Une étude pour évaluer les événements indésirables et le changement de l'activité de la maladie des participants adultes infusés par voie intraveineuse (IV) chez les participants adultes atteints d'un cancer de l'hépatocellulaire (HCC) ou de cancer du poumon non à petites cellules squameux (LUSH)
Une étude de phase 1 première à l'humaine évaluant la sécurité, la pharmacocinétique et l'efficacité de l'ABBV 324 chez les adultes atteints d'un cancer hépatocellulaire ou d'un cancer du poumon sans cellules épidermique non à petites cellules
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: ABBVIE CALL CENTER
- Numéro de téléphone: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Lieux d'étude
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Guangdong
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Guangzhou, Guangdong, Chine, 510000
- Recrutement
- Nanfang Hospital - Southern Medical University /ID# 276916
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chine, 200032
- Recrutement
- Zhongshan Hospital Fudan University /ID# 276917
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Madrid, Espagne, 28040
- Recrutement
- Hospital Universitario Fundacion Jimenez Diaz /ID# 272718
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Madrid, Espagne, 28050
- Recrutement
- Hospital Universitario HM Sanchinarro /ID# 272719
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Haifa, Israël, 3109601
- Recrutement
- Rambam Health Care Campus /ID# 270604
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Jerusalem, Israël, 91120
- Recrutement
- Hadassah Medical Center-Hebrew University /ID# 271235
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Central District
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Petah Tikva, Central District, Israël, 4941492
- Recrutement
- Rabin Medical Center. /ID# 271236
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Chiba
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Kashiwa-shi, Chiba, Japon, 277-8577
- Recrutement
- National Cancer Center Hospital East /ID# 270585
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Osaka
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Hirakata-shi, Osaka, Japon, 573-1191
- Recrutement
- Kansai Medical University Hospital /ID# 272884
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Tokyo
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Chuo-Ku, Tokyo, Japon, 104-0045
- Recrutement
- National Cancer Center Hospital /ID# 270583
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San Juan, Porto Rico, 00927
- Complété
- Fdi Clinical Research /ID# 272960
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Taipei, Taïwan, 100
- Recrutement
- National Taiwan University Hospital /ID# 270593
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California
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Duarte, California, États-Unis, 91010
- Recrutement
- City of Hope National Medical Center /ID# 270526
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Irvine, California, États-Unis, 92618
- Recrutement
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 276120
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Los Angeles, California, États-Unis, 90033
- Recrutement
- USC Norris Comprehensive Cancer Center /ID# 271573
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Orange, California, États-Unis, 92868
- Recrutement
- University Of California Irvine Medical Center /ID# 270507
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Santa Monica, California, États-Unis, 90404
- Recrutement
- UCLA - Santa Monica /ID# 275995
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Illinois
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Chicago, Illinois, États-Unis, 60637
- Recrutement
- University of Chicago Medical Center /ID# 270517
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Missouri
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St Louis, Missouri, États-Unis, 63110
- Recrutement
- Washington University /ID# 275757
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New York
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New York, New York, États-Unis, 10021-3459
- Recrutement
- Memorial Sloan Kettering Cancer Center /ID# 271228
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19107
- Recrutement
- Thomas Jefferson University Sidney Kimmel Cancer Center /ID# 276269
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Tennessee
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Nashville, Tennessee, États-Unis, 37203
- Recrutement
- SCRI Oncology Partners /ID# 272750
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
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Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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Hepatocellular cancer (HCC) only: Child-Pugh A classification within 7 days before Cycle 1, Day 1 dosing.
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Laboratory values meeting the criteria outlined in the protocol.
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QT interval corrected for heart rate (QTc) < 470 msec (using Fridericia's correction), no Grade 3 arrythmia, and no other clinically significant cardiac abnormalities.
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Measurable disease per RECIST version 1.1.
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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.
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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:
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Unresolved clinically significant adverse events (AEs) > Grade 1 from prior anticancer therapy except for alopecia.
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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.
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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.
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History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
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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.
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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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Part 1 Dose Escalation: ABBV-324
Participants will receive escalating doses of ABBV-324 as part of the approximately 6.5 year study duration. |
Intravenous (IV) Infusion |
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Expérimental: 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. |
Intravenous (IV) Infusion |
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Expérimental: 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. |
Intravenous (IV) Infusion |
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Expérimental: 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. |
Intravenous (IV) Infusion |
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Comparateur actif: Part 2 Comparator Arm 4: Lenvatinib
Participants will receive lenvatinib as part of the approximately 6.5 year study duration. |
Oral Capsule |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Participants with Adverse Events (AE)s
Délai: Up to Approximately 4 Years
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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
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Number of Participants with Change in Vital Signs
Délai: Up to Approximately 4 Years
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Number of Participants with Change in Vital Signs will be assessed. |
Up to Approximately 4 Years
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Number of Participants with Change in Electrocardiogram (ECG)
Délai: Up to Approximately 4 Years
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Number of Participants with Change in ECG will be assessed. |
Up to Approximately 4 Years
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Number of Participants with Change in Clinical Laboratory Tests
Délai: Up to Approximately 4 Years
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Number of participants with change in clinical laboratory tests will be assessed. |
Up to Approximately 4 Years
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Objective Response Rate (ORR)
Délai: Up to Approximately 4 Years
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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
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-324
Délai: Up to Approximately 4 Years
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AUC of ABBV-324. |
Up to Approximately 4 Years
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Maximum Observed Serum Concentration (Cmax) of ABBV-324
Délai: Up to Approximately 4 Years
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Cmax of ABBV-324. |
Up to Approximately 4 Years
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Time to Maximum Observed Serum Concentration (Tmax) of ABBV-324
Délai: Up to Approximately 4 Years
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Tmax of ABBV-324. |
Up to Approximately 4 Years
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Terminal Elimination Half-Life (t1/2) of ABBV-324
Délai: Up to Approximately 4 Years
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t1/2 of ABBV-324. |
Up to Approximately 4 Years
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Antidrug Antibody (ADA)
Délai: Up to Approximately 4 Years
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Incidence and concentration of anti-drug antibodies. |
Up to Approximately 4 Years
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Neutralizing Antidrug Antibody (nADA)
Délai: Up to Approximately 4 Years
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Incidence and concentration of neutralizing anti-drug antibodies. |
Up to Approximately 4 Years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: ABBVIE INC., AbbVie
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- M25-292
- 2024-518012-39 (Autre identifiant: EU CT)
- 2024-518012-39-00 (Ctis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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