Health Trials

AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

ConditionsGastric CancerGastroesophageal Junction CancerBiliary Tract CancerPancreatic Ductal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • AZD0901

    Drug

    Antibody-drug conjugate/Biologic

  • 5-Fluorouracil

    Drug

    Chemotherapy agents

  • Leucovorin

    Drug

    Chemotherapy agents

  • l-leucovorin

    Drug

    Chemotherapy agents

  • Irinotecan

    Drug

    Chemotherapy agents

  • Nanoliposomal Irinotecan

    Drug

    Chemotherapy agents

  • Gemcitabine

    Drug

    Chemotherapy agents

Treatment groups

226 Participants
are divided into 3 treatment groups
Group A: Sub Study 1 - AZD0901 MONOTHERAPYExperimental treatment 1 intervention
Group B: Sub Study 2 - AZD0901 IN COMBINATION WITH ANTI-CANCER AGENTS IN PANCREATIC DUCTAL ADENOCARCINOMAExperimental treatment 7 interventions
Group C: Sub Study 3: AZD0901 MONOTHERAPY IN BILIARY TRACT CANCERExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

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.

Time frame
30 days post treatment completion. AE Follow Up for 90 days post AZD0901 discontinuation.
2

Objective Response Rate (ORR).

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.

Time frame
From date of first dose of AZD0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years).

Secondary outcomes

1

Overall Survival (OS)

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.

Time frame
From date of first dose/randomisation until the date of death due to any cause (approximately 2 years).
2

Progression Free Survival (PFS)

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.

Time frame
From date of first dose/randomisation until disease progression or death in the absence of progression (approximately 2 years).
3

Duration of Response (DoR)

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.

Time frame
From the date of first documented confirmed response until date of documented progression (approximately 2 years).
4

Disease control rate (DCR)

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.

Time frame
Up to 11 weeks post date of first dose/randomisation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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