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

Phase 3

Not yet recruiting

• Conditions: Pancreatic Cancer
• Interventions: Drug: Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine; Drug: Ivonescimab, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine; Drug: Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine

• Registration Number: NCT06953999
• Lead Sponsor: Akeso

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-04-24
• Study First Submitted QC: 2025-04-24
• Last Update Submitted: 2025-04-24
• Study First Posted: 2025-05-01
• Last Update Posted: 2025-05-01
• Study Start: 2025-05-14
• Primary Completion: 2027-05-14
• Study Completion: 2028-05-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 999

Inclusion Criteria

1. Voluntarily sign a written informed consent form.
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

1. Histologically or cytologically confirmed other types of pancreatic malignancies or mixed histology types.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ivonescimab + AK117 + Albumin-bound Paclitaxel + Gemcitabine	Ivonescimab, AK117, Albumin-bound Paclitaxel, Gemcitabine	-
Ivonescimab + AK117 Placebo + Albumin-bound Paclitaxel + Gemcitabine	Ivonescimab, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine	-
Ivonescimab Placebo + AK117 Placebo + Albumin-bound Paclitaxel + Gemcitabine	Ivonescimab Placebo, AK117 Placebo, Albumin-bound Paclitaxel, Gemcitabine	-

Primary Outcome Measures

Name	Time	Method
Overall response (OS)	Up to approximately 2 years	Overall Survival (OS) is defined as the time from randomization to death due to any cause.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) assessed by investigator per RECIST v1.1	Up to approximately 2 years	PFS is defined as the time from randomization to the first documented disease progression (per RECIST v1.1 criteria) assessed by investigators or death due to any cause, whichever occurs first.
Objective Response Rate (ORR) assessed by investigator per RECIST v1.1	Up to approximately 2 years	ORR is the proportion of subjects with complete response(CR) or partial response(PR) , assessed by investigators based on RECIST v1.1.
Disease Control Rate (DCR) assessed by investigator per RECIST v1.1	Up to approximately 2 years	Disease control rate (DCR) assessed according to RECIST v1.1.
Duration of response (DoR) assessed by the investigator per RECIST v1.1	Up to approximately 2 years	Duration of response (DoR) assessed according to RECIST v1.1.
Adverse Events (AEs)	Up to approximately 2 years	An AE is any untoward medical occurrence in a participant, temporarily associated with the use of study treatment, whether or not considered related to the study treatment.
Cmax and Cmin	Up to approximately 2 years	AK112 serum drug concentrations in subjects at different time points after AK112 administration.
Anti-drug antibodies (ADA)	Up to approximately 2 years	Number of subjects with detectable anti-drug antibodies (ADA).
Time to response (TTR) assessed by the investigator per RECIST v1.1	Up to approximately 2 years	Time to response (TTR) is defined as the time to response based on RECIST v1.1.

Trial Locations

Locations (2)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China