Studie av det terapeutiska paret RYZ811 (diagnostisk) och RYZ801 (terapeutisk) för att identifiera och behandla försökspersoner med GPC3+ icke-operabelt HCC (GPC3)
Fas 1/1b enkelarm, öppen prövning av Theranostic Pair RYZ811 (diagnostisk) och RYZ801 (terapeutisk) för att identifiera och behandla försökspersoner med GPC3+ icke-operabelt hepatocellulärt karcinom (HCC)
Phase 1/2 randomized, controlled, open-label trial of theranostic pair RYZ811 (diagnostic) and RYZ801 (therapeutic) to identify and treat subjects with GPC3+ unresectable hepatocellular carcinoma (HCC)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
- Fas 1
Kontakter och platser
Studiekontakt
- Namn: RayzeBio Clinical Trials
- Telefonnummer: 1-619-657-0057
- E-post: clinicaltrials@rayzebio.com
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294
- Rekrytering
- Research Facility
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Arizona
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Phoenix, Arizona, Förenta staterna, 85054
- Rekrytering
- Research Facility
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California
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Orange, California, Förenta staterna, 92868
- Rekrytering
- Research Facility
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Florida
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Jacksonville, Florida, Förenta staterna, 32224
- Rekrytering
- Research Facility
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40536
- Rekrytering
- Research Facility
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Maryland
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Baltimore, Maryland, Förenta staterna, 21287
- Rekrytering
- Research Facility
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Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Rekrytering
- Research Facility
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Missouri
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St Louis, Missouri, Förenta staterna, 63104
- Rekrytering
- Research Facility
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Nebraska
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Omaha, Nebraska, Förenta staterna, 68130
- Rekrytering
- Research Facility
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New York
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New York, New York, Förenta staterna, 10065
- Rekrytering
- Research Facility
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Texas
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Houston, Texas, Förenta staterna, 77030
- Rekrytering
- Research Facility
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Virginia
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Charlottesville, Virginia, Förenta staterna, 22908
- Rekrytering
- Research Facility
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Washington
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Seattle, Washington, Förenta staterna, 98109
- Rekrytering
- Research Facility
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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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Age of at least 18 years at the time of signing the informed consent form (ICF)
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Histologically/cytologically confirmed diagnosis of HCC.
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Barcelona Clinic Liver Cancer (BCLC) Stage C or BCLC Stage B not amenable to locoregional therapy
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Child-Pugh A
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Eastern Cooperative Oncology Group (ECOG) performance status (PS 0-1)
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Disease progression after 1 prior systemic therapy for unresectable HCC
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Measurable disease per RECIST v1.1
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Sufficient renal function
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Adequate hematologic function
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Adequate hepatic function
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The subject must have recovered from toxicities related to prior treatments to ≤Grade 1, unless clinically nonsignificant and/or stable on supportive therapy
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If HBV or HCV infection: Disease managed per local practice; antiviral treatment is allowed.
