A Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer
Recruiting
Phase 2Interventional Study
Pancreatic Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
160 (estimated)
Sponsor
Akeso · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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 du…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.