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Trial Title:
KD6001 in Combination With Anti-PD-1 Antibody±Bevacizumab in Patients With Advanced HCC and Other Solid Tumors
NCT ID:
NCT05906524
Condition:
Advanced HCC
Other Solid Tumors
Conditions: Official terms:
Neoplasms
Bevacizumab
Tislelizumab
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
KD6001
Description:
KD6001 will be administered intravenously.
Arm group label:
Phase 1：KD6001+Tislelizumab
Arm group label:
Phase 2：KD6001+Tislelizumab±Bevacizumab
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Tislelizumab will be administered intravenously.
Arm group label:
Phase 1：KD6001+Tislelizumab
Arm group label:
Phase 2：KD6001+Tislelizumab±Bevacizumab
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
Bevacizumab will be administered intravenously.
Arm group label:
Phase 2：KD6001+Tislelizumab±Bevacizumab
Summary:
This is a phase 1b/2, open label study to evaluate the safety, tolerability,
pharmacokinetics and initial efficacy of KD6001 in combination with Tislelizumab ±
Bevacizumab in patients with Advanced HCC and Other Solid Tumors.
Criteria for eligibility:
Criteria:
Main Inclusion Criteria:
1. Being voluntary to sign the informed consent form.
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.
Main Exclusion Criteria:
1. History of malignancy other than the disease under study within 5 years prior to
screening，except those malignancies that are expected to be cured after treatment.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongshan Hospital
Address:
City:
Shanghai
Country:
China
Contact:
Last name:
Huichuan Sun, MD
Phone:
021-64041990
Email:
674635898@qq.com
Investigator:
Last name:
Jia Fan
Email:
Principal Investigator
Investigator:
Last name:
Tianshu Liu
Email:
Principal Investigator
Start date:
April 15, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Shanghai Kanda Biotechnology Co., Ltd.
Agency class:
Industry
Source:
Shanghai Kanda Biotechnology Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05906524
