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

NCT05906524 | Unknown Phase 1

• 1 other identifier: KD6001CT03
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced HCC; Other Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Dose Limiting Toxicities (DLTs)

  DLTs will be assessed during the dose-escalation phase and are defined as the following treatment-related adverse events occurring within a total of 21 days after the first trial administration.

  Up to Day 21

• The incidence and safety profile of participants with adverse events (AEs), serious adverse events(SAE), and immune-related adverse event(irAE)

  Evaluate the adverse events (AE) according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 (NCI CTCAE 5.0).

  Baseline to study completion up to 2 years

Secondary Outcomes (7)

• The antitumor activity of KD6001 in combination with Tislelizumab ± Bevacizumab measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

  Baseline to study completion up to 2 years

• Maximum Plasma Concentration [Cmax]

  Baseline to study completion up to 2 years

• Time to reach maximum serum concentration (Tmax)

  Baseline to study completion up to 2 years

• Half-life (T1/2)

  Baseline to study completion up to 2 years

• Area under blood concentration-time curve(AUC0-T and AUC0-∞)

  Baseline to study completion up to 2 years

Study Arms (2)

Phase 1：KD6001+Tislelizumab

EXPERIMENTAL

KD6001 combined with Tislelizumab in patients with solid tumors（hepatocellular carcinoma, esophageal squamous cell carcinoma, MSI-H or dMMR solid tumors are preferentially included）

Drug: KD6001; Drug: Tislelizumab

Phase 2：KD6001+Tislelizumab±Bevacizumab

EXPERIMENTAL

KD6001 combined with Tislelizumab±Bevacizumab in patients with advanced HCC

Drug: KD6001; Drug: Tislelizumab; Drug: Bevacizumab

Interventions

KD6001 DRUG

KD6001 will be administered intravenously.

Phase 1：KD6001+Tislelizumab; Phase 2：KD6001+Tislelizumab±Bevacizumab

Tislelizumab DRUG

Tislelizumab will be administered intravenously.

Phase 1：KD6001+Tislelizumab; Phase 2：KD6001+Tislelizumab±Bevacizumab

Bevacizumab DRUG

Bevacizumab will be administered intravenously.

Phase 2：KD6001+Tislelizumab±Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being voluntary to sign the informed consent form.
• Male or female, aged ≥ 18 years.
• Patients whose estimated survival time is more than 3 months.
• Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1.
• 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).
• 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.
• Patients will agree to provide tumor tissue samples.
• The results of laboratory examination during the screening period suggest that the subjects have good organ function.
• Male subjects with reproductive ability or female subjects with the possibility of pregnancy use effective contraceptive methods.
• Good compliance and follow-up.

You may not qualify if:

• 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.
• Systematic treatment with antitumor drugs within 4 weeks prior to the start of this study.
• Prior treatment with anti-CTLA-4 antibody.
• Adverse events caused by prior treatment did not recovered to NCI-CTCAE v5.0 grade 1 and below.
• Subjects with CNS metastases or leptomeningeal disease.
• Subjects with an active, known or suspected autoimmune disease.
• Subjects with acute or chronic active hepatitis B or hepatitis C.
• Has histological or cytological diagnosis of fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma.
• Subjects suffers from severe cardiovascular and cerebrovascular diseases. History or evidence of bleeding diathesis or significant coagulopathy at risk of bleeding.
• Subjects with an active infection requiring systemic treatment.
• Known history of testing positive for human immunodeficiency virus (HIV).
• Subjects known to have active tuberculosis (TB).
• Pregnant or breastfeeding females.
• Known to be allergic to KD6001, tislelizumab, bevacizumab or its components.

Sponsors & Collaborators

• Shanghai Kanda Biotechnology Co., Ltd.: lead

Study Sites (1)

Zhongshan Hospital

Shanghai, China

Location

MeSH Terms

Interventions

tislelizumab; Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Chi Zhang

CONTACT

+8615800854907; zhangchi@kandatech.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 18, 2023
• Study Start: April 15, 2024
• Primary Completion: April 30, 2025
• Study Completion: December 31, 2025
• Last Updated: January 10, 2024

Record last verified: 2023-05

Locations

CN (1)