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Gastric or esophageal varices previously treated with endoscopic therapy according to institutional standards are permitted if no clinically significant bleeding
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For women of childbearing potential (WOCBP):
- Negative serum pregnancy test within 48 hours prior to the first dose of RYZ811
- Agreement to use barrier contraception and a second form of highly effective contraception
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For sexually active males:
- Must use a condom during intercourse
- Male subjects whose sexual partners are WOCBP must also agree to use a second form of highly effective contraception
- A condom is required to be used also by vasectomized men
Exclusion Criteria:
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Subjects with fibrolamellar carcinoma, sarcomatoid HCC or combined hepatocellular cholangiocarcinoma
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Prior liver transplantation
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Known hypersensitivity to 68Ga, 225Ac or any of the excipients of RYZ811 or RYZ801
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Portal vein tumor thrombosis classified as Vp4
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Documented hepatic encephalopathy within 6 months of enrollment
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Clinically meaningful ascites within 6 months of enrollment
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Prior EBRT to the liver within 12 weeks prior to receiving RYZ811
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Prior liver radioembolization
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Previously treated central nervous system (CNS) metastasis without recovery from acute side effects
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Documented history of idiopathic pulmonary fibrosis (IPF), interstitial lung disease (ILD) or pneumonitis
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Uncontrolled significant intercurrent illness including, but not limited to:
- QT interval corrected for heart rate using Fridericia's formula (QTcF) >470 ms
- Hemoglobin A1c (Hgb A1c) ≥8%
- Uncontrolled hypertension
- Dose Expansion only: Prior treatment with lenvatinib is exclusionary
- Significant cardiovascular disease or heart failure
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History of clinically significant bleeding
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Prior participation in any interventional clinical study
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Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
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Have a history of primary malignancy within the past 3 years other than (1) HCC, (2) adequately treated carcinoma in situ or non-melanoma carcinoma of the skin, (3) any other curatively treated malignancy that is not expected to require treatment for recurrence during participation in the study, or (4) an untreated cancer on active surveillance that may not affect the subject's survival status for >3 years
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Subject requires other treatment that in the opinion of the Investigator would be more appropriate than what is offered in the study
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Pregnancy or breastfeeding
Note: Additional criteria may apply and will be assessed by the study site
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Dosupptrappning, Dosexpansion (Dosoptimering/Randomiserad fas 2)
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Ga-68 Ac-225 |
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Aktiv komparator: Standard of Care (SoC) (Randomiserad Fas 2)
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Ga-68 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Therapeutic - RYZ801
Tidsram: Rate of DLTs during the first 42 days of study treatment
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To determine the RTA of RYZ801 in subjects with GPC3+ unresectable HCC (Dose Escalation only) |
Rate of DLTs during the first 42 days of study treatment
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Therapeutic - RYZ801
Tidsram: From enrollment for up to three months or study discontinuation, whichever occurs first.
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To determine if treatment with RYZ801, compared to SoC therapy, improves ORR in subjects with GPC3+ unresectable HCC (Dose Expansion Stage 2 only) using ORR (rate of CR or PR), as determined by BICR according to RECIST v1.1 |
From enrollment for up to three months or study discontinuation, whichever occurs first.
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Therapeutic - RYZ801
Tidsram: From enrollment to 3months after randomization or study discontinuation, whichever occurs first.
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To evaluate ORR of RYZ801 different dosing regimens (Dose Expansion Stage 1 only) and determine dosage optimized RP2D using ORR (rate of confirmed CR or PR) by RECIST v1.1 per investigator assessment |
From enrollment to 3months after randomization or study discontinuation, whichever occurs first.
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Diagnostic - RYZ811
Tidsram: Baseline, pre-injection and post-injection up to 6 days post injection.
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To assess the safety and tolerability of RYZ811 in subjects with unresectable HCC. Safety and tolerability of RYZ811 as measured by incidence and severity of AEs, including SAEs, laboratory changes, and other safety findings. |
Baseline, pre-injection and post-injection up to 6 days post injection.
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Diagnostic - RYZ811
Tidsram: RYZ811 biodistribution to be assessed on the day of injection.
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To evaluate the biodistribution of RYZ811 in subjects with unresectable HCC. SUV (mean, maximum and peak) of organs and tumors; volume of RYZ811 avid uptake in tumor lesions; and tumor-to-normal organ tracer uptake ratios. |
RYZ811 biodistribution to be assessed on the day of injection.
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Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Freddy Escorcia, MD, PhD, RayzeBio, Inc.
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
- Patologiska processer
- Neoplasmer efter plats
- Neoplasmer
- Neoplasmer efter histologisk typ
- Neoplasmer i matsmältningssystemet
- Matsmältningssystemets sjukdomar
- Leversjukdomar
- Neoplasmer, körtel och epitel
- Adenocarcinom
- Neoplasmer i levern
- Carcinom
- Patologiska tillstånd, tecken och symtom
- Karcinom, hepatocellulärt
- Sjukdom
Andra studie-ID-nummer
- RYZ801-101
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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