Een onderzoek om bijwerkingen en verandering in ziekteactiviteit van intraveneus (iv) doordrenkte ABBV-324 bij volwassen deelnemers met hepatocellulaire kanker (HCC) of plaveiselcellongkanker (LUSC) (LUSC) (LUSC) (LUSC), intraveneus (LUSC), te beoordelen,
Een fase 1 first-in-mens onderzoek ter evaluatie van veiligheid, farmacokinetiek en werkzaamheid van ABBV 324 bij volwassenen met hepatocellulaire kanker of plaveiselcel niet-kleincellige longkanker
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studiecontact
- Naam: ABBVIE CALL CENTER
- Telefoonnummer: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Studie Locaties
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Werving
- Nanfang Hospital - Southern Medical University /ID# 276916
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, China, 200032
- Werving
- Zhongshan Hospital Fudan University /ID# 276917
-
-
-
-
-
Haifa, Israël, 3109601
- Werving
- Rambam Health Care Campus /ID# 270604
-
Jerusalem, Israël, 91120
- Werving
- Hadassah Medical Center-Hebrew University /ID# 271235
-
-
Central District
-
Petah Tikva, Central District, Israël, 4941492
- Werving
- Rabin Medical Center. /ID# 271236
-
-
-
-
Chiba
-
Kashiwa-shi, Chiba, Japan, 277-8577
- Werving
- National Cancer Center Hospital East /ID# 270585
-
-
Osaka
-
Hirakata-shi, Osaka, Japan, 573-1191
- Werving
- Kansai Medical University Hospital /ID# 272884
-
-
Tokyo
-
Chuo-Ku, Tokyo, Japan, 104-0045
- Werving
- National Cancer Center Hospital /ID# 270583
-
-
-
-
-
San Juan, Puerto Rico, 00927
- Voltooid
- Fdi Clinical Research /ID# 272960
-
-
-
-
-
Madrid, Spanje, 28040
- Werving
- Hospital Universitario Fundacion Jimenez Diaz /ID# 272718
-
Madrid, Spanje, 28050
- Werving
- Hospital Universitario HM Sanchinarro /ID# 272719
-
-
-
-
-
Taipei, Taiwan, 100
- Werving
- National Taiwan University Hospital /ID# 270593
-
-
-
-
California
-
Duarte, California, Verenigde Staten, 91010
- Werving
- City of Hope National Medical Center /ID# 270526
-
Irvine, California, Verenigde Staten, 92618
- Werving
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 276120
-
Los Angeles, California, Verenigde Staten, 90033
- Werving
- USC Norris Comprehensive Cancer Center /ID# 271573
-
Orange, California, Verenigde Staten, 92868
- Werving
- University Of California Irvine Medical Center /ID# 270507
-
Santa Monica, California, Verenigde Staten, 90404
- Werving
- UCLA - Santa Monica /ID# 275995
-
-
Illinois
-
Chicago, Illinois, Verenigde Staten, 60637
- Werving
- University of Chicago Medical Center /ID# 270517
-
-
Missouri
-
St Louis, Missouri, Verenigde Staten, 63110
- Werving
- Washington University /ID# 275757
-
-
New York
-
New York, New York, Verenigde Staten, 10021-3459
- Werving
- Memorial Sloan Kettering Cancer Center /ID# 271228
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Verenigde Staten, 19107
- Werving
- Thomas Jefferson University Sidney Kimmel Cancer Center /ID# 276269
-
-
Tennessee
-
Nashville, Tennessee, Verenigde Staten, 37203
- Werving
- SCRI Oncology Partners /ID# 272750
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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 |
|
Experimenteel: 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 |
|
Experimenteel: 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 |
|
Experimenteel: 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 |
|
Actieve vergelijker: Part 2 Comparator Arm 4: Lenvatinib
Participants will receive lenvatinib as part of the approximately 6.5 year study duration. |
Oral Capsule |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of Participants with Adverse Events (AE)s
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-324
Tijdsspanne: Up to Approximately 4 Years
|
AUC of ABBV-324. |
Up to Approximately 4 Years
|
|
Maximum Observed Serum Concentration (Cmax) of ABBV-324
Tijdsspanne: Up to Approximately 4 Years
|
Cmax of ABBV-324. |
Up to Approximately 4 Years
|
|
Time to Maximum Observed Serum Concentration (Tmax) of ABBV-324
Tijdsspanne: Up to Approximately 4 Years
|
Tmax of ABBV-324. |
Up to Approximately 4 Years
|
|
Terminal Elimination Half-Life (t1/2) of ABBV-324
Tijdsspanne: Up to Approximately 4 Years
|
t1/2 of ABBV-324. |
Up to Approximately 4 Years
|
|
Antidrug Antibody (ADA)
Tijdsspanne: Up to Approximately 4 Years
|
Incidence and concentration of anti-drug antibodies. |
Up to Approximately 4 Years
|
|
Neutralizing Antidrug Antibody (nADA)
Tijdsspanne: Up to Approximately 4 Years
|
Incidence and concentration of neutralizing anti-drug antibodies. |
Up to Approximately 4 Years
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: ABBVIE INC., AbbVie
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- M25-292
- 2024-518012-39 (Andere identificatie: EU CT)
- 2024-518012-39-00 (Ctis)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .