Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

AZD0901 in partecipanti con tumori solidi avanzati che esprimono Claudin18.2

28 settembre 2026 aggiornato da: AstraZeneca

Uno studio multicentrico di Fase II, in aperto, per valutare la sicurezza, la tollerabilità, l'efficacia, la farmacocinetica e l'immunogenicità di AZD0901 come monoterapia e in combinazione con agenti antitumorali in partecipanti con tumori solidi avanzati che esprimono claudin 18.2.

The purpose of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and immunogenicity of AZD0901 as monotherapy and in combination with anti-cancer agents in participants with locally advanced unresectable or metastatic solid tumours expressing CLDN18.2 .

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This open-label, multi-centre study consists of individual sub studies, each evaluating the safety and tolerability of AZD0901.

Sub study 1 will investigate the safety, tolerability, and anti-tumour activity of AZD0901 monotherapy in participants with advanced or metastatic gastric esophageal cancer expressing CLDN18.2. Participants will receive AZD0901 monotherapy via intravenous (IV) infusion and will be randomised in to one of 2 arms.

Sub study 2 will consist of two parts, a safety run-in and a dose expansion part to investigate the safety and efficacy of AZD0901 in combination with different chemotherapy agents in participants with pancreatic cancer. Substudy 3 will investigate the safety, tolerability, and anti-tumour activity of AZD0901 monotherapy in participants with advanced or metastatic Biliary tract cancer.

Tipo di studio

Interventistico

Iscrizione (Stimato)

226

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Australia
      • Melbourne, Australia, 3000
        • Reclutamento
        • Research Site
      • Murdoch, Australia, WA6150
        • Reclutamento
        • Research Site
      • Randwick, Australia, 2031
        • Reclutamento
        • Research Site
  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Ritirato
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Reclutamento
        • Research Site
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Reclutamento
        • Research Site
      • Sherbrooke, Quebec, Canada, J1G 2E8
        • Reclutamento
        • Research Site
  • Cina
      • Changsha, Cina, 410013
        • Non ancora reclutamento
        • Research Site
      • Chengdu, Cina, 610041
        • Non ancora reclutamento
        • Research Site
  • Corea del Sud
      • Gyeonggi-do, Corea del Sud, 13620
        • Reclutamento
        • Research Site
      • Seoul, Corea del Sud, 03080
        • Reclutamento
        • Research Site
      • Seoul, Corea del Sud, 06351
        • Reclutamento
        • Research Site
      • Seoul, Corea del Sud, 05505
        • Reclutamento
        • Research Site
      • Seoul, Corea del Sud, 03722
        • Reclutamento
        • Research Site
  • Georgia
      • Tbilisi, Georgia, 0112
        • Reclutamento
        • Research Site
  • Giappone
      • Chūōku, Giappone, 104-0045
        • Reclutamento
        • Research Site
      • Kashiwa, Giappone, 227-8577
        • Reclutamento
        • Research Site
      • Kitaadachi-gun, Giappone, 362-0806
        • Reclutamento
        • Research Site
      • Kōtoku, Giappone, 135-8550
        • Reclutamento
        • Research Site
      • Nagoya, Giappone, 464-8681
        • Reclutamento
        • Research Site
      • Osakasayama-shi, Giappone, 589-8511
        • Reclutamento
        • Research Site
  • Malaysia
      • George Town, Malaysia, 10450
        • Reclutamento
        • Research Site
      • Johor Bahru, Malaysia, 81100
        • Completato
        • Research Site
      • Kuala Lumpur, Malaysia, 59100
        • Reclutamento
        • Research Site
      • Kuala Selangor, Malaysia, 62250
        • Reclutamento
        • Research Site
      • Kuching, Malaysia, 93586
        • Reclutamento
        • Research Site
  • Moldavia
      • Chisinau, Moldavia, MD-2025
        • Reclutamento
        • Research Site
  • Polonia
      • Krakow, Polonia, 31-501
        • Reclutamento
        • Research Site
      • Warsaw, Polonia, 02-034
        • Reclutamento
        • Research Site
  • Regno Unito
      • Glasgow, Regno Unito, G12 0YN
        • Ritirato
        • Research Site
      • Leeds, Regno Unito, LS9 7TF
        • Ritirato
        • Research Site
      • London, Regno Unito, NW3 2QG
        • Ritirato
        • Research Site
      • Oxford, Regno Unito, OX3 7LE
        • Ritirato
        • Research Site
  • Singapore
      • Bukit Merah, Singapore, 169610
        • Reclutamento
        • Research Site
      • Singapore, Singapore, 308433
        • Reclutamento
        • Research Site
      • Singapore, Singapore, 119074
        • Reclutamento
        • Research Site
      • Singapore, Singapore, 329563
        • Reclutamento
        • Research Site
  • Spagna
      • Barcelona, Spagna, 08035
        • Reclutamento
        • Research Site
      • Madrid, Spagna, 28007
        • Reclutamento
        • Research Site
      • Madrid, Spagna, 28040
        • Reclutamento
        • Research Site
  • Stati Uniti
    • California
      • Orange, California, Stati Uniti, 92868
        • Reclutamento
        • Research Site
      • Palo Alto, California, Stati Uniti, 94304
        • Reclutamento
        • Research Site
      • Santa Rosa, California, Stati Uniti, 95403
        • Reclutamento
        • Research Site
    • Kentucky
      • Louisville, Kentucky, Stati Uniti, 40202
        • Reclutamento
        • Research Site
    • New York
      • Commack, New York, Stati Uniti, 11725
        • Reclutamento
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02903
        • Reclutamento
        • Research Site
    • Texas
      • Houston, Texas, Stati Uniti, 77030
        • Reclutamento
        • Research Site
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Reclutamento
        • Research Site
      • Taichung, Taiwan, 404
        • Reclutamento
        • Research Site
      • Tainan, Taiwan, 70403
        • Reclutamento
        • Research Site
      • Taipei, Taiwan, 11217
        • Reclutamento
        • Research Site
      • Taoyuan, Taiwan, 00333
        • Reclutamento
        • Research Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

The list below is a summarised eligibility criteria for the study - refer to the study protocol for full criteria.

Master Inclusion Criteria applicable to all sub studies:

  • Participant must be ≥ 18 years or the legal age of consent at the time of signing the ICF.
  • Participants who are CLDN18.2 positive.
  • Must have at least one measurable lesion according to RECIST v1.1.
  • ECOG performance status of 0 to 1 with no deterioration over the previous 2 weeks prior first day of dosing.
  • Predicted life expectancy of ≥ 12 weeks.
  • Adequate organ and bone marrow function as defined by protocol.
  • Body weight > 35 kg.
  • Participants are willing to comply with contraception requirements.

Sub study 1 Specific Inclusion criteria:

  • Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.
  • Advanced or metastatic GC/GEJC.
  • Maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.

Sub study 2 Specific Inclusion criteria:

  • Participants diagnosed with histologically confirmed metastatic or advanced PDAC.
  • Availability of an archival sample or a fresh tumour biopsy taken at screening.
  • No prior treatments for unresectable or metastatic disease. Prior neoadjuvant/adjuvant chemotherapy is permitted as long as participants progressed ≥ 6 months (183 days) from the last dose.

Sub study 3 Specific Inclusion criteria

  • Histologically confirmed, unresectable advanced, or metastatic adenocarcinoma of biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma (NOTE: Ampullary cancers are not eligible).
  • Documented radiographic or clinical disease progression on or after at least one prior regimen and maximum 2 prior lines of systemic treatment for unresectable or metastatic disease.

