Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:53 PM
Study NCT ID:
NCT03852251
Status:
COMPLETED
Last Update Posted:
2024-08-02
First Post:
2019-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Akeso
Organization:
Study Overview
Official Title:
A Multicenter, Open-label, Phase Ib/II Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Subjects With Advanced Solid Tumors or AK104 in Combination With Oxaliplatin and Capecitabine As First-line Therapy in Subjects With Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
The study consists of a dose escalation and expansion phase (Phase Ib) to determine the recommended Phase 2 dose (RP2D) for AK104 in combination with oxaliplatin and capecitabine, and a dose confirmation phase (Phase II) which will further characterize the treatment of AK104 in combination at the RP2D.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: