Undersøgelse af det terapeutiske par RYZ811 (diagnostisk) og RYZ801 (terapeutisk) til at identificere og behandle forsøgspersoner med GPC3+ uoperabelt HCC (GPC3)
Fase 1/1b enkeltarm, åbent forsøg med Theranostic Pair RYZ811 (diagnostisk) og RYZ801 (terapeutisk) til identifikation og behandling af forsøgspersoner med GPC3+ uoperabelt hepatocellulært 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)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: RayzeBio Clinical Trials
- Telefonnummer: 1-619-657-0057
- E-mail: clinicaltrials@rayzebio.com
Studiesteder
-
-
Alabama
-
Birmingham, Alabama, Forenede Stater, 35294
- Rekruttering
- Research Facility
-
-
Arizona
-
Phoenix, Arizona, Forenede Stater, 85054
- Rekruttering
- Research Facility
-
-
California
-
Orange, California, Forenede Stater, 92868
- Rekruttering
- Research Facility
-
-
Florida
-
Jacksonville, Florida, Forenede Stater, 32224
- Rekruttering
- Research Facility
-
-
Kentucky
-
Lexington, Kentucky, Forenede Stater, 40536
- Rekruttering
- Research Facility
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21287
- Rekruttering
- Research Facility
-
-
Minnesota
-
Rochester, Minnesota, Forenede Stater, 55905
- Rekruttering
- Research Facility
-
-
Missouri
-
St Louis, Missouri, Forenede Stater, 63104
- Rekruttering
- Research Facility
-
-
Nebraska
-
Omaha, Nebraska, Forenede Stater, 68130
- Rekruttering
- Research Facility
-
-
New York
-
New York, New York, Forenede Stater, 10065
- Rekruttering
- Research Facility
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- Rekruttering
- Research Facility
-
-
Virginia
-
Charlottesville, Virginia, Forenede Stater, 22908
- Rekruttering
- Research Facility
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98109
- Rekruttering
- Research Facility
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
-
Age of at least 18 years at the time of signing the informed consent form (ICF)
-
Histologically/cytologically confirmed diagnosis of HCC.
-
Barcelona Clinic Liver Cancer (BCLC) Stage C or BCLC Stage B not amenable to locoregional therapy
-
Child-Pugh A
-
Eastern Cooperative Oncology Group (ECOG) performance status (PS 0-1)
-
Disease progression after 1 prior systemic therapy for unresectable HCC
-
Measurable disease per RECIST v1.1
-
Sufficient renal function
-
Adequate hematologic function
-
Adequate hepatic function
-
The subject must have recovered from toxicities related to prior treatments to ≤Grade 1, unless clinically nonsignificant and/or stable on supportive therapy
-
If HBV or HCV infection: Disease managed per local practice; antiviral treatment is allowed.
-
Gastric or esophageal varices previously treated with endoscopic therapy according to institutional standards are permitted if no clinically significant bleeding
-
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
-
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:
-
Subjects with fibrolamellar carcinoma, sarcomatoid HCC or combined hepatocellular cholangiocarcinoma
-
Prior liver transplantation
-
Known hypersensitivity to 68Ga, 225Ac or any of the excipients of RYZ811 or RYZ801
-
Portal vein tumor thrombosis classified as Vp4
-
Documented hepatic encephalopathy within 6 months of enrollment
-
Clinically meaningful ascites within 6 months of enrollment
-
Prior EBRT to the liver within 12 weeks prior to receiving RYZ811
-
Prior liver radioembolization
-
Previously treated central nervous system (CNS) metastasis without recovery from acute side effects
-
Documented history of idiopathic pulmonary fibrosis (IPF), interstitial lung disease (ILD) or pneumonitis
-
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
-
History of clinically significant bleeding
-
Prior participation in any interventional clinical study
-
Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study
-
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
-
Subject requires other treatment that in the opinion of the Investigator would be more appropriate than what is offered in the study
-
Pregnancy or breastfeeding
Note: Additional criteria may apply and will be assessed by the study site
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Dosiseskalering, Dosisudvidelse (Dosisoptimering/Randomiseret fase 2)
|
Ga-68 Ac-225 |
|
Aktiv komparator: Standardbehandling (SoC) (Randomiseret fase 2)
|
Ga-68 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Therapeutic - RYZ801
Tidsramme: Rate of DLTs during the first 42 days of study treatment
|
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
|
|
Therapeutic - RYZ801
Tidsramme: From enrollment for up to three months or study discontinuation, whichever occurs first.
|
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.
|
|
Therapeutic - RYZ801
Tidsramme: From enrollment to 3months after randomization or study discontinuation, whichever occurs first.
|
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.
|
|
Diagnostic - RYZ811
Tidsramme: Baseline, pre-injection and post-injection up to 6 days post injection.
|
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.
|
|
Diagnostic - RYZ811
Tidsramme: RYZ811 biodistribution to be assessed on the day of injection.
|
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.
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Freddy Escorcia, MD, PhD, RayzeBio, Inc.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Neoplasmer efter sted
- Neoplasmer
- Neoplasmer efter histologisk type
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Leversygdomme
- Neoplasmer, kirtel og epitel
- Adenocarcinom
- Neoplasmer i leveren
- Karcinom
- Patologiske tilstande, tegn og symptomer
- Carcinom, hepatocellulært
- Sygdom
Andre undersøgelses-id-numre
- RYZ801-101
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .