ANO31905 in Combination With Chemotherapy for CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Anova Innovation Limited
- Study ID
- NCT07444541
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ANO31905 — BIOLOGICALThe 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 — BIOLOGICALANO31905: 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 — DRUG125 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 — DRUG1000 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 Details
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.
Key Dates
- First listed
- Mar 3, 2026
- Start date
- Aug 31, 2026
- Status verified
- Apr 2026
- Primary completion
- Aug 31, 2027
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 84 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: ANO31905 (low dose) plus GEM+Nab-P
- Experimental: ANO31905 (high dose) plus GEM+Nab-P
Primary Outcome Measure
Dose-limiting toxicity (DLT) (Phase Ib). [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
Central Contacts
- Lei Zheng Mays Cancer Center210-450-5798
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| California Research Institute | Los Angeles | California | 90027 |
Find similar trials in Los Angeles, CA
By condition
By specialty
By research site
Related Studies
- American Hepato-Pancreato-Biliary Association (AHPBA) Pancreatic Irreversible Electroporation (IRE) RegistryRecruiting · University of Louisville · Birmingham, Alabama
- APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid TumorsPHASE2 · Recruiting · Apollomics Inc. · Los Angeles, California
- VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or LymphomaPHASE1/PHASE2 · Recruiting · VM Oncology, LLC · Santa Rosa, California
- UCSF PANC Cyst RegistryRecruiting · University of California, San Francisco · San Francisco, California