Recruiting NCT07444541
ANO31905 in Combination With Chemotherapy for CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ANO31905, ANO31905, Nanoparticle Albumin-Bound Paclitaxel, Gemcitabine.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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)]
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- California Research Institute — Los Angeles
Identifiers
NCT: NCT07444541 · ANO31905-204