Who is eligible for clinical trial NCT07444541?

Participants must meet protocol criteria for Pancreatic Cancer. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07444541 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-23

ANO31905 in Combination With Chemotherapy for CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer (NCT07444541)

🟢 Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Anova Innovation Limited

🩺 Plain-English Summary (8th-Grade Level)

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 join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (12 items).

Location: California Research Institute — Los Angeles, California

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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;
Previous treatment targeting CLDN18.2;
Patients with a history of active autoimmune disorders or autoimmune disorders requiring systemic treatment;
Patients with known hypersensitivity to any component or excipient of ANO31905, gemcitabine, and nanoparticle albumin-bound paclitaxel;
Patients with known metastases to the central nervous system;
Patients with severe cardiovascular and cardiovascular diseases;
Presence risks of thrombosis or bleeding;
Patients who have received attenuated live vaccines within 28 days before the first study dose or are expected to receive attenuated live vaccines during study treatment;
Patients with gastrointestinal diseases that are not suitable for enrollment as judged by the investigator;
Patients with other conditions that may place the patients at increased undue study-related risks.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

California Research Institute — Los Angeles, California

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