Actively Recruiting
KN 046 Plus Regorafenib in MSS Metastatic Colorectal Cancer
Led by Peking University Cancer Hospital & Institute · Updated on 2023-10-26
98
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 optimize immunotherapy strategies for microsatellite-stable colorectal cancer. We will include three types of metastatic colorectal cancer patients: those without liver metastasis, or carrying BRAF V600E mutation, or unable to tolerate chemotherapy as their initial or second-line treatment. The participants will receive a combination treatment of regorafenib and KN046 which is a PD-L1/CTLA-4 bispecific antibody. Treatment efficacy and safety profile would be evaluated in this study.
CONDITIONS
Official Title
KN 046 Plus Regorafenib in MSS Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign informed consent
- 18 years or older at consent with no gender restrictions
- Histologically confirmed colorectal adenocarcinoma, including signet ring cell and mucinous types
- At least one measurable or evaluable lesion at baseline per RECIST 1.1, not previously irradiated or showing progression after radiotherapy
- ECOG performance status 0 or 1
- Expected survival of at least 3 months
- Availability of archived or fresh tumor tissue samples
- Use of effective contraception for females of childbearing potential and male partners, with negative pregnancy test for females
- Willingness and ability to comply with study visits and procedures
- Good organ function within 7 days of dosing including specified blood counts, kidney and liver function, and coagulation parameters
- Meet treatment history criteria for respective cohorts: Cohort A with MSS mCRC without BRAF V600E and no active liver metastases; Cohort B with MSS mCRC with BRAF V600E mutation; Cohort C with MSS mCRC unsuitable or refusing standard chemotherapy
You will not qualify if you...
- Untreated active brain or meningeal metastases unless stable after treatment
- History of gastrointestinal perforation or fistula within 6 months unless healed
- Participation in other interventional trials or antitumor treatment within 28 days or 5 half-lives before dosing
- Major surgery within 28 days before dosing
- Use of systemic corticosteroids or immunosuppressants recently, with some exceptions
- Receipt of live vaccines within 28 days before dosing
- Interstitial lung disease or history of non-infectious pneumonia needing corticosteroids
- Active autoimmune disease requiring treatment within 2 years or risk of recurrence
- History of other cancers within 5 years except certain low-risk or cured cancers
- Uncontrolled comorbidities including active infections, heart conditions, or bleeding
- Unresolved toxicities from prior cancer treatments above grade 2 except specified exceptions
- History of allogeneic bone marrow or organ transplant
- Allergic or hypersensitivity reactions to antibody drugs
- Pregnancy or breastfeeding
- Any condition affecting safety or compliance as judged by investigator
- Prior treatment with immune checkpoint inhibitors or regorafenib
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
T
Ting Xu, MD
CONTACT
Z
zhenghang Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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