AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

Description

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, Pancreatic Adenocarcinoma

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Study Overview

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Study Details

Study overview

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.

A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Tumours Expressing Claudin 18.2.

AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2

Condition
Gastric Cancer
Intervention / Treatment

-

Contacts and Locations

Orange

Research Site, Orange, California, United States, 92868

Palo Alto

Research Site, Palo Alto, California, United States, 94304

Santa Rosa

Research Site, Santa Rosa, California, United States, 95403

Louisville

Research Site, Louisville, Kentucky, United States, 40202

Commack

Research Site, Commack, New York, United States, 11725

Providence

Research Site, Providence, Rhode Island, United States, 02903

Houston

Research Site, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC/GEJC.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2027-01-19