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

NCT06953999 | Recruiting Phase 3 DMC

• 1 other identifier: AK112-310
• Study Type: interventional
• Target: 999
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Overall response (OS)

  Overall Survival (OS) is defined as the time from randomization to death due to any cause.

  Up to approximately 2 years

Secondary Outcomes (8)

• Progression Free Survival (PFS) assessed by investigator per RECIST v1.1

  Up to approximately 2 years

• Objective Response Rate (ORR) assessed by investigator per RECIST v1.1

  Up to approximately 2 years

• Disease Control Rate (DCR) assessed by investigator per RECIST v1.1

  Up to approximately 2 years

• Duration of response (DoR) assessed by the investigator per RECIST v1.1

  Up to approximately 2 years

• Time to response (TTR) assessed by the investigator per RECIST v1.1

  Up to approximately 2 years

Study Arms (3)

Ivonescimab + AK117 + Albumin-bound Paclitaxel + Gemcitabine

EXPERIMENTAL

Drug: Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine

Ivonescimab + AK117 Placebo + Albumin-bound Paclitaxel + Gemcitabine

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

Interventions

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 + AK117 Placebo + Albumin-bound Paclitaxel + Gemcitabine

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 + Albumin-bound Paclitaxel + Gemcitabine

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.

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Histologically or cytologically confirmed, unresectable metastatic pancreatic ductal adenocarcinoma (PDAC).
• No prior systemic anti-cancer treatment for metastatic PDAC.
• At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• Adequate organ function.

You may not qualify if:

• Histologically or cytologically confirmed other types of pancreatic malignancies or mixed histology types.
• Presence of active central nerve system (CNS) metastases.
• Known germline BRCA1/2 or PALB2 mutations.
• Clinically significant or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage.
• History of other malignancies within the past 5 years.
• History of significant bleeding tendencies or coagulopathy; clinically significant bleeding events within 1 month before the first dose.
• Previous anti-angiogenic therapy and immunotherapy.
• Active autoimmune disease requiring systemic treatment within the past 2 years.
• Pregnant or breastfeeding women.
• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (3)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 20032, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Albumin-Bound Paclitaxel; Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Wenting Li

CONTACT

+86-18116403289; wenting01.li@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 1, 2025
• Study Start: June 11, 2025
• Primary Completion (Estimated): May 14, 2027
• Study Completion (Estimated): May 14, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)