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 range18 Years

SexALL

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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;
✕. 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;

What they're measuring

Dose-limiting toxicity (DLT) (Phase Ib).

Timeframe: At the end of Cycle 1 (each cycle is 28 days)

Objective response rate (ORR) assessed by the investigator according to Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1) (Phase Ⅱ)

Timeframe: Up to 12 months

Trial details

NCT IDNCT07444541

SponsorAnova Innovation Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

Lei Zheng Mays Cancer Center

210-450-5798 zhengl@uthscsa.edu

View on ClinicalTrials.gov More Pancreatic Cancer trials