ANO31905 in Combination With Chemotherapy for CLDN18.2-Positive Locally Advanced Unresectable or … (NCT07444541) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
ANO31905 in Combination With Chemotherapy for CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer
84 participantsStarted 2026-05
Plain-language summary
The goal of this clinical trial is to assess the safety and efficacy of ANO31905 in combination with chemotherapy as the first-line treatment for subjects with CLDN18.2-positive locally advanced unresectable or metastatic pancreatic cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males or females aged ≥ 18 at the time of signing the ICF;
. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
. Expected survival ≥ 3 months;
. Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma;
. At least one measurable lesion according to RECIST v1.1;
. Tumor tissue samples are determined to be CLDN18.2-positive by immunohistochemistry (IHC) in the central laboratory;
. Patients with sufficient organ function within 7 days before the first study dose;
. Non-pregnant or -lactating women.
Exclusion criteria
. Patients with other malignant tumors except pancreatic adenocarcinoma within 5 years before the first dose of the study treatment; Any previous systematic anti-cancer therapy
. Any previous systematic anti-cancer therapy;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose-limiting toxicity (DLT) (Phase Ib).
Timeframe: At the end of Cycle 1 (each cycle is 28 days)
2
Objective response rate (ORR) assessed by the investigator according to Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1) (Phase Ⅱ)