A Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer
ConditionPancreatic Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAkeso
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- AK112
- AK130
Treatment groups
160 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov