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)

Part of paid clinical trials in Duarte, California.

Sponsor
AbbVie
Study ID
NCT06858813
Phase
PHASE1
Status
Recruiting
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Conditions

  • Hepatocellular Cancer
  • Squamous-Cell Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lenvatinib — DRUG
    Oral Capsule
  • ABBV-324 — DRUG
    Intravenous (IV) Infusion

Study Details

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.

Key Dates

Start date
Apr 14, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
232 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 Dose Escalation: ABBV-324
    Participants will receive escalating doses of ABBV-324 as part of the approximately 6.5 year study duration.
  • Experimental: Part 2 Dose Optimization Arm 1: ABBV-324 Dose 1
    Participants will receive ABBV-324 dose 1 as part of the approximately 6.5 year study duration.
  • Experimental: Part 2 Dose Optimization Arm 1: ABBV-324 Dose 2
    Participants will receive ABBV-324 dose 2 as part of the approximately 6.5 year study duration.
  • Experimental: Part 2 Dose Optimization Arm 1: ABBV-324 Dose 3
    Participants will receive ABBV-324 dose 3 as part of the approximately 6.5 year study duration.
  • Active Comparator: Part 2 Comparator Arm 4: Lenvatinib
    Participants will receive lenvatinib as part of the approximately 6.5 year study duration.

Primary Outcome Measure

Number of Participants with Adverse Events (AE)s [ Time Frame: Up to Approximately 4 Years ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
City of Hope National Medical Center /ID# 270526DuarteCalifornia91010-
City of Hope - Orange County Lennar Foundation Cancer Center /ID# 276120IrvineCalifornia92618-
USC Norris Comprehensive Cancer Center /ID# 271573Los AngelesCalifornia90033-
UC Irvine Medical Center /ID# 270507OrangeCalifornia92868-3201-
UCLA - Santa Monica /ID# 275995Santa MonicaCalifornia90404-
University of Chicago Medical Center /ID# 270517ChicagoIllinois60637-
Washington University /ID# 275757St LouisMissouri63110-
Memorial Sloan Kettering Cancer Center /ID# 271228New YorkNew York10021-3459-
Thomas Jefferson University Sidney Kimmel Cancer Center /ID# 276269PhiladelphiaPennsylvania19107-
SCRI Oncology Partners /ID# 272750NashvilleTennessee37203-

Find similar trials in Duarte, CA

By research site
City of Hope National Medical Center· Duarte, CACity of Hope - Orange County Lennar Foundation Cancer Center· Irvine, CAUSC Norris Comprehensive Cancer Center· Los Angeles, CAUC Irvine Medical Center· Orange, CAUCLA - Santa Monica· Santa Monica, CAUniversity of Chicago Medical Center· Chicago, IL

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