이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

간세포 암 (HCC) 또는 편평 세포 비소 세포 폐암 (LUSC)을 가진 성인 참가자에서 정맥 내 주입 ABBV-324의 부작용 및 질병 활동의 부작용 및 변화를 평가하는 연구.

2026년 9월 18일 업데이트: AbbVie

간세포 암 또는 편평 세포가 아닌 세포 세포 폐암 성인에서 ABBV 324의 안전성, 약동학 및 효능을 평가하는 1 상 1 차 인간 연구

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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

232

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 대만
      • Taipei, 대만, 100
        • 모병
        • National Taiwan University Hospital /ID# 270593
  • 미국
    • California
      • Duarte, California, 미국, 91010
        • 모병
        • City of Hope National Medical Center /ID# 270526
      • Irvine, California, 미국, 92618
        • 모병
        • City of Hope - Orange County Lennar Foundation Cancer Center /ID# 276120
      • Los Angeles, California, 미국, 90033
        • 모병
        • USC Norris Comprehensive Cancer Center /ID# 271573
      • Orange, California, 미국, 92868
        • 모병
        • University Of California Irvine Medical Center /ID# 270507
      • Santa Monica, California, 미국, 90404
        • 모병
        • UCLA - Santa Monica /ID# 275995
    • Illinois
      • Chicago, Illinois, 미국, 60637
        • 모병
        • University of Chicago Medical Center /ID# 270517
    • Missouri
      • St Louis, Missouri, 미국, 63110
        • 모병
        • Washington University /ID# 275757
    • New York
      • New York, New York, 미국, 10021-3459
        • 모병
        • Memorial Sloan Kettering Cancer Center /ID# 271228
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19107
        • 모병
        • Thomas Jefferson University Sidney Kimmel Cancer Center /ID# 276269
    • Tennessee
      • Nashville, Tennessee, 미국, 37203
        • 모병
        • SCRI Oncology Partners /ID# 272750
  • 스페인
      • Madrid, 스페인, 28040
        • 모병
        • Hospital Universitario Fundacion Jimenez Diaz /ID# 272718
      • Madrid, 스페인, 28050
        • 모병
        • Hospital Universitario HM Sanchinarro /ID# 272719
  • 이스라엘
      • Haifa, 이스라엘, 3109601
        • 모병
        • Rambam Health Care Campus /ID# 270604
      • Jerusalem, 이스라엘, 91120
        • 모병
        • Hadassah Medical Center-Hebrew University /ID# 271235
    • Central District
      • Petah Tikva, Central District, 이스라엘, 4941492
        • 모병
        • Rabin Medical Center. /ID# 271236
  • 일본
    • Chiba
      • Kashiwa-shi, Chiba, 일본, 277-8577
        • 모병
        • National Cancer Center Hospital East /ID# 270585
    • Osaka
      • Hirakata-shi, Osaka, 일본, 573-1191
        • 모병
        • Kansai Medical University Hospital /ID# 272884
    • Tokyo
      • Chuo-Ku, Tokyo, 일본, 104-0045
        • 모병
        • National Cancer Center Hospital /ID# 270583
  • 중국
    • Guangdong
      • Guangzhou, Guangdong, 중국, 510000
        • 모병
        • Nanfang Hospital - Southern Medical University /ID# 276916
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, 중국, 200032
        • 모병
        • Zhongshan Hospital Fudan University /ID# 276917
  • 푸에르토 리코
      • San Juan, 푸에르토 리코, 00927
        • 완전한
        • Fdi Clinical Research /ID# 272960

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Part 1 Dose Escalation: ABBV-324

Participants will receive escalating doses of ABBV-324 as part of the approximately 6.5 year study duration.
의약품: ABBV-324

Intravenous (IV) Infusion
실험적: 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.
의약품: ABBV-324

Intravenous (IV) Infusion
실험적: 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.
의약품: ABBV-324

Intravenous (IV) Infusion
실험적: 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.
의약품: ABBV-324

Intravenous (IV) Infusion
활성 비교기: Part 2 Comparator Arm 4: Lenvatinib

Participants will receive lenvatinib as part of the approximately 6.5 year study duration.
의약품: Lenvatinib

Oral Capsule

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants with Adverse Events (AE)s
기간: 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.
Up to Approximately 4 Years
Number of Participants with Change in Vital Signs
기간: Up to Approximately 4 Years

Number of Participants with Change in Vital Signs will be assessed.
Up to Approximately 4 Years
Number of Participants with Change in Electrocardiogram (ECG)
기간: Up to Approximately 4 Years

Number of Participants with Change in ECG will be assessed.
Up to Approximately 4 Years
Number of Participants with Change in Clinical Laboratory Tests
기간: Up to Approximately 4 Years

Number of participants with change in clinical laboratory tests will be assessed.
Up to Approximately 4 Years
Objective Response Rate (ORR)
기간: 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.
Up to Approximately 4 Years

2차 결과 측정

결과 측정
측정값 설명
기간
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-324
기간: Up to Approximately 4 Years

AUC of ABBV-324.
Up to Approximately 4 Years
Maximum Observed Serum Concentration (Cmax) of ABBV-324
기간: Up to Approximately 4 Years

Cmax of ABBV-324.
Up to Approximately 4 Years
Time to Maximum Observed Serum Concentration (Tmax) of ABBV-324
기간: Up to Approximately 4 Years

Tmax of ABBV-324.
Up to Approximately 4 Years
Terminal Elimination Half-Life (t1/2) of ABBV-324
기간: Up to Approximately 4 Years

t1/2 of ABBV-324.
Up to Approximately 4 Years
Antidrug Antibody (ADA)
기간: Up to Approximately 4 Years

Incidence and concentration of anti-drug antibodies.
Up to Approximately 4 Years
Neutralizing Antidrug Antibody (nADA)
기간: Up to Approximately 4 Years

Incidence and concentration of neutralizing anti-drug antibodies.
Up to Approximately 4 Years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

AbbVie

수사관

  • 연구 책임자: ABBVIE INC., AbbVie

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 4월 14일

기본 완료 (추정된)

2030년 9월 1일

연구 완료 (추정된)

2030년 9월 1일

연구 등록 날짜

최초 제출

2025년 2월 28일

QC 기준을 충족하는 최초 제출

2025년 2월 28일

처음 게시됨 (실제)

2025년 3월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 18일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • M25-292
  • 2024-518012-39 (기타 식별자: EU CT)
  • 2024-518012-39-00 (씨티스)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다