- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07680582
An Exploratory Study of Personalized Cancer Vaccine in Adjuvant Therapy of Solid Tumors
1. juli 2026 opdateret af: Ruijin Hospital
An Exploratory Study of Personalized Cancer Vaccine (ABO2109) in Adjuvant Therapy of Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of ABO2109 in combination with toripalimab, and to evaluate the immunogenicity, pharmacokinetics, pharmacodynamics, as well as biomarker characteristics of the investigational cancer vaccine.
In addition, the antitumor activity of ABO2109 will be assessed during both dose exploration and expansion stages, the accumulative data will support the clinical development of ABO2109.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
60
Fase
- Tidlig fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Xinjing Wang
- Telefonnummer: 18817821319
- E-mail: newvista89@163.com
Studiesteder
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200025
- Rekruttering
- Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
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Kontakt:
- Xinjing Wang
- Telefonnummer: 18817821319
- E-mail: newvista89@163.com
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Key Inclusion Criteria:
- ≥18 years of age at time of informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
- Life expectancy of ≥6 months
- Patient diagnosed with solid tumors and is receiving perioperative and/or adjuvant anti-cancer therapy, or patients with advanced solid tumors
- No evidence of disease progression per investigator within 28 days before the first dose of study intervention
- Sufficient organ function
- Female patients must meet both of the criteria: a) Surgically sterile, or postmenopausal for ≥2 years, or women of childbearing potential with a negative pregnancy test and willing to use effective contraception during the study and for at least 90 days after the last study dose. Use of progesterone-containing contraceptives is not permitted. b) Agree not to breastfeed during the study and for at least 90 days after the last study dose.Male patients must meet the following criteria:If not surgically sterile and potentially engaging in sexual activity that could lead to pregnancy, agree to use effective contraception during the study and for at least 90 days after the last study dose.
Key Exclusion Criteria:
- For perioperative or adjuvant therapy setting, participants have received systemic anti-tumor treatment previously
- Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that has been cured, or superficial bladder cancer, carcinoma in situ of the breast, carcinoma in situ of the cervix, thyroid cancer
- Presence of active or prior history of interstitial lung disease, tuberculosis, or any other condition known to compromise pulmonary function.
- Presence of active infections
- History of severe cardiovascular or cerebrovascular diseases occurring within 6-month prior to study treatment
- Known hypersensitivity to the active ingredients or excipients of ABO2109 or toripalimab.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Dose Exploration Part
For participants in dose exploration, the first treatment cycle consists of ABO2109 monotherapy, and combination therapy with tgripalimab is initiated from the second treatment cycle onwards.For participants in dose expansion,will receive ABO2109 in combination therapy with tgripalimab since the first treatment cycle AB02109 will be administered at specified dose defined in the study protocol via an intramuscular(lM)injection on Day 1 of each 21-day cycle for up to 9 cycles, tgripalimak will be administered via intravenous (lV) infusion on Day 1 of each 21-day cycle until progression,unacceptable toxicity,or up to 13 cycles whichever is sooner.
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personalized cancer vaccine
Anti-PD-1 monoclonal antibody
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Incidence and nature of dose-limiting toxicity (DLT) with ABO2109 monotherapy (Dose Exploration)
Tidsramme: From the first dose of ABO2109 through 21 days post-dose for each dose-escalation cohort
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From the first dose of ABO2109 through 21 days post-dose for each dose-escalation cohort
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Incidence and severity of TEAE, TESAE, and TEAE leading to study treatment interruption or premature discontinuation following study treatment (Dose Exploration)
Tidsramme: From the start of study intervention until 30 days after the last dose of ABO2109/90 days after the last dose of toripalimab, or until the initiation of new antineoplastic therapy, whichever occurs first
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From the start of study intervention until 30 days after the last dose of ABO2109/90 days after the last dose of toripalimab, or until the initiation of new antineoplastic therapy, whichever occurs first
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Changes in ECOG performance status score (Dose Exploration)
Tidsramme: From baseline until 30 days after the last dose of ABO2109/90 days after the last dose of toripalimab, or until the initiation of new antineoplastic therapy, whichever occurs first.
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From baseline until 30 days after the last dose of ABO2109/90 days after the last dose of toripalimab, or until the initiation of new antineoplastic therapy, whichever occurs first.
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Disease-Free Survival (DFS) based on RECIST Version 1.1. (Dose Expansion)
Tidsramme: 5 years
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5 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Baiyong Shen, Ruijin Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
9. juni 2026
Primær færdiggørelse (Anslået)
30. juni 2026
Studieafslutning (Anslået)
9. februar 2031
Datoer for studieregistrering
Først indsendt
18. marts 2026
Først indsendt, der opfyldte QC-kriterier
1. juli 2026
Først opslået (Faktiske)
2. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juli 2026
Sidst verificeret
1. marts 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ABO2109-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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 .
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Sorrento Therapeutics, Inc.Trukket tilbageSolid tumor | Recidiverende solid tumor | Refraktær tumor
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EMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyAfsluttetSolid tumor | Avanceret solid tumorSpanien, Forenede Stater, Holland, Det Forenede Kongerige
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Impact Therapeutics, Inc.RekrutteringSolid tumor | Avanceret solid tumorKina, Australien, Taiwan, Forenede Stater
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Partner Therapeutics, Inc.Trukket tilbageSolid tumor | Solid tumor, voksenForenede Stater
Kliniske forsøg med ABO2109 Injection
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Jiangsu HengRui Medicine Co., Ltd.Ikke rekrutterer endnu
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Grand Medical Pty Ltd.Aktiv, ikke rekrutterende
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Beijing Boren HospitalAfsluttetAvanceret solid tumor | Recidiverende/refraktær lymfomKina
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Staidson (Beijing) Biopharmaceuticals Co., LtdAfsluttetAcute respiratory distress syndromKina
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Jiangsu Kanion Pharmaceutical Co., LtdBeijing Bionovo Medicine Development Co., Ltd.Afsluttet
-
Ruijin HospitalShanghai Essight Bio Co.,LtdRekruttering
-
Bio-Thera SolutionsAfsluttet
-
GE HealthcareRekrutteringOnkologi | Ondartet fast tumorHolland
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Shengjing HospitalJiangsu HengRui Medicine Co., Ltd.RekrutteringHR Positiv/HER2 lav brystkræftKina
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Jeffrey S HeierKato Pharmaceuticals, Inc.AfsluttetVitreomakulær trækkraft | Vitreomakulær vedhæftning | Vitreomakulær vedhæftningForenede Stater