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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Phase 2:KD6001+Tislelizumab±Bevacizumab | Experimental | KD6001 combined with Tislelizumab±Bevacizumab in patients with advanced HCC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KD6001 | Drug | KD6001 will be administered intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The antitumor activity of KD6001 in combination with Tislelizumab ± Bevacizumab measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 | Number of participants with response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. | Baseline to study completion up to 2 years |
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Main Inclusion Criteria:
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.
Main Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chi Zhang | Contact | +8615800854907 | zhangchi@kandatech.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Shanghai | China |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Tislelizumab | Drug | Tislelizumab will be administered intravenously. |
|
| Bevacizumab | Drug | Bevacizumab will be administered intravenously. |
|
| Maximum Plasma Concentration [Cmax] |
The PK profile of KD6001 in combination with Tislelizumab ± Bevacizumab. |
| Baseline to study completion up to 2 years |
| Time to reach maximum serum concentration (Tmax) | The PK profile of KD6001 in combination with Tislelizumab ± Bevacizumab. | Baseline to study completion up to 2 years |
| Half-life (T1/2) | The PK profile of KD6001 in combination with Tislelizumab ± Bevacizumab. | Baseline to study completion up to 2 years |
| Area under blood concentration-time curve(AUC0-T and AUC0-∞) | The PK profile of KD6001 in combination with Tislelizumab ± Bevacizumab. | Baseline to study completion up to 2 years |
| Apparent volume of distribution (Vd) | The PK profile of KD6001 in combination with Tislelizumab ± Bevacizumab. | Baseline to study completion up to 2 years |
| The immunogenicity of KD6001 in combination with Tislelizumab ± Bevacizumab | Including the incidence of ADA positive. For ADA positive patients, the incidence of neutralizing antibody (Nab) will be analyzed. | Baseline to study completion up to 2 years |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |