En fas 2-studie av Zanidatamab hos patienter med HER2-uttryckande tumörer
En fas 2, öppen multicenterstudie för att utvärdera effektivitet och säkerhet av Zanidatamab för behandling av deltagare med tidigare behandlade HER2-uttryckande solida tumörer (DiscovHER PAN-206)
The purpose of this study is to evaluate the efficacy and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ overexpression.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studiekontakt
- Namn: Clinical Trial Disclosure & Transparency
- Telefonnummer: 215-832-3750
- E-post: ClinicalTrialDisclosure@JazzPharma.com
Studieorter
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Arizona
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Prescott, Arizona, Förenta staterna, 86301
- Indragen
- Arizona Oncology Associates, PC - NAHOA
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Colorado
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Littleton, Colorado, Förenta staterna, 80120
- Rekrytering
- Rocky Mountain Cancer Center
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Florida
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Fort Myers, Florida, Förenta staterna, 33901
- Indragen
- Florida Cancer Specialists - South
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Orlando, Florida, Förenta staterna, 32827
- Aktiv, inte rekryterande
- Florida Cancer Specialists - Lake Nona
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St. Petersburg, Florida, Förenta staterna, 33705
- Indragen
- Florida Cancer Specialists - North
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West Palm Beach, Florida, Förenta staterna, 33401
- Indragen
- Florida Cancer Specialists - East
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Illinois
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Chicago Ridge, Illinois, Förenta staterna, 60415
- Indragen
- Affiliated Oncologists
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Kansas
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Westwood, Kansas, Förenta staterna, 66205
- Rekrytering
- University of Kansas Cancer Center
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Michigan
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Detroit, Michigan, Förenta staterna, 48201
- Indragen
- Barbara Ann Karmanos Cancer Institute
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New York
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Lake Success, New York, Förenta staterna, 11042
- Rekrytering
- Northwell Health Cancer Institute
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New York, New York, Förenta staterna, 10065
- Rekrytering
- Memorial Sloan Kettering Cancer Center
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Pennsylvania
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Horsham, Pennsylvania, Förenta staterna, 19044
- Indragen
- Alliance Cancer Specialists
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Tennessee
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Knoxville, Tennessee, Förenta staterna, 37909
- Indragen
- Tennessee Cancer Specialists
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Nashville, Tennessee, Förenta staterna, 37203
- Rekrytering
- SCRI Oncology Partners
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Texas
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Amarillo, Texas, Förenta staterna, 79124
- Indragen
- Texas Oncology - West Texas
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Dallas, Texas, Förenta staterna, 75246
- Rekrytering
- Texas Oncology - DFW
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Houston, Texas, Förenta staterna, 77030
- Rekrytering
- MD Anderson Cancer Center
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San Antonio, Texas, Förenta staterna, 78217
- Indragen
- Texas Oncology - San Antonio
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Virginia
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Roanoke, Virginia, Förenta staterna, 24014
- Indragen
- Blue Ridge Cancer Care
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Kutaisi, Georgien, 4600
- Rekrytering
- JSC Vian- Krystyna Kiel Oncology Center
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Tbilisi, Georgien, 0144
- Rekrytering
- Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
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Tbilisi, Georgien, 0112
- Rekrytering
- LTD Todua Clinic
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Tbilisi, Georgien, 0186
- Rekrytering
- Cancer Research Centre
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Tbilisi, Georgien, 0186
- Rekrytering
- LTD Caucasus Medical Centre
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Barcelona, Spanien, 08035
- Rekrytering
- Hospital Universitario Vall d'Hebron
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Barcelona, Spanien, 08036
- Rekrytering
- Hospital Clinic de Barcelona
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Madrid, Spanien, 28034
- Rekrytering
- Hospital Universitario Ramon y Cajal
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Madrid, Spanien, 28041
- Rekrytering
- Hospital Universitario 12 de Octubre
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Málaga, Spanien, 29010
- Rekrytering
- Hospital Regional Universitario de Malaga - Hospital General
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Valencia, Spanien, 46010
- Rekrytering
- INCLIVA, Hospital Clinico Universitario de Valencia
