A Multicenter, Open-label, Phase II Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Combination With Chemotherapy as First-line Treatment in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study is a multicenter, open-label, phase II study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activities of AK104,a PD-1/CTLA-4 bispecific antibody, in combination with chemotherapy as first-line therapy in subjects with advanced unresectable or metastatic pancreatic ductal adenocarcinoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed.

• Males or females aged ≥ 18 years and ≤ 75 years at the time of signing the ICF.

• Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC).

• Patients have not received prior systemic therapy for locally advanced or metastatic pancreatic cancer; for patients who have received prior induction chemotherapy, concurrent chemoradiotherapy, or adjuvant/neoadjuvant chemotherapy for curative intent, the time between disease progression and last treatment should be at least 6 months.

• Patients have at least one measurable tumor lesion per RECIST v1.1; lesions that received radiotherapy are not selected as target lesions, unless the lesion is the only measurable lesion and has unequivocal progression as judged by imaging, it can be considered as a target lesion.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Expected survival ≥ 3 months.

• Patients who have adequate organ function.

• Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to take effective contraception measures during the study drug administration and within 120 days after the last dose. Male patients with female partners of childbearing potential must agree to take effective contraception measures during the study drug administration and within 120 days after the last dose.

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Zhejiang Provincial People's hospital
RECRUITING
Hangzhou
Shandong Cancer Hospital
RECRUITING
Jinan
Shanghai Changhai Hospital
RECRUITING
Shanghai
Union Hospital Tongji Medical College Huazhong University of Science And Technology
RECRUITING
Wuhan
Contact Information
Primary
Zhifang Yao, MD
clinicaltrials@akesobio.com
+86-0760-89873999
Time Frame
Start Date: 2023-05-25
Estimated Completion Date: 2025-12
Participants
Target number of participants: 78
Treatments
Experimental: AK104 6mg/kg and AG
Experimental: AK104 10mg/kg and AG
Experimental: AK104 and mFOLFIRINOX
Experimental: AK104 and NALIRIFOX
Related Therapeutic Areas
Sponsors
Leads: Akeso

This content was sourced from clinicaltrials.gov

Similar Clinical Trials