A Phase III Study of Ivonescimab + Chemo With/Without AK117 vs Chemo in Metastatic Pancreatic Cancer
NCT ID: NCT06953999
Last Updated: 2025-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
999 participants
INTERVENTIONAL
2025-05-14
2028-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ivonescimab + AK117 + Albumin-bound Paclitaxel + Gemcitabine
Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine
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
Ivonescimab, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine
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
Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine
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.
Interventions
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Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine
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
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
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.
Eligibility Criteria
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Inclusion Criteria
2. Age at enrollment is ≥ 18 and ≤ 75 years, both males and females are eligible.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Life expectancy of ≥ 3 months.
5. Histologically or cytologically confirmed, unresectable metastatic pancreatic ductal adenocarcinoma (PDAC).
6. No prior systemic anti-cancer treatment for metastatic PDAC.
7. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
8. Adequate organ function.
Exclusion Criteria
2. Presence of active central nerve system (CNS) metastases.
3. Known germline BRCA1/2 or PALB2 mutations.
4. Clinically significant or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage.
5. History of other malignancies within the past 5 years.
6. History of significant bleeding tendencies or coagulopathy; clinically significant bleeding events within 1 month before the first dose.
7. Previous anti-angiogenic therapy and immunotherapy.
8. Active autoimmune disease requiring systemic treatment within the past 2 years.
9. Pregnant or breastfeeding women.
10. Concurrent participation in another clinical trial, unless it is an observational or non-interventional study or in the follow-up phase of an interventional study.
18 Years
75 Years
ALL
No
Sponsors
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Akeso
INDUSTRY
Responsible Party
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Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AK112-310
Identifier Type: -
Identifier Source: org_study_id
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