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.
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.
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).
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).
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Dose-limiting toxicity (DLT) (Phase Ib). — 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) — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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