Recruiting
Phase 2

AZD0901

Sponsor:

AstraZeneca

Code:

NCT06219941

Conditions

Gastric Cancer

Gastroesophageal Junction Cancer

Biliary Tract Cancer

Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AZD0901

5-Fluorouracil

Leucovorin

l-leucovorin

Irinotecan

Study Details

Brief 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.

Conditions

Gastric Cancer

Gastroesophageal Junction Cancer

Biliary Tract Cancer

Pancreatic Ductal Adenocarcinoma

Study ID

NCT06219941

Start date

Dec 13, 2023

Status verified date

Jul, 2026

Completion date

Jun 28, 2027

Anticipated

Primary completion date

Nov 17, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

226 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sub Study 1 - AZD0901 MONOTHERAPY

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

experimental: 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

experimental: 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.

Interventions

AZD0901

Antibody-drug conjugate/Biologic

5-Fluorouracil

Chemotherapy agents

Leucovorin

Chemotherapy agents

l-leucovorin

Chemotherapy agents

Irinotecan

Chemotherapy agents

Nanoliposomal Irinotecan

Chemotherapy agents

Gemcitabine

Chemotherapy agents

Primary outcome measure

  • 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. [ Time Frame: 30 days post treatment completion. AE Follow Up for 90 days post AZD0901 discontinuation. ]
  • Objective Response Rate (ORR). [ 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). ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Orange, California, United States, 92868

Research Site

Recruiting

Palo Alto, California, United States, 94304

Research Site

Recruiting

Santa Rosa, California, United States, 95403

Research Site

Recruiting

Louisville, Kentucky, United States, 40202

Research Site

Recruiting

Commack, New York, United States, 11725

Research Site

Recruiting

Providence, Rhode Island, United States, 02903

Research Site

Recruiting

Houston, Texas, United States, 77030

Research Site

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Research Site

Recruiting

Montreal, Quebec, Canada, H3G 1A4

Research Site

Recruiting

Sherbrooke, Quebec, Canada, J1G 2E8

More Information

Sponsor

AstraZeneca

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • Gastric cancer
  • Gastroesophageal junction cancer
  • Pancreatic Ductal adenocarcinoma
  • Biliary Tract Cancer
  • Phase II
  • Claudin 18.2
  • AZD0901

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-07-29.