Actively Recruiting
KN046 Plus Regorafenib or Apatinib in MSI-H Digestive System Cancers Resistant to PD-1/PD-L1 Blockade
Led by Peking University Cancer Hospital & Institute · Updated on 2023-10-26
39
Participants Needed
1
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is an interventional phase II clinical trial aiming to evaluate the efficacy and safety of KN046, a PD-L1 and CTLA-4 bispecific antibody, in combination with regorafenib or apatinib for microsatellite instability-high digestive system cancers resistant to PD-1/PD-L1 blockade. KN046 plus regorafenib will be given for patients with colorectal cancers, and KN046 plus apatinib will be given for patients with gastric cancers (including esophageal-gastric junction cancers) and other kinds of digestive system cancers.
CONDITIONS
Official Title
KN046 Plus Regorafenib or Apatinib in MSI-H Digestive System Cancers Resistant to PD-1/PD-L1 Blockade
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign informed consent
- Age 18 years or older at consent, any gender
- Histologically confirmed digestive system cancers
- At least one measurable or evaluable lesion per RECIST 1.1; if only one lesion, it must not be previously radiated or must show progression after radiotherapy
- ECOG performance status 0 or 1
- Expected survival of 3 months or more
- Availability of archived or fresh tumor tissue samples
- Use of highly effective contraception for females of childbearing potential and males with partners of childbearing potential, with negative pregnancy test for females within 7 days before first dose
- Ability and willingness to comply with study procedures and visits
- Good organ function within 7 days of initial dosing, including specified blood counts and liver/kidney function
- Diagnosed with dMMR/MSI-H cancers resistant to PD-1/PD-L1 blockade, confirmed by PCR or NGS
You will not qualify if you...
- Untreated active brain or meningeal metastases; stable treated brain metastases allowed
- History of gastrointestinal perforation or fistula within 6 months unless resolved or improved
- Received other antitumor treatments or interventional trials within 28 days or 5 half-lives prior to dosing, except palliative bone radiotherapy
- Major surgery within 28 days before first dose (excluding minor procedures)
- Need for systemic corticosteroids (≥10 mg prednisone or equivalent) or immunosuppressives for 7 continuous days within 14 days prior to dosing; exceptions apply
- Received live vaccines within 28 days before dosing
- Interstitial lung disease or history of non-infectious pneumonia requiring corticosteroids
- Active autoimmune diseases needing systemic treatment within 2 years or at risk of recurrence
- History of other malignancies within 5 years, with specified exceptions
- Uncontrolled comorbidities including active HBV/HCV infection outside defined limits, HIV/AIDS, active tuberculosis, active infection requiring anti-infective drugs for over 1 week within 28 days, recent fever of unknown cause, uncontrolled cardiovascular conditions, or active bleeding
- Unresolved toxicity from prior treatments above grade 2 except certain conditions
- History of allogeneic bone marrow or organ transplant
- Previous severe allergic or hypersensitivity reactions to antibody drugs
- Pregnant or breastfeeding females
- Other conditions affecting safety or compliance such as moderate to large pleural/ascites/pericardial effusions, intestinal obstruction, psychiatric disorders
- Prior treatment with immune checkpoint inhibitors combined with anti-VEGF tyrosine kinase inhibitors including regorafenib and apatinib
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
Z
Zhenghang Wang
CONTACT
T
Ting Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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