OncoMatch/Clinical Trials/NCT06858813
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)
Is NCT06858813 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Lenvatinib and ABBV-324 for hepatocellular cancer.
Treatment: Lenvatinib · ABBV-324 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Non-Small Cell Lung Carcinoma
Disease stage
Required: Stage III, IV
Measurable disease per RECIST version 1.1. Locally advanced or metastatic and/or unresectable HCC... Advanced or metastatic LUSC that is not amenable to surgical resection.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic treatment — HCC, Part 1
Part 1: Failure of at least 1 prior systemic treatment for HCC.
Must have received: immune checkpoint inhibitor containing regimen (atezolizumab in combination with bevacizumab, tremelimumab in combination with durvalumab) — HCC, Part 2
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.
Must have received: platinum-based chemotherapy — LUSC, Part 1
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.
Must have received: immune checkpoint inhibitor — LUSC, Part 1
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.
Cannot have received: lenvatinib (lenvatinib)
Participants who have received prior lenvatinib will not be eligible for Part 2.
Lab requirements
Liver function
Hepatocellular cancer (HCC) only: Child-Pugh A classification within 7 days before Cycle 1, Day 1 dosing.
Cardiac function
QTc < 470 msec (using Fridericia's correction), no Grade 3 arrythmia, and no other clinically significant cardiac abnormalities.
Hepatocellular cancer (HCC) only: Child-Pugh A classification within 7 days before Cycle 1, Day 1 dosing. QT interval corrected for heart rate (QTc) < 470 msec (using Fridericia's correction), no Grade 3 arrythmia, and no other clinically significant cardiac abnormalities. Laboratory values meeting the criteria outlined in the protocol.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
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