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

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.

Trial Details

NCT ID

NCT06953999

Phase

PHASE3

Sponsor

Akeso

Status

RECRUITING

Cancer Type

Pancreatic Cancer

Interventions

Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine
Ivonescimab, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine
Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine

Locations (sample)

Harbin, Heilongjiang, China|45.75,126.65
Shanghai, Shanghai Municipality, China|31.22222,121.45806
Hangzhou, Zhejiang, China|30.29365,120.16142

Key Eligibility Criteria

Voluntarily sign a written informed consent form.
Age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy of ≥ 3 months.

For full eligibility, visit ClinicalTrials.gov.

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