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A Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, for Advanced Solid Tumors or With mXELOX/XELOX as First-line Therapy for Advanced Gastric or GEJ Adenocarcinoma

NCT03852251 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2024-08-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, pharmacodynamics (PD) and anti-tumor activities of AK104，a PD-1/CTLA-4 bispecific antibody, when administered as a single agent in adults subjects with advanced or metastatic solid tumors, or combined with oxaliplatin and capecitabine as first-line therapy in adult subjects with advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Conditions

Interventions

BIOLOGICAL

AK104

Subjects will receive AK104 by intravenous administration.

DRUG

Oxaliplatin

Subjects will receive AK104 in combination with oxaliplatin and capecitabine.

DRUG

Capecitabine

Subjects will receive AK104 in combination with oxaliplatin and capecitabine.

Sponsors & Collaborators

  • Akeso Pharmaceuticals, Inc.

    collaborator OTHER

  • Akeso

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2019-01-18
Primary Completion
2024-03-25
Completion
2024-03-25

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 NCT03852251 on ClinicalTrials.gov