ANO31905 in Combination With Chemotherapy for CLDN18.2-Positive Locally Advanced Unresectable or Metastatic Pancreatic Cancer

Sponsor
Anova Innovation Limited
Study ID
NCT07444541
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ANO31905 — BIOLOGICAL
    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 — BIOLOGICAL
    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 — DRUG
    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 — DRUG
    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 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
May 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

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