For Healthcare Professionals

AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

clipboard-pencil

About the study

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.
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Master Inclusion Criteria applicable to both sub studies:


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

Sub study 1 Specific Inclusion criteria:


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

Sub study 2 Specific Inclusion criteria:


  1. Participants diagnosed with histologically confirmed metastatic or advanced PDAC.
  2. Availability of an archival sample or a fresh tumour biopsy taken at screening.
  3. No prior treatments for unresectable or metastatic disease.

EXCLUSION CRITERIA

Master Exclusion Criteria applicable to both sub studies:


  1. 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.
  2. Participants with clinically significant ascites that require drainage.
  3. A history of drug-induced non-infectious ILD/pneumonitis.
  4. Central nervous system metastases or CNS pathology.
  5. Peripheral neuropathy ≥ Grade 2 at screening.
  6. History of another primary malignancy.
  7. Prior exposure to any MMAE-based ADC.
  8. Prior exposure to any CLDN18.2 targeted agents except anti-CLDN18.2 monoclonal antibody.

Sub study 1 Specific Exclusion criteria:


  1. Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC/GEJC.
  2. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.
  3. The use of concomitant medications known to prolong the QT/QTc interval.

Sub study 2 Specific Exclusion criteria:


  1. Known DPD enzyme deficiency based on local testing where testing is SoC.
  2. Use of strong inhibitor or inducer of UGT1A1.
  3. Use of strong inhibitors or inducers of CYP3A4.

pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-877-240-9479Email iconEmail Study Center

Study Details


Contition

Gastric Cancer,Gastroesophageal Junction Cancer,Pancreatic Adenocarcinoma

Age

18+

Phase

PHASE2

Participants Needed

123

Est. Completion Date

Jan 19, 2027

Treatment Type

INTERVENTIONAL


Sponsor

AstraZeneca

ClinicalTrials.gov NCT Identifier

NCT06219941

Study Number

D9800C00001

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to create a personal profile and 
receive news, resources, and alerts 
about clinical trials related to your conditions of interest.