ANO31905 with Chemotherapy for CLDN18.2-Positive Pancreatic Cancer
This study is testing a new treatment called ANO31905 combined with standard chemotherapy (Nanoparticle Albumin-Bound Paclitaxel and Gemcitabine) for people with pancreatic cancer that has spread or cannot be removed by surgery. This specific type of pancreatic cancer is called CLDN18.2-positive. Researchers want to see how safe and effective this combination treatment is. To join, you must be at least 18 years old, have a good general health status, and your cancer must be CLDN18.2-positive. The study aims to find the best dose of ANO31905 and measure how many participants respond to the treatment. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 84 participants. The phase of the study is not specified.
- What's involved
- Participants will receive ANO31905 and chemotherapy on specific days of each cycle, potentially for up to 2 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure how well participants respond to treatment for up to 12 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
ANO31905 in Combination With Chemotherapy for CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Dose-limiting toxicity (DLT) (Phase Ib).At the end of Cycle 1 (each cycle is 28 days)
The severity of adverse events (AEs) will be graded according to the Common Terminology Criteria for Adverse Events Version 6.0. AEs that occur during the DLT observation period and are judged to be "definitely related", "probably related", or "possibly related" to any investigational products will be deemed as a DLT event.
- Objective response rate (ORR) assessed by the investigator according to Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1) (Phase Ⅱ)Up to 12 months
Objective response rate (ORR) is defined as the proportion of patients with the best efficacy evaluation of complete response (CR) or partial response (PR) during the study. From date of treatment start until disease progression, date of death or withdrawal from study, whichever came first.