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NCT05827796

IN10018+ Standard Chemotherapy (+KN046) in Subjects With Advanced Pancreatic Cancer

StatusActive, Not Recruiting
PhasePhase 1/2
Primary completion
Track this trial

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 27 words Show 4 more changesShow less
    • Enrollment closed, study ongoing
    • Primary completion date changed from estimate of Dec 31, 2025 to Oct 11, 2025
    • Study completion pushed from Mar 31, 2026 to Dec 31, 2026
    • Site details revised
  2. Primary completion date: Dec 2025 to Dec 31, 2025
    • Study completion date: Mar 2026 to Mar 31, 2026
    v2
  3. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Incidence of Treatment-Related Adverse Events （AEs）
Timeframe: 1 year
To evaluate the objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in subjects with advanced pancreatic cancer.
Timeframe: 2 years

Secondary (5)

Disease Control Rate (DCR) per RECIST 1.1, as evaluated by investigators
duration of response (DoR) per RECIST 1.1, as evaluated by investigators
Progression free survival (PFS) per RECIST 1.1, as evaluated by investigators
Overall survival (OS)
Incidence of Treatment-Related AEs

Arms and interventions

Cohort 1: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine)Experimental

Subjects will be treated with IN10018 25 mg/50 mg/100 mg, once daily, oral+ albumin-bound paclitaxel 125 mg/m2 IV infusion on Days 1 and 8 of each 21-Day Cycle+ gemcitabine 1000 mg/m2 IV infusion on Days 1 and 8 of each 21-Day Cycle.

Cohort 2: IN10018+ standard chemotherapy (albumin-bound paclitaxel + gemcitabine)+KN046Experimental

Subjects will be treated with IN10018 25 mg/50 mg/100 mg, once daily, oral+ albumin-bound paclitaxel 125 mg/m2 IV infusion on Days 2 and 8 of each 21-Day Cycle+ gemcitabine 1000 mg/m2 IV infusion on Days 2 and 9 of each 21-Day Cycle+KN046 5 mg/kg IV infusion on Day 1 of each 21-Day Cycle.

Drugs: IN10018, Albumin-Bound Paclitaxel, Gemcitabine, KN046

Sites

1 site in 1 country

  • Renji Hospital of Shanghai Jiaotong University School of MedicineShanghai, Shanghai Municipality, China