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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Biological: ANO31905; Biological: ANO31905; Drug: Nanoparticle Albumin-Bound Paclitaxel; Drug: Gemcitabine

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Lei Zheng Mays Cancer Center; Phone Number: 210-450-5798; Email: zhengl@uthscsa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Males or females aged ≥ 18 at the time of signing the ICF;
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
3. Expected survival ≥ 3 months;
4. Histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma;
5. At least one measurable lesion according to RECIST v1.1;
6. Tumor tissue samples are determined to be CLDN18.2-positive by immunohistochemistry (IHC) in the central laboratory;
7. Patients with sufficient organ function within 7 days before the first study dose;
8. Non-pregnant or -lactating women.

Exclusion Criteria:

1. 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
2. Any previous systematic anti-cancer therapy;
3. Previous treatment targeting CLDN18.2;
4. Patients with a history of active autoimmune disorders or autoimmune disorders requiring systemic treatment;
5. Patients with known hypersensitivity to any component or excipient of ANO31905, gemcitabine, and nanoparticle albumin-bound paclitaxel;
6. Patients with known metastases to the central nervous system;
7. Patients with severe cardiovascular and cardiovascular diseases;
8. Presence risks of thrombosis or bleeding;
9. 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;
10. Patients with gastrointestinal diseases that are not suitable for enrollment as judged by the investigator;
11. Patients with other conditions that may place the patients at increased undue study-related risks.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ANO31905 (low dose) plus GEM+Nab-P	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).
Experimental: ANO31905 (high dose) plus GEM+Nab-P	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-limiting toxicity (DLT) (Phase Ib).	The severity of adverse events (AEs) will be graded according to the Common Terminology Criteria for Adverse Events Version 6.0 (the severity of cytokine release syndrome [CRS] and immune effector cell-associated neurotoxicity syndrome [ICANS] will be graded per the American Society for Transplantation and Cellular Therapy [ASTCT] consensus criteria). AEs that occur during the DLT observation period and are judged to be "definitely related", "probably related", or "possibly related" to any investigational products (ANO31905, GEM, Nab-P) will be deemed as a DLT event.	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)	Objective response rate (ORR) is defined as the proportion of patients with the best efficacy evaluation of complete response (CR) or partial response (PR) during the study. From date of treatment start until disease progression, date of death or withdrawal from study, whichever came first.	Up to 12 months

Collaborators and Investigators

• Sponsor: Anova Innovation Limited

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Health Care Economics and Organizations; Economics; Gemcitabine; Taxes
• Other Study ID Numbers: ANO31905-204

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No