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Las Palmas de Gran Canarias
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Las Palmas, Las Palmas de Gran Canarias, Spanien, 35016
- Rekrytering
- Hospital Universitario Insular Gran Canarias
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Navarre
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Pamplona, Navarre, Spanien, 31008
- Rekrytering
- Complejo Hospitalario de Navarra
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Seoul, Sydkorea, 05505
- Rekrytering
- Asan Medical Center
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Seoul, Sydkorea, 13620
- Rekrytering
- Seoul National University Bundang Hospital
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Seoul, Sydkorea, 04524
- Rekrytering
- The Catholic University of Korea Seoul St. Mary's Hospital
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Gyeonggi-do
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Suwon, Gyeonggi-do, Sydkorea, 10408
- Rekrytering
- National Cancer Center Suwon
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Suwon, Gyeonggi-do, Sydkorea, 10408
- Rekrytering
- The Catholic University of Korea St Vincent's Hospital
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Hwasun-Gun
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Hwasun-Eup, Hwasun-Gun, Sydkorea, 58115
- Rekrytering
- Chonnam National University Hwasun Hospital
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Seoul
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Gangnam-gu, Seoul, Sydkorea, 06351
- Rekrytering
- Samsung Medical Center
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Guro-gu, Seoul, Sydkorea, 04524
- Rekrytering
- Korea University Guro Hospital
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Jongno-gu, Seoul, Sydkorea, 03080
- Rekrytering
- Seoul National University Hospital
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Seodaemun-gu, Seoul, Sydkorea, 03722
- Rekrytering
- Severance Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
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Is at least 18 years of age inclusive at the time of signing the informed consent
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Participants with locally advanced, unresectable, or metastatic solid tumors (except Biliary Tract Cancer (BTC), defined as gallbladder cancer or cholangiocarcinoma) who have progressed following at least 1 prior systemic treatment for metastatic or advanced disease and have no available treatment options that have confirmed benefit. Prior treatment with HER2-targeted therapy is not permitted (Cohort 1 only). For participants with breast cancer (Cohort 2) or GEA (Cohort 3), prior HER2-targeted therapy is permitted and prior therapy with trastuzumab deruxtecan (T-DXd) is required.
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HER2 overexpression (IHC 3+) must be determined by a sponsor designated central laboratory.
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All participants must have adequate tumor sample for submission to allow central HER2 testing.
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Presence of at least 1 measurable lesion as assessed by Independent Central Review (ICR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
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Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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Has a life expectancy of at least 3 months, in the opinion of the investigator.
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Participants with history of treated and stable CNS metastases are eligible, provided the following criteria are met:
- Participants also have measurable metastatic disease with HER2 overexpression (IHC 3+) outside the CNS.
- Participants with treated CNS metastases that are no longer symptomatic may be included in the study if they recovered to < Grade 1 (CTCAE Version 5.0 or higher) or baseline from the acute toxic effect associated with the treatment > 7 days prior to Cycle 1 Day 1.
- Prior stereotactic radiosurgery or stereotactic radiotherapy should be completed at least 7 days (≥ 7 days) before the first dose of study intervention.
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Adequate organ functions.
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Females of childbearing potential must have a negative pregnancy test result.
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Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.
Exclusion Criteria:
- Has known or suspected leptomeningeal disease and/or untreated brain metastasis.
- Has uncontrolled or significant cardiovascular disease
- Has ongoing toxicity related to prior cancer therapy
- Has uncontrolled infection or requiring IV antibiotics, antivirals, or antifungals.
- Has known Human Immunodeficiency Virus (HIV) infection.
- Has active hepatitis B or C infection.
- Has an active SARS-CoV-2 infection.
- Has a history of life-threatening hypersensitivity to monoclonal antibody (mAbs) or to recombinant proteins or excipients in the drug formulation of zanidatamab.
- Has any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site.
- Has any issue or condition that, in the opinion of the investigator, would contraindicate the participant's participation in the study or confound the results of the study.
