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
Sponsor: Akeso
Listed as NCT03852251, this PHASE1/PHASE2 trial focuses on Advanced Solid Tumors and Gastric Adenocarcinoma and remains completed. Sponsored by Akeso, it has been updated 6 times since 2019, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)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.
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.
Status Flow
Change History
6 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE1/PHASE2
Status: Active Not Recruiting → Completed
-
Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
-
Nov 2022 — Jul 2024 [monthly]
Active Not Recruiting PHASE1_PHASE2
Status: Unknown Status → Active Not Recruiting
-
Oct 2021 — Nov 2022 [monthly]
Unknown Status PHASE1_PHASE2
Status: Recruiting → Unknown Status
-
Jan 2021 — Oct 2021 [monthly]
Recruiting PHASE1_PHASE2
▶ Show 1 earlier version
-
Mar 2019 — Jan 2021 [monthly]
Recruiting PHASE1_PHASE2
First recorded
Jan 2019
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Akeso
- Akeso Pharmaceuticals, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .