NCT07444541 · Anova Innovation Limited
ANO31905 in Combination With Chemotherapy for CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer
What this study is about
The goal of this clinical trial is to assess the safety and effectiveness of ANO31905 in combination with chemotherapy as the first-line treatment for subjects with CLDN18.2-positive locally advanced unresectable or metastatic pancreatic cancer.
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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.
Interventions
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).
Primary outcome measures
Dose-limiting toxicity (DLT) (Phase Ib).
Time frame: At the end of Cycle 1 (each cycle is 28 days)
The severity of adverse events (AEs) will be graded according to the Common Terminology Criteria for Adverse Events Version 6.0. AEs that occur during the DLT observation period and are judged to be "definitely related", "probably related", or "possibly related" to any investigational products will be deemed as a DLT event.
Objective response rate (ORR) assessed by the investigator according to Response Evaluation Criteria for Solid Tumors Version 1.1 (RECIST v1.1) (Phase Ⅱ)
Time frame: Up to 12 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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;
- 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
- Los Angeles, California
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 27, 2026 · Source of record for eligibility and locations