- Prior treatment with HER2-targeted therapy (Cohort 1 only).
- Has a history of trauma or major surgery
- Was treated with systemic antineoplastic therapy, including hormonal therapies for breast cancer, or any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
- Received zanidatamab at any time prior to the current study.
- Colorectal Cancer (CRC) participants with known KRAS/NRAS and BRAF mutations.
- Non-Small Cell Lung Cancer (NSCLC) participants with known ALK, EGFR mutations and ROS1 fusion.
- Female participants who are breastfeeding or pregnant, and female and male participants planning a pregnancy.
- Prior or concurrent invasive malignancy other than the disease under study, whose natural history or treatment has, in the opinion of the investigator or medical monitor, the potential to interfere with the safety or efficacy assessment of the investigational regimen.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Zanidatamab treatment arm
Eligible participants receiving zanidatamab treatment |
Administered by intravenous (IV) infusion
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Confirmed Objective Response Rate (cORR) per RECIST Version 1.1, as assessed by ICR
Tidsram: Up to 2.5 years
|
The Independent Central Review (ICR) assessed cORR is defined as the proportion of participants who had a best overall response of Complete Response (CR), or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) |
Up to 2.5 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Antal deltagare som rapporterar behandlingsuppkomna biverkningar (TEAE) och allvarliga biverkningar (SAE) enligt betyget NCI CTCAE version 5.0
Tidsram: Upp till 2,5 år
|
Upp till 2,5 år
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|
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Antal deltagare med dosminskningar
Tidsram: Upp till 2,5 år
|
Upp till 2,5 år
|
|
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Antal deltagare som avbryter studiebehandling på grund av TEAE
Tidsram: Upp till 2,5 år
|
Upp till 2,5 år
|
|
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Serumkoncentrationer av Zanidatamab
Tidsram: Upp till 2,5 år
|
Upp till 2,5 år
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|
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Antal deltagare positiva för anti-läkemedelsantikroppar mot Zanidatamab
Tidsram: Upp till 2,5 år
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Upp till 2,5 år
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Antal deltagare som rapporterar symtomatiska biverkningar baserat på patientrapporterade resultat-vanliga terminologikriterier för biverkningar (PRO-CTCAE)
Tidsram: Upp till 2,5 år
|
Upp till 2,5 år
|
|
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Antal deltagare som rapporterar symtomatiska biverkningar baserat på European Organization for Research and Treatment of Cancer (EORTC) Item Library
Tidsram: Upp till 2,5 år
|
Upp till 2,5 år
|
|
|
Andel av alla behandlade deltagare som rapporterar övergripande biverkningsbesvär i den funktionella bedömningen av terapi för kroniska sjukdomar Allmänt fysiskt objekt 5 (FACIT-GP5)
Tidsram: Upp till 2,5 år
|
Upp till 2,5 år
|
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Procentandel av tid då deltagare på behandling rapporterade en hög biverkningsbesvär i den funktionella bedömningen av kronisk sjukdomsterapi General Physical Item 5 (FACIT-GP5)
Tidsram: Upp till 2,5 år
|
Upp till 2,5 år
|
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Duration of Response (DOR) Per RECIST Version 1.1, as assessed by ICR
Tidsram: Up to 2.5 years
|
ICR assessed DOR is defined as the time in months from the first objective response (CR or PR) that is subsequently confirmed to documented progressive disease (PD) per RECIST v1.1 or death from any cause. |
Up to 2.5 years
|
|
cORR by RECIST Version 1.1, as assessed by Investigator
Tidsram: Up to 2.5 years
|
Investigator assessed cORR is defined as the proportion of participants who had a best overall response of Complete Response (CR), or Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) |
Up to 2.5 years
|
|
