KD6001 in Combination With Anti-PD-1 Antibody±Bevacizumab in Patients With Advanced HCC and Other Solid Tumors
NCT ID: NCT05906524
Last Updated: 2024-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE1/PHASE2
85 participants
INTERVENTIONAL
2024-04-15
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Anti-PD-1/PD-L1 Antibodies Plus Anti-VEGF Antibody Treatment in Patients With Advanced-Stage HCC
NCT06537908
Candonilimab Plus Bevacizumab for Patients With Advanced HCC Who Progressed on A+T
NCT05760599
Combination of Cardonizumab Injection and TKI Second Line Therapy for Advanced Hepatocellular Cancer
NCT06363006
Lenvatinib Plus Tislelizumab Versus Lenvatinib Alone in Hepatocellular Carcinoma Previously Treated With Anti-PD1/PD-L1 and Bevacizumab
NCT07047586
ICIs and Anti-VEGF Antibody/TKIs With or Without Interventional Therapy for Advanced HCC
NCT07157969
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Phase 1：KD6001+Tislelizumab
KD6001 combined with Tislelizumab in patients with solid tumors（hepatocellular carcinoma, esophageal squamous cell carcinoma, MSI-H or dMMR solid tumors are preferentially included）
KD6001
KD6001 will be administered intravenously.
Tislelizumab
Tislelizumab will be administered intravenously.
Phase 2：KD6001+Tislelizumab±Bevacizumab
KD6001 combined with Tislelizumab±Bevacizumab in patients with advanced HCC
KD6001
KD6001 will be administered intravenously.
Tislelizumab
Tislelizumab will be administered intravenously.
Bevacizumab
Bevacizumab will be administered intravenously.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
KD6001
KD6001 will be administered intravenously.
Tislelizumab
Tislelizumab will be administered intravenously.
Bevacizumab
Bevacizumab will be administered intravenously.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Male or female, aged ≥ 18 years.
3. Patients whose estimated survival time is more than 3 months.
4. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1.
5. At least one measurable lesion is used as the target lesion according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST V1.1).
6. Histologically or cytologically confirmed advanced solid tumors. Have a current liver function meeting Child Pugh Class A in patients with HCC.
Part A: Advanced solid tumors. PartB/C: HCC.
7. Patients will agree to provide tumor tissue samples.
8. The results of laboratory examination during the screening period suggest that the subjects have good organ function.
9. Male subjects with reproductive ability or female subjects with the possibility of pregnancy use effective contraceptive methods.
10. Good compliance and follow-up.
Exclusion Criteria
2. Systematic treatment with antitumor drugs within 4 weeks prior to the start of this study.
3. Prior treatment with anti-CTLA-4 antibody.
4. Adverse events caused by prior treatment did not recovered to NCI-CTCAE v5.0 grade 1 and below.
5. Subjects with CNS metastases or leptomeningeal disease.
6. Subjects with an active, known or suspected autoimmune disease.
7. Subjects with acute or chronic active hepatitis B or hepatitis C.
8. Has histological or cytological diagnosis of fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma.
9. Subjects suffers from severe cardiovascular and cerebrovascular diseases. History or evidence of bleeding diathesis or significant coagulopathy at risk of bleeding.
10. Subjects with an active infection requiring systemic treatment.
11. Known history of testing positive for human immunodeficiency virus (HIV).
12. Subjects known to have active tuberculosis (TB).
13. Pregnant or breastfeeding females.
14. Known to be allergic to KD6001, tislelizumab, bevacizumab or its components.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Kanda Biotechnology Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zhongshan Hospital
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
KD6001CT03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.