Clinical trial · Interventional
A Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer
A Phase II Clinical Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer
NCT07114315CI-TRIAL-00104423recruitingPhase 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)
This is an open-label, multi-center phase II clinical study consisting of two parts: Part I: To evaluate the safety and efficacy of AK130 combined with AK112 in advanced pancreatic cancer. Part II: To evaluate the safety and efficacy of AK112, either as monotherapy or in combination with AK130, in advanced pancreatic cancer.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK112 | Drug | — | UNRESOLVED |
| AK130 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AK112 in combination with AK130
- interventionNames
- Drug: AK112
- Drug: AK130
- type
- EXPERIMENTAL
- label
- AK112
- interventionNames
- Drug: AK112
Primary outcomes (2)
- measure
- Number of subjects with adverse events (AEs)
- timeFrame
- From the time of informed consent signed through 30 days after the last dose of study drug or starting new anti-cancer therapy.
- description
- AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Be able and willing to provide written informed consent. * Have a life expectancy of at least 3 months. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Subjects with histologically or cytologically confirmed advanced/metastatic pancreatic ductal adenocarcinoma (PDAC), who have progressed on ≤2 prior lines of systemic therapy. * According to RECIST v1.1, there is at least one measurable lesion. * Has adequate organ function. * All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 90 days after the last dose of study treatment. * Able to to comply with all requirements of study participation (including all study procedures). Exclusion Criteria: * Except for PDAC, the subjects had other malignant tumors within the 5 years prior to enrollment. * There is central nervous system (CNS) metastasis, spinal cord compression, or meningeal metastasis. * There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage. * Prior systemic therapy with either TGF-β inhibitors or anti-angiogenic agents. * There is a history of non infectious pneumonia that requires systemic glucocorticoid treatment. * History of severe bleeding tendency or coagulation dysfunction. * Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia. * Pregnant or lactating female subject.
References
Publications (0)
Data not yet available
No reference posted for this study.