A Phase III Study of Ivonescimab + Chemo With/Without AK117 in Metastatic Pancreatic Cancer

Sponsor
Akeso
Study ID
NCT06953999
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine — DRUG
    Ivonescimab: a specified dose and frequency administrated by intravenous infusion (IV). AK117: a specified dose and frequency administrated by intravenous infusion (IV). Albumin-bound Paclitaxel: 125 mg/m2 weekly for 3 weeks followed by 1 week of rest. Gemcitabine: 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest.
  • Ivonescimab, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine — DRUG
    Ivonescimab: a specified dose and frequency administrated by intravenous infusion (IV). AK117 Placebo: a specified dose and frequency administrated by intravenous infusion (IV). Albumin-bound Paclitaxel: 125 mg/m2 weekly for 3 weeks followed by 1 week of rest. Gemcitabine: 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest.
  • Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine — DRUG
    Ivonescimab Placebo : a specified dose and frequency administrated by intravenous infusion (IV). AK117 Placebo : a specified dose and frequency administrated by intravenous infusion (IV). Albumin-bound Paclitaxel: 125 mg/m2 weekly for 3 weeks followed by 1 week of rest. Gemcitabine: 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest.

Study Details

This is a Phase 3, randomized, double-blind clinical trial aimed at evaluating the efficacy and safety of Ivonescimab plus chemotherapy with or without AK117 versus placebo plus chemotherapy in patients with metastatic pancreatic cancer. The study seeks to determine whether the addition of Ivonescimab and/or AK117 improves clinical outcomes compared to standard chemotherapy alone. Participants will be randomly assigned to receive either Ivonescimab with/without AK117 or placebo, both in combination with chemotherapy.

Key Dates

Start date
Jun 11, 2025
Status verified
Mar 2026
Primary completion
May 14, 2027
Completion
May 14, 2028

Study Design

Enrollment
999 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ivonescimab + AK117 + Albumin-bound Paclitaxel + Gemcitabine
  • Experimental: Ivonescimab + AK117 Placebo + Albumin-bound Paclitaxel + Gemcitabine
  • Active Comparator: Ivonescimab Placebo + AK117 Placebo + Albumin-bound Paclitaxel + Gemcitabine

Primary Outcome Measure

Overall response (OS) [ Time Frame: Up to approximately 2 years ]

Central Contacts

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