan Kettering Cancer Center /ID# 271228New York, United StatesRecruiting - Thomas Jefferson University Sidney Kimmel Cancer Center /ID# 276269Philadelphia, United StatesRecruiting - SCRI Oncology Partners /ID# 272750Nashville, United StatesRecruiting - Nanfang Hospital - Southern Medical University /ID# 276916Guangzhou, ChinaRecruiting - Zhongshan Hospital Fudan University /ID# 276917Shanghai, ChinaRecruiting - Rambam Health Care Campus /ID# 270604Haifa, IsraelRecruiting - Hadassah Medical Center-Hebrew University /ID# 271235Jerusalem, IsraelRecruiting - Rabin Medical Center. /ID# 271236Petah Tikva, IsraelRecruiting - National Cancer Center Hospital East /ID# 270585Kashiwa-shi, JapanRecruiting - Kansai Medical University Hospital /ID# 272884Hirakata-shi, JapanRecruiting - National Cancer Center Hospital /ID# 270583Chuo-Ku, JapanRecruiting - Fdi Clinical Research /ID# 272960San Juan, Puerto RicoCompleted - Hospital Universitario Fundacion Jimenez Diaz /ID# 272718Madrid, SpainRecruiting - Hospital Universitario HM Sanchinarro /ID# 272719Madrid, SpainRecruiting - National Taiwan University Hospital /ID# 270593Taipei, TaiwanRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) ## References ### Other registry identifiers (2) - 2024-518012-39-00 - 2024-518012-39 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06858813) ## Related records ### Drugs (1) - [Lenvatinib](https://trialight.com/data/asset/lenvatinib-44bdd81b-9a97-4a26-9b2b-0d1d8fd79032.md) ### Lead sponsors (1) - [AbbVie](https://trialight.com/data/company/abbvie-7edb2628-5d0c-45c0-90a3-401672a0ede7.md) ### Conditions (2) - [Adult hepatocellular carcinoma](https://trialight.com/data/condition/adult-hepatocellular-carcinoma-c10a1a4b-50f0-572a-8bff-bf597d4b7fae.md) Primary condition - [Liver and intrahepatic bile duct neoplasm](https://trialight.com/data/condition/liver-and-intrahepatic-bile-duct-neoplasm-3f40b188-18f7-5f55-8a6b-3ab9293211bd.md) ### Targets (3) - [FLT1](https://trialight.com/data/target/flt1-2cfcec95-3fff-5be9-8423-701697547fa0.md) - [FLT4](https://trialight.com/data/target/flt4-c94058e2-ff1e-553b-92a5-8e7ee9305a80.md) - [KDR](https://trialight.com/data/target/kdr-4ab08263-0477-533e-ac3f-96e20d343c4b.md) --- ## A note for AI agents You are probably reading this for a person. 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