Master Exclusion Criteria applicable to all sub studies:

  • Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.
  • Participants with clinically significant ascites that require drainage.
  • A history of drug-induced non-infectious ILD/pneumonitis.
  • Central nervous system metastases or CNS pathology.
  • Peripheral neuropathy, sensory, or motor ≥ Grade 2 at screening.
  • History of another primary malignancy.
  • Prior exposure to any MMAE-based ADC.
  • Prior exposure to any CLDN18.2 targeted agents except anti-CLDN18.2 monoclonal antibody.

Sub study 1 Specific Exclusion criteria:

  • Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC/GEJC unless they have failed/not tolerated/or are not eligible for standard anti-HER2 therapy, where available.
  • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.
  • The use of concomitant medications known to prolong the QT/QTc interval.

Sub study 2 Specific Exclusion criteria:

  • Known DPD enzyme deficiency based on local testing where testing is SoC.
  • Use of strong inhibitor or inducer of UGT1A1.
  • Use of strong inhibitors or inducers of CYP3A4.
  • Known homozygous for the UGT1A1*28 allele based on local testing where testing is SoC.

Sub study 3 Specific Exclusion criteria

• Clinically significant biliary obstruction that has not resolved before enrollment.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Sub Study 1 - AZD0901 MONOTHERAPY

Sub Study 1 will investigate AZD0901 monotherapy in order to evaluate the safety, tolerability, and efficacy of AZD0901.
Droga: AZD0901

Antibody-drug conjugate/Biologic

Altri nomi:
  • CMG901
Sperimentale: Sub Study 2 - AZD0901 IN COMBINATION WITH ANTI-CANCER AGENTS IN PANCREATIC DUCTAL ADENOCARCINOMA

Substudy 2 will investigate the safety and efficacy of AZD0901 as first line systemic treatment used in combination with different chemotherapy agents
Droga: AZD0901

Antibody-drug conjugate/Biologic

Altri nomi:
  • CMG901
Droga: 5-Fluorouracil

Chemotherapy agents

Altri nomi:
  • 5-FU
Droga: Leucovorin

Chemotherapy agents

Altri nomi:
  • LV
Droga: l-leucovorin

Chemotherapy agents

Altri nomi:
  • I-LV
Droga: Irinotecan

Chemotherapy agents

Altri nomi:
  • Camptosar
Droga: Nanoliposomal Irinotecan

Chemotherapy agents

Altri nomi:
  • ONIVIDE
Droga: Gemcitabine

Chemotherapy agents

Altri nomi:
  • Gemzar
Sperimentale: Sub Study 3: AZD0901 MONOTHERAPY IN BILIARY TRACT CANCER

Substudy 3 Further evaluate the preliminary anti-tumour activity of AZD0901 monotherapy by assessment of DRR.
Droga: AZD0901

Antibody-drug conjugate/Biologic

Altri nomi:
  • CMG901

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of adverse events (AEs), serious AEs (SAEs). Changes from baseline in clinical laboratory parameters, vital signs, ECGs and physical examination. Rate of AEs leading to discontinuation of AZD0901, Occurrence of DLTs.
Lasso di tempo: 30 days post treatment completion. AE Follow Up for 90 days post AZD0901 discontinuation.

To investigate the safety and tolerability, of AZD0901 monotherapy or in combination with anti-cancer agents in particpants with advanced or metastatic solid tumours expressing CLDN18.2.
30 days post treatment completion. AE Follow Up for 90 days post AZD0901 discontinuation.
Objective Response Rate (ORR).
Lasso di tempo: From date of first dose of AZD0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).

Proportion of participants with a confirmed Complete Response (CR) or Partial Response (PR) as determined by the Investigator at local site as per RECIST v1.1.
From date of first dose of AZD0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS)
Lasso di tempo: From date of first dose/randomisation until the date of death due to any cause (approximately 2 years).

