A Phase I Study To Evaluate The Safety, Tolerability and Pharmacokinetics Of BH009 In Patients With Advanced Head And Neck Squamous (Non-nasopharyngeal) And Ovarian Cancer

Zhuhai Beihai Biotech Co., Ltd5 sites in 1 country24 target enrollmentJanuary 18, 2023

ConditionsSolid Tumor, Adult

InterventionsBH009

DrugsBH009

Overview

Phase: Phase 1
Intervention: BH009
Conditions: Solid Tumor, Adult
Sponsor: Zhuhai Beihai Biotech Co., Ltd
Enrollment: 24
Locations: 5
Primary Endpoint: MTD of BH009
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will assess the safety and tolerability and pharmacokinetics of BH009 in patients with advanced head and neck squamous (non-nasopharyngeal) and ovarian cancer.

Detailed Description

This is a multicenter, open label phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic profile of BH009 in patients with advanced squamous head and neck cancer (non-nasopharyngeal) and ovarian cancer, and to initially explore its clinical effectiveness. This study will use a "3+3" dose escalation design to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of BH009.

Registry

clinicaltrials.gov

Start Date

January 18, 2023

End Date

April 30, 2024

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

•Male or female subjects aged between 18-70 years old at the time of informed consent.
•Histologically or cytologically proven squamous cell carcinoma of the head and neck(including oropharynx, oral cavity, hypopharynx and larynx, excluding nasopharyngeal carcinoma) and ovarian carcinoma (including epithelial ovarian carcinoma, fallopian tube carcinoma and primary peritoneal carcinoma).
•Subjects who failed by standard treatments, or refused standard treatments, or the investigator considered the subject unsuitable for standard treatments.
•At least one measurable lesion according to RECIST 1.1 at baseline.
•Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
•Subjects must have an expected survival of at least 3 months.
•Subjects must have adequate organ and marrow function. Laboratory results meet the following conditions within 7 days prior to the first dose \[subjects must not have received recombinant granulocyte-colony stimulating factor (G-CSF) or blood transfusion within 14 days prior to the first dose\]:
•Hematological : Absolute neutrophil count(ANC)≥1.5×109/L, platelet count(PLT)≥100×109/L, hemoglobin(Hb)≥90 g/L;
•Renal function :Serum creatinine(Cr)≤1.5×ULN and creatinine Clearance ≥50 mL/min(Cockcroft-Gault );
•Liver function : Total bilirubin ≤1.5×ULN, alanine aminotransferase(ALT)and aspartate aminotransferase(AST) ≤ 1.5×ULN (if liver tumor/metastases are present, then ≤2.5×ULN is allowed).

Exclusion Criteria

•Subjects with a known hypersensitivity to the study drug and any excipient contained in the drug formulation,or intolerance to paclitaxel analogues.
•Subjects are currently receiving other anti-tumor therapy.
•Subjects requiring a potent inhibitor of CYP3A4 within 14 days prior to the first dose and during the study period.
•Subjects have been treated with systemically administered glucocorticosteroid (prednisone \> 10 mg/day or equivalent dose of other similar drug) or other immunosuppressive agents within 14 days prior to the first use of the investigational medicinal product; with the exception of the following: treatment with topical, ophthalmic, intra-articular, intranasal, and inhaled glucocorticosteroids; and short-term prophylactic glucocorticosteroids (e.g., prevention of allergy to contrast media).
•Subjects with clinically significant psychiatric or central nervous system disorders.
•Subjects with a primary malignant tumour of the brain; or those who with two or more malignant tumours (except cured non-melanoma skin cancer, cervical cancer, thyroid cancer and intramucosal cancer of the gastrointestinal tract).
•Subjects who with serious medical conditions:
•Subjects with clinically significant cardiovascular disease, including: severe or uncontrolled heart disease requiring treatment, congestive heart failure classified by the New York Heart Association (NYHA) as grade 3 or 4, unstable angina pectoris uncontrolled by medication, history of myocardial infarction within 6 months prior to enrolment, severe arrhythmia requiring medication (except atrial fibrillation or paroxysmal supraventricular tachycardia);
•Subjects with indwelling cardiac stents within 6 months;
•Subjects with uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg after pharmacological intervention), diabetes mellitus (glycated haemoglobin HbA1c ≥8.0% or fasting blood glucose ≥10.0 mmol/L), pleural effusion, pericardial effusion, ascites;

Arms & Interventions

BH009

Every 28 days constitutes a treatment cycle, and administration on day 1, day 8, day 15 of each cycle

Intervention: BH009

Outcomes

Primary Outcomes

MTD of BH009

Time Frame: first dose to 30 days after last dose

When the dose is incremented beyond the MTD, the previous lower dose group will be identified as the MTD.

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Time Frame: first dose to 30 days after last dose

All adverse events (AE) defined by CTCAE version 5.0

Recommended phase 2 dose of BH009

Time Frame: first dose to 30 days after last dose

defined by CTCAE version 5.0

Secondary Outcomes

Progression-free survival(After first dose until 30 days after last dose)
PK Analysis of BH009(predose, 30 minutes, 45 minutes, 1 hour after the start of infusion (immediately after the end of infusion), 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours after the end of infusion)
Duration of relief(After first dose until 30 days after last dose)
Disease control rate(After first dose until 30 days after last dose)
Objective response rate(After first dose until 30 days after last dose)