Study on ANO31905 with Chemotherapy for Advanced Pancreatic Cancer with CLDN18.2 Marker

Sponsor: Anova Innovation Limited

Sponsor score: 0

ClinicalTrials ID:NCT07444541

Provider View

This clinical trial is testing a new treatment combining ANO31905 with chemotherapy for patients with advanced pancreatic cancer that cannot be surgically removed or has spread. The study aims to determine if this combination is safe and effective as a first treatment option.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new drug, ANO31905, when used with chemotherapy as the first treatment for patients with advanced pancreatic cancer that cannot be removed by surgery or has spread to other parts of the body. The cancer must have a specific marker called CLDN18.2 for patients to participate.

Eligibility Criteria

Inclusion Criteria

  • Men and women aged 18 or older.
  • Good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Expected to live at least 3 more months.
  • Confirmed diagnosis of pancreatic ductal adenocarcinoma.
  • At least one tumor that can be measured by scans.
  • Tumor must test positive for the CLDN18.2 marker.
  • Must have good organ function as shown by recent tests.
  • Women must not be pregnant or breastfeeding.

Exclusion Criteria

  • Have had other cancers besides pancreatic adenocarcinoma in the last 5 years.
  • Have received any previous anti-cancer treatments.
  • Have had treatments targeting the CLDN18.2 marker before.
  • Have active autoimmune disorders or need treatment for autoimmune disorders.
  • Have allergies to any ingredients in ANO31905, gemcitabine, or paclitaxel.
  • Have cancer that has spread to the brain or spinal cord.
  • Have severe heart or blood vessel diseases.
  • Have a high risk of blood clots or bleeding.
  • Have received live vaccines in the last 28 days or plan to during the study.
  • Have gastrointestinal diseases that make participation unsuitable.
  • Have other conditions that increase risks related to the study.

Locations

FACILITYZIPCITYSTATE
California Research Institute90027Los AngelesCalifornia

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