Duration of Response (DOR) Per RECIST Version 1.1, as assessed by Investigator
Tidsram: Up to 2.5 years
|
Investigator assessed DOR is defined as the time in months from the first objective response (CR or PR) that is subsequently confirmed to documented progressive disease (PD) per RECIST v1.1 or death from any cause. |
Up to 2.5 years
|
|
Time to Response (TTR), as assessed by ICR
Tidsram: Up to 2.5 years
|
ICR assessed TTR is defined as the time from the first dosing date to the first objective response (CR or PR) per RECIST v1.1. |
Up to 2.5 years
|
|
Time to Response (TTR), as assessed by Investigator
Tidsram: Up to 2.5 years
|
Investigator assessed TTR is defined as the time from the first dosing date to the first objective response (CR or PR) per RECIST v1.1. |
Up to 2.5 years
|
|
Disease control rate (DCR), as assessed by ICR
Tidsram: Up to 2.5 years
|
ICR assessed DCR is defined as the proportion of participants whose best overall response (BOR) is confirmed CR, or PR, or stable disease using the RECIST version 1.1 criteria |
Up to 2.5 years
|
|
Disease control rate (DCR), as assessed by Investigator
Tidsram: Up to 2.5 years
|
Investigator assessed DCR is defined as the proportion of participants whose best overall response (BOR) is confirmed CR, or PR, or stable disease using the RECIST version 1.1 criteria |
Up to 2.5 years
|
|
Progression Free Survival (PFS), as assessed by ICR
Tidsram: Up to 2.5 years
|
PFS is defined as the time in months from the first dosing date to the date of first documented disease progression (as assessed by ICR according to RECIST v1.1) or death from any cause, whichever occurs first. |
Up to 2.5 years
|
|
Progression Free Survival (PFS), as assessed by Investigator
Tidsram: Up to 2.5 years
|
PFS is defined as the time in months from the first dosing date to the date of first documented disease progression (as assessed by Investigator according to RECIST v1.1) or death from any cause, whichever occurs first. |
Up to 2.5 years
|
|
Overall Survival (OS)
Tidsram: Up to 3.5 years
|
OS is defined as the time in months from the first dosing date to the date of death due to any cause. |
Up to 3.5 years
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Sjukdomar i det endokrina systemet
- Munsjukdomar
- Stomatogena sjukdomar
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Neoplasmer
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Tarmsjukdomar
- Luftvägssjukdomar
- Neoplasmer efter histologisk typ
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Matsmältningssystemets sjukdomar
- Gastrointestinala sjukdomar
- Magsjukdomar
- Intestinala neoplasmer
- Rektala sjukdomar
- Livmodersjukdomar
- Genitala sjukdomar, kvinnor
- Lungsjukdomar
- Neoplasmer i endokrina körtel
- Neoplasmer i huvud och hals
- Bukspottkörtelsjukdomar
- Neoplasmer, körtel och epitel
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Kolonsjukdomar
- Esofagussjukdomar
- Lungneoplasmer
- Ovariella sjukdomar
- Adnexala sjukdomar
- Genitala neoplasmer, hona
- Gonadal sjukdomar
- Hudsjukdomar
- Bröstsjukdomar
- Carcinom
- Karcinom, bronkogent
- Bronkiella neoplasmer
- Uterina neoplasmer
- Spottkörtelsjukdomar
- Neoplasmer i munnen
- Hud- och bindvävssjukdomar
- Neoplasmer i magen
- Kolorektala neoplasmer
- Esofagusneoplasmer
- Ovariella neoplasmer
- Bröstneoplasmer
- Pankreatiska neoplasmer
- Karcinom, icke-småcellig lunga
- Endometriella neoplasmer
- Karcinom, övergångscell
- Spottkörtelneoplasmer
- zanidatamab
Andra studie-ID-nummer
- JZP598-206
- 2024-516551-41-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
In accordance with ICMJE requirements, Jazz Pharmaceuticals may provide qualified external researchers access to individual participant data (IPD) and clinical trial data that underlie the results of this trial upon request. Qualified researchers can submit a request on https://www.jazzpharma.com/science/clinical-trial-data-sharing/ as outlined. Jazz Pharmaceuticals reserves the right not to consider a request. For inquiries about Jazz's data sharing policy contact clinicaldatasharing@jazzpharma.com.
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