Clinical trial · Interventional
A Phase Ib/II Study of AK104 and AK117 in Combination With or Without Chemotherapy in Advanced Malignant Tumors
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
NCT05235542CI-TRIAL-00114427completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Tumors | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| AK104 | Drug | — | UNRESOLVED |
| AK117 | Drug | — | UNRESOLVED |
| Capecitabine tablets | Drug | Capecitabine | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Paclitaxel | Drug |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Phase Ib#Dosage regimen 1#
- description
- Subjects receive AK104 plus AK117 every 3- week cycle (Q3W) until progression
- interventionNames
- Drug: AK104
- Drug: AK117
- type
- EXPERIMENTAL
- label
- Phase Ib#Dosage regimen 2#
- description
- Subjects receive AK104 plus AK117 every 6- week cycle (Q6W) until progression
- interventionNames
- Drug: AK104
- Drug: AK117
- type
- EXPERIMENTAL
- label
- Phase II#Cohort 1#
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 to 75 years old. 2. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 3. Have a life expectancy of at least 3 months. 4. Phase Ib: Histologically or cytologically confirmed advanced solid tumor. 5. Phase II: Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma or Esophageal squamous cell carcinoma. 6. Have at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator. 7. Has adequate organ function. Exclusion Criteria: 1. Undergone major surgery within 30 days prior to the first dose of study treatment. 2. Active central nervous system (CNS) metastases. 3. History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs). 4. Active Hepatitis B or Hepatitis C. 5. Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity. 6. History of severe bleeding tendency or coagulation disorder.
References
Publications (0)
Data not yet available
No reference posted for this study.