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A Study of AK104 With Chemotherapy as First-line Treatment in Patients With Advanced Pancreatic Cancer

NCT05859750 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-12-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

AK104

AK104 (6mg/kg) on day 1, IV, Q2W

DRUG

AK104

AK104 (10mg/kg) on day 1, IV, Q2W

DRUG

Gemcitabine

Gemcitabine (1000mg/m2) on days 1, 8 and 15, IV, Q4W

DRUG

Nab-Paclitaxel

Nab-Paclitaxel (125mg/m2) on days 1, 8 and 15, IV, Q4W

DRUG

Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil/Calcium folinate

liposomal irinotecan 50 mg/m², oxaliplatin 60 mg/m², leucovorin 400 mg/m², and fluorouracil 2400 mg/m², administered sequentially as a continuous intravenous infusion over 46 h

DRUG

Oxaliplatin + Irinotecan + 5-Fluorouracil/Leucovorin

oxaliplatin, 85 mg/m²; irinotecan, 180 mg/m²; leucovorin, 400 mg/m²; and fluorouracil, 400 mg/m² given as a bolus followed by 2400 mg per square meter given as a 46-hour continuous infusion, every 2 weeks

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-25
Primary Completion
2025-06-30
Completion
2025-12-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05859750 on ClinicalTrials.gov