Trials / Completed
CompletedNCT03852251
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
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
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 338 (actual)
- Sponsor
- Akeso · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-01-18
- Primary completion
- 2024-03-25
- Completion
- 2024-03-25
- First posted
- 2019-02-25
- Last updated
- 2024-08-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03852251. Inclusion in this directory is not an endorsement.