Advanced HCCPhase 1/2NCT05906524
KD6001 in Combination With Anti-PD-1 Antibody±Bevacizumab in Patients With Advanced HCC and Other Solid Tumors
A Phase 1/2 study testing KD6001, Tislelizumab and Bevacizumab in people with Advanced HCC and Other Solid Tumors, run by Shanghai Kanda Biotechnology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced HCC, Other Solid Tumors
- What is being tested?
- KD6001, Tislelizumab and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2024to 31 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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:
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital
Shanghai
Huichuan Sun, MD, 021-64041990, 674635898@qq.com
Jia Fan
About this study
Official title: 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
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
- Being tested
- KD6001, Tislelizumab, Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KD6001Drug
KD6001 will be administered intravenously.
TislelizumabDrug
Tislelizumab will be administered intravenously.
BevacizumabDrug
Bevacizumab will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| 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） Receives: Drug: KD6001; Drug: Tislelizumab |
| Phase 2：KD6001+Tislelizumab±Bevacizumab | Experimental | KD6001 combined with Tislelizumab±Bevacizumab in patients with advanced HCC Receives: Drug: KD6001; Drug: Tislelizumab; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Number of participants with response according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Measured: Baseline to study completion up to 2 years
Maximum Plasma Concentration [Cmax]
The PK profile of KD6001 in combination with Tislelizumab ± Bevacizumab.
Measured: 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.
Measured: Baseline to study completion up to 2 years
Half-life (T1/2)
The PK profile of KD6001 in combination with Tislelizumab ± Bevacizumab.
Measured: 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.
Measured: Baseline to study completion up to 2 years
Apparent volume of distribution (Vd)
The PK profile of KD6001 in combination with Tislelizumab ± Bevacizumab.
Measured: 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.
Measured: Baseline to study completion up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start15 Apr 2024 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced HCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Kanda Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05906524
- Sponsor's protocol ID
- KD6001CT03
- Status last verified
- May 2023
- First submitted
- 24 May 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05906524
- Acronym / sponsor ID
- KD6001CT03
- Conditions
- Advanced HCC, Other Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Shanghai Kanda Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1：KD6001+Tislelizumab | Experimental | Drug: KD6001, Drug: TislelizumabKD6001 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 | Drug: KD6001, Drug: Tislelizumab, Drug: BevacizumabKD6001 combined with Tislelizumab±Bevacizumab in patients with advanced HCC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KD6001KD6001 will be administered intravenously. | Drug | Phase 1：KD6001+Tislelizumab, Phase 2：KD6001+Tislelizumab±Bevacizumab |
| TislelizumabTislelizumab will be administered intravenously. | Drug | Phase 1：KD6001+Tislelizumab, Phase 2：KD6001+Tislelizumab±Bevacizumab |
| BevacizumabBevacizumab will be administered intravenously. | Drug | Phase 2：KD6001+Tislelizumab±Bevacizumab |
Primary outcome
Number of Participants with Dose Limiting Toxicities (DLTs)
Time frame: Up to Day 21
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.
The incidence and safety profile of participants with adverse events (AEs), serious adverse events(SAE), and immune-related adverse event(irAE)
Time frame: Baseline to study completion up to 2 years
Evaluate the adverse events (AE) according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 (NCI CTCAE 5.0).
7 secondary outcomes
The antitumor activity of KD6001 in combination with Tislelizumab ± Bevacizumab measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: Baseline to study completion up to 2 years
Maximum Plasma Concentration [Cmax]
Time frame: Baseline to study completion up to 2 years
Time to reach maximum serum concentration (Tmax)
Time frame: Baseline to study completion up to 2 years
Half-life (T1/2)
Time frame: Baseline to study completion up to 2 years
Area under blood concentration-time curve(AUC0-T and AUC0-∞)
Time frame: Baseline to study completion up to 2 years
Apparent volume of distribution (Vd)
Time frame: Baseline to study completion up to 2 years
The immunogenicity of KD6001 in combination with Tislelizumab ± Bevacizumab
Time frame: Baseline to study completion up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
Related trials for Advanced HCC
RecruitingPhase 2
SBRT With Immunotherapy and Atezo-Bev in HCC With Major Portal Vein Thrombosis
HCC
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Not yet recruitingPhase 2
A Clinical Study Evaluating the Safety and Efficacy of Ivonescimab as Second-line Treatment in Patients With Advanced Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC), HCC - Hepatocellular Carcinoma
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Active, not recruitingPhase 1
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors
Locally Advanced or Metastatic Solid Tumors, NSCLC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing KD6001, Tislelizumab and Bevacizumab in people with Advanced HCC and Other Solid Tumors, run by Shanghai Kanda Biotechnology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chi Zhang (+8615800854907, zhangchi@kandatech.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Dose Limiting Toxicities (DLTs) (time frame: Up to Day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.