Clinical trial NCT05906524: KD6001 in Combination With Anti-PD-1 Antibody±Bevacizumab in Patients With Advanced HCC and Other Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced HCC
Other Solid Tumors
Lead sponsor: Shanghai Kanda Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants with Dose Limiting Toxicities (DLTs)
timeFrame: Up to Day 21
measure: The incidence and safety profile of participants with adverse events (AEs), serious adverse events(SAE), and immune-related adverse event(irAE)
timeFrame: Baseline to study completion up to 2 years
Secondary outcomes:
measure: The antitumor activity of KD6001 in combination with Tislelizumab ± Bevacizumab measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
timeFrame: Baseline to study completion up to 2 years
measure: Maximum Plasma Concentration [Cmax]
timeFrame: Baseline to study completion up to 2 years
measure: Time to reach maximum serum concentration (Tmax)
timeFrame: Baseline to study completion up to 2 years
measure: Half-life (T1/2)
timeFrame: Baseline to study completion up to 2 years
measure: Area under blood concentration-time curve(AUC0-T and AUC0-∞)
timeFrame: Baseline to study completion up to 2 years
measure: Apparent volume of distribution (Vd)
timeFrame: Baseline to study completion up to 2 years
measure: The immunogenicity of KD6001 in combination with Tislelizumab ± Bevacizumab
timeFrame: Baseline to study completion up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
Study officials:
References: