Phase I Clinical Trial of Safety, Tolerability and Pharmacokinetics of BH002 in Patients With Advanced Solid Tumors

Zhuhai Beihai Biotech Co., Ltd2 sites in 1 country12 target enrollmentApril 26, 2022

ConditionsSolid Tumours

InterventionsBH002

DrugsBH002

Overview

Phase: Phase 1
Intervention: BH002
Conditions: Solid Tumours
Sponsor: Zhuhai Beihai Biotech Co., Ltd
Enrollment: 12
Locations: 2
Primary Endpoint: Obtain the pharmacokinetic characteristics of BH002 in Chinese patients with advanced solid tumors.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to about in Patients With Advanced Solid Tumors. The main question[s] it aims to answer are:

question 1:Evaluating the tolerability of BH002 injection in Chinese patients with advanced solid tumors
question 2:Obtain the pharmacokinetic (PK) characteristics of BH002 injection in Chinese patients with advanced solid tumors

Detailed Description

Subjects will be administered BH002 intravenously. It is expected that there will be 2 to 4 dose groups, with 3 to 6 subjects enrolled in each group. The doses from low to high are 15 mg/m2,20 mg/m2,25 mg/m2,30 mg/m2,35 mg/m2. Subjects were injected with BH002 intravenously on the first day of each cycle, once during a 3-week period. The dose escalation for this trial will be 20mg/m2 as the starting dose. According to the traditional "3+3" dose escalation principle, 3 subjects are planned to be enrolled in each dose group at the same time. Safety, tolerability, and dose-limiting toxicities (DLTs) will be assessed within 21 days of first dose.

Registry

clinicaltrials.gov

Start Date

April 26, 2022

End Date

March 31, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Zhuhai Beihai Biotech Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years old, male or female.
•Patients were diagnosed advanced solid tumors by histology or cytology (preferably prostate cancer, gastric cancer, non-small cell lung cancer, breast cancer, esophageal cancer, head and neck squamous cell carcinoma, ovarian cancer, liposarcoma, etc.) whose disease progresses after standard treatment.
•ECOG score 0\~2, expected survival time ≥3 months.
•Have adequate hematology and organ function, and meet the following conditions based on laboratory test results within 7 days before the first dose:1)For those who have not received blood transfusions, blood products or blood cytokines such as granulocyte colony-stimulating factor (G-CSF) within 14 days of the first dose, blood routine: neutrophil count ≥2.0×109/L, platelet count ≥100×109 /L, white blood cell count ≥4.0×109/L, hemoglobin concentration ≥8.0g/dL. 2)Blood biochemistry: liver function: aspartate aminotransferase and alanine aminotransferase ≤1.5 times the upper limit of normal (ULN), total bilirubin ≤ULN. kidney function: creatinine ≤1.5×ULN.
•Baseline left ventricular ejection fraction determined by echocardiography ≥50%, normal or abnormal 12-lead electrocardiogram without clinical significance, QTc interval \<450ms (men) or \<470ms (women), and no symptoms or signs of heart failure.
•The functions of major organs (heart, lung, liver, kidney, bone marrow, gastrointestinal) are basically normal or abnormal without clinical significance, and acute toxicity caused by previous treatment is relieved to ≤ grade 1 (except for hair loss).
•If the subject has been previously treated with surgery, chemotherapy, immunotherapy, biologic therapy, targeted therapy, anti-tumor traditional Chinese medicine, or small molecule targeted drug, the first dose should be given at an interval of 4 weeks or more than 5 half-lives (whichever is shorter)；If the chemotherapeutic agent is mitomycin or nitrosourea, the first dose needs to be given more than 6 weeks apart.
•The first dose was more than 6 weeks after the last radiotherapy (except palliative radiotherapy for local pain control), and there was no previous whole-pelvic radiotherapy (radiotherapy ≤30% of the bone marrow area).
•With the consent of the individual and an informed consent form signed by the individual or his legal representative.
•The subject can communicate well with the researcher and complete the research in accordance with the research regulations.

Exclusion Criteria

Not provided

Arms & Interventions

BH002

Every 21 days constitutes a treatment cycle, and administration begins on the first day of each cycle

Intervention: BH002

Outcomes

Primary Outcomes

Obtain the pharmacokinetic characteristics of BH002 in Chinese patients with advanced solid tumors.

Time Frame: 216 hours after first dose

Maximum Plasma Concentration \[Cmax\], etc,

Evaluating the tolerability of BH002 in Chinese patients with advanced solid tumors.

Time Frame: 21 days after first dose

maximum tolerated dose \[MTD\]

Secondary Outcomes

To evaluate the safety of BH002 in Chinese patients with advanced solid tumors.(From first dose to 30 days after last dose)
Evaluating the preliminary anti-tumor activity of BH002 in Chinese patients with advanced solid tumors(From first dose to 30 days after last dose)
Determination of recommended phase Ⅱ dose (RP2D)(21 days after first dose)