At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 128 enrolled / 128 target

Drug / intervention

AK104 +8 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05235542

NCT05235542Phase 1CompletedHigh Momentum (2.5/mo)Completion was 1mo ago

Compare CT.gov

A Phase Ib/II Study of AK104#PD-1 / CTLA-4 Bispecific Antibody# and AK117#Anti-CD47 Antibody# in Combination With or Without Chemotherapy in Advanced Malignant Tumors

Akeso·interventional·Posted Feb 11, 2022·Updated Jun 11, 2026

In Brief

A Phase 1 clinical trial evaluating AK104, AK117, and 7 other interventions for Advanced Malignant Tumors. Completed, enrolled 128 participants across 1 site.

Signals

Enrolling ahead of pace

Detailed Summary

Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) and AK117#AntiCD47 Antibody# combined with or without chemotherapy in advanced malignant tumors

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAdvanced Malignant Tumors

CountriesChina

Collaborators--

Timeline

Phase 1CompletedFinished

20222023202420252026

First PostedFeb 2022

Enrollment StartMar 2022

Primary CompletionMay 2026

TodayJul 2026

First PostedFeb 11, 2022

Enrollment StartMar 12, 2022

Primary CompletionMay 9, 2026

TodayJul 2, 2026

Enrollment to primary: 4.2 yearsPosted 4.4 years ago

Arms & Interventions

Phase Ib#Dosage regimen 1#experimental

Subjects receive AK104 plus AK117 every 3- week cycle (Q3W) until progression

Drug: AK104Drug: AK117

Phase Ib#Dosage regimen 2#experimental

Subjects receive AK104 plus AK117 every 6- week cycle (Q6W) until progression

Drug: AK104Drug: AK117

Phase II#Cohort 1#experimental

Gastric Cancer or Gastroesophageal Junction Cancer: AK104 + XELOX (Oxaliplatin + Capecitabine)+AK117 every 3- week cycle (Q3W) until progression

Drug: AK104Drug: AK117Drug: Capecitabine tabletsDrug: Oxaliplatin

Phase II#Cohort 2#experimental

Esophageal squamous cell cancer: AK104 + 5-FU/Paclitaxel+Cisplatin± AK117 every 3- week cycle (Q3W) until progression

Drug: AK104Drug: AK117Drug: CisplatinDrug: PaclitaxelDrug: 5-FU

Phase II#Cohort 3#experimental

Gastric Cancer or Gastroesophageal Junction Cancer or Esophageal squamous cell cancer: AK117 +Paclitaxel/Docetaxel/Irinotecan every 3- or 4- week cycle (Q3W or Q4W) until progression

Drug: AK117Drug: PaclitaxelDrug: IrinotecanDrug: Docetaxel