NCT07444541

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

A Phase Ib/Ⅱ Clinical Study to Evaluate the Safety and Efficacy of ANO31905 for Injection in Combination With Chemotherapy as the First-line Treatment for Patients With CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Anova Innovation Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	ANO31905	The initial dose is 500 μg/kg Q2W. The drug will be administered on D1/D15 of each cycle. The maximum duration of administration is tentatively set at 2 years.
BIOLOGICAL	ANO31905	ANO31905: If the lower dose is tolerated, a higher dose of 800 μg/kg will be administered to the subjects. ANO31905 will be administered on D1/D15 of each cycle. The maximum duration of administration is tentatively set at 2 years.
DRUG	Nanoparticle Albumin-Bound Paclitaxel	125 mg/m\^2, intravenous infusion, D1/D8/D15 per cycle until PD, intolerable toxicity, or other discontinuation criteria specified in the protocol (whichever occurs first).
DRUG	Gemcitabine	1000 mg/m\^2, intravenous infusion, D1/D8/D15 per cycle until PD, intolerable toxicity, or other discontinuation criteria specified in the protocol (whichever occurs first).

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-08-01
• Completion: 2028-12-01
• First posted: 2026-03-03
• Last updated: 2026-04-16

Regulatory

• FDA-regulated drug study