AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

Last updated: March 17, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

2

Condition

Pancreatic Disorders

Gall Bladder Cancer

Stomach Cancer

Treatment

Irinotecan

Gemcitabine

5-Fluorouracil

Clinical Study ID

NCT06219941
D9800C00001
  • Ages > 18
  • All Genders

Study Summary

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

Inclusion

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 signingthe 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 weeksprior 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. Priorneoadjuvant/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 ofbiliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) andgallbladder carcinoma (NOTE: Ampullary cancers are not eligible).

  • Documented radiographic or clinical disease progression on or after at least oneprior regimen and maximum 2 prior lines of systemic treatment for unresectable ormetastatic disease.

Master Exclusion Criteria applicable to all sub studies:

  • Unstable or active peptic ulcer disease or digestive tract bleeding including butnot limited to clinically significant bleeding in the setting of prior CLDN18.2directed 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 monoclonalantibody.

Exclusion

Sub study 1 Specific Exclusion criteria:

  • Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) orindeterminate GC/GEJC unless they have failed/not tolerated/or are not eligible forstandard 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 isSoC.

Sub study 3 Specific Exclusion criteria

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

Study Design

Total Participants: 190
Treatment Group(s): 7
Primary Treatment: Irinotecan
Phase: 2
Study Start date:
December 13, 2023
Estimated Completion Date:
December 31, 2026

Study Description

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.

Connect with a study center

  • Research Site

    Melbourne, 3000
    Australia

    Active - Recruiting

  • Research Site

    Murdoch, WA6150
    Australia

    Active - Recruiting

  • Research Site

    Randwick, 2031
    Australia

    Active - Recruiting

  • Research Site

    Kingston, Ontario K7L 2V7
    Canada

    Site Not Available

  • Research Site

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Research Site

    Montreal, Quebec H3G 1A4
    Canada

    Active - Recruiting

  • Research Site

    Sherbrooke, Quebec J1G 2E8
    Canada

    Active - Recruiting

  • Research Site

    Tbilisi, 0112
    Georgia

    Active - Recruiting

  • Research Site

    Chuo-ku, 104-0045
    Japan

    Active - Recruiting

  • Research Site

    Kashiwa, 227-8577
    Japan

    Active - Recruiting

  • Research Site

    Kitaadachi-gun, 362-0806
    Japan

    Active - Recruiting

  • Research Site

    Koto-ku, 135-8550
    Japan

    Active - Recruiting

  • Research Site

    Nagoya-shi, 464-8681
    Japan

    Active - Recruiting

  • Research Site

    Osakasayama-shi, 589-8511
    Japan

    Active - Recruiting

  • Research Site

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Research Site

    George Town, 10450
    Malaysia

    Active - Recruiting

  • Research Site

    Johor Bahru, 81100
    Malaysia

    Active - Recruiting

  • Research Site

    Kuala Lumpur, 59100
    Malaysia

    Active - Recruiting

  • Research Site

    Kuching, 93586
    Malaysia

    Active - Recruiting

  • Research Site

    Selangor, 62250
    Malaysia

    Active - Recruiting

  • Research Site

    Chisinau, MD-2025
    Moldova, Republic of

    Active - Recruiting

  • Research Site

    Kraków, 31-501
    Poland

    Active - Recruiting

  • Research Site

    Warszawa, 02-034
    Poland

    Active - Recruiting

  • Research Site

    Bukit Merah, 169610
    Singapore

    Active - Recruiting

  • Research Site

    Singapore, 308433
    Singapore

    Active - Recruiting

  • Research Site

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Research Site

    Madrid, 28007
    Spain

    Active - Recruiting

  • Research Site

    Kaohsiung, 80756
    Taiwan

    Active - Recruiting

  • Research Site

    Taichung, 404
    Taiwan

    Active - Recruiting

  • Research Site

    Tainan City, 70403
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei City, 11217
    Taiwan

    Active - Recruiting

  • Research Site

    Taoyuan, 00333
    Taiwan

    Active - Recruiting

  • Research Site

    Glasgow, G12 0YN
    United Kingdom

    Site Not Available

  • Research Site

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • Research Site

    London, NW3 2QG
    United Kingdom

    Site Not Available

  • Research Site

    Oxford, OX3 7LE
    United Kingdom

    Site Not Available

  • Research Site

    Orange, California 92868
    United States

    Active - Recruiting

  • Research Site

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Research Site

    Santa Rosa, California 95403
    United States

    Active - Recruiting

  • Research Site

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Research Site

    Commack, New York 11725
    United States

    Active - Recruiting

  • Research Site

    Providence, Rhode Island 02903
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77030
    United States

    Active - Recruiting

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