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KD6001 in Combination With Anti-PD-1 Antibody±Bevacizumab in Patients With Advanced HCC and Other Solid Tumors | Clinical Trials | Clareo Health

UNKNOWNPHASE1/PHASE2

KD6001 in Combination With Anti-PD-1 Antibody±Bevacizumab in Patients With Advanced HCC and Other Solid Tumors

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of KD6001 in Combination With Tislelizumab±Bevacizumab in Patients With Advanced HCC and Other Solid Tumors

NCT05906524•Shanghai Kanda Biotechnology Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.
+4 more criteria

Locations (1)

Zhongshan Hospital

Shanghai, China

Key Dates

Start Date

April 15, 2024

Primary Completion Date

April 30, 2025

Completion Date

December 31, 2025

Last Updated

January 10, 2024

Enrollment

ESTIMATED participants

Conditions

Advanced HCCOther Solid Tumors

Interventions

KD6001

DRUG

Tislelizumab

DRUG

Bevacizumab

DRUG

Contacts

Chi Zhang

CONTACT

+8615800854907 zhangchi@kandatech.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 10, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

KD6001 in Combination With Anti-PD-1 Antibody±Bevacizumab in Patients With Advanced HCC and Other Solid Tumors

Inclusion Criteria

Exclusion Criteria

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