ANO31905 in Combination With Chemotherapy for CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer
Recruiting now · Phase 1/Phase 2
Conditions studied: Pancreatic Cancer
In brief
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.
Key facts
- Study ID
- NCT07444541
- Run by
- Anova Innovation Limited
- People needed
- 84
- Starts
- 2026-08-01
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-07-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- California Research Institute — Los Angeles, California, United States (enrolling)
Full record on ClinicalTrials.gov
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