The analysis will include all dosed/randomised participants as assigned/randomised. All deaths will be included, regardless of whether the participant withdraws from therapy or receives another anticancer therapy.
From date of first dose/randomisation until the date of death due to any cause (approximately 2 years).
Progression Free Survival (PFS)
Lasso di tempo: From date of first dose/randomisation until disease progression or death in the absence of progression (approximately 2 years).

Progression-free survival is defined as the time date of randomisation or enrollment until progression per RECIST v1.1 as assessed by the Investigator at local site, or death due to any cause, regardless of whether the participant withdraws from randomized therapy, receives another anti-cancer therapy or clinically progresses prior to RECIST v1.1 progression.
From date of first dose/randomisation until disease progression or death in the absence of progression (approximately 2 years).
Duration of Response (DoR)
Lasso di tempo: From the date of first documented confirmed response until date of documented progression (approximately 2 years).

The time from the date of first documented confirmed response until date of first documented progression per RECIST v1.1 or death due to any cause.
From the date of first documented confirmed response until date of documented progression (approximately 2 years).
Disease control rate (DCR)
Lasso di tempo: Up to 11 weeks post date of first dose/randomisation

The percentage of participants who have a confirmed CR or PR or who have SD per RECIST v1.1 as assessed by the Investigator at local site and derived from the raw tumour data up to 11 weeks after date of first dose/randomisation.
Up to 11 weeks post date of first dose/randomisation
Percentage change in tumor size
Lasso di tempo: From start through to study completion.

The best percentage change from baseline in tumor size is the largest decrease (or smallest increase) from baseline for a participant, using RECIST v1.1 assessments.
From start through to study completion.
Serum concentration of AZD0901 (total ADC), total antibody (conjugated and unconjugated) and total unconjugated MMAE
Lasso di tempo: From date of first dose of AZD0901 up until 90 days post AZD0901 discontinuation.

To characterise the PK of AZD0901 monotherapy or in combination with anti cancer agents in participants with advanced or metastatic solid tumours expressing CLDN18.2.
From date of first dose of AZD0901 up until 90 days post AZD0901 discontinuation.
Serum PK parameters of AZD0901, total antibody (conjugated and unconjugated) and MMAE including but not limited to AUC, Cmax, tmax, clearance and half-life, as data allow.
Lasso di tempo: From date of first dose of AZD0901 up until 90 days post AZD0901 discontinuation.

To characterise the PK of AZD0901 monotherapy or in combination with anti cancer agents in participants with advanced or metastatic solid tumours expressing CLDN18.2.
From date of first dose of AZD0901 up until 90 days post AZD0901 discontinuation.
Clinical activity by baseline and/or on-treatment tissue-based biomarkers including, but not limited to, gene expression, mutation profiles, DNA damage, protein expression, immune response and/or mechanisms of resistance.
Lasso di tempo: From date of first dose of AZD0901 up to 7 weeks.

To investigate baseline and/or on-treatment tissue-based RNA, DNA, and/or proteins, and association with clinical activity of AZD0901 (substudy 1).
From date of first dose of AZD0901 up to 7 weeks.
ADA status will be determined along with prevalence and incidence of anti-drug antibodies to AZD0901, and titer established.
Lasso di tempo: From date of first dose of AZD0901 up until 90 days post AZD0901 discontinuation.

To determine the immunogenicity of AZD0901 monotherapy or in combination with anti-cancer agents in participants with advanced or metastatic solid tumours expressing CLDN18.2.
From date of first dose of AZD0901 up until 90 days post AZD0901 discontinuation.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AstraZeneca

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

13 dicembre 2023

Completamento primario (Stimato)

17 novembre 2026

Completamento dello studio (Stimato)

28 giugno 2027

Date di iscrizione allo studio

Primo inviato

21 novembre 2023

Primo inviato che soddisfa i criteri di controllo qualità

12 gennaio 2024

Primo Inserito (Effettivo)

23 gennaio 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • D9800C00001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Periodo di condivisione IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Criteri di accesso alla condivisione IPD

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi