A Phase I, Open-label, Dose Escalation Study to Evaluate the Safety ,tolerance and Pharmacokinetics of OH2 Via Transcatheter Intraarterial Infusion in Patients with Advanced Liver Cancer

Binhui Biopharmaceutical Co., Ltd.1 site in 1 country12 target enrollmentMay 5, 2023

ConditionsAdvanced Liver Cancer

InterventionsOH2 injection

DrugsOH2 injection

Overview

Phase: Phase 1
Intervention: OH2 injection
Conditions: Advanced Liver Cancer
Sponsor: Binhui Biopharmaceutical Co., Ltd.
Enrollment: 12
Locations: 1
Primary Endpoint: DLTs (Dose Limiting Toxicity)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

An open-label dose-escalation phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of OH2 injection via transcatheter Intraarterial infusion in patients with advanced hepatocellular carcinoma

Registry

clinicaltrials.gov

Start Date

May 5, 2023

End Date

January 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Binhui Biopharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have fully understood the study and voluntarily signed the informed consent (the informed consent must be signed before performing any procedure specified in the test);
•Age 18-75 years old (inclusive);
•Patients with primary or metastatic liver cancer confirmed histologically or cytologically;
•Patients with liver cancer who have failed standard treatment, are not suitable for or are not willing to accept standard treatment;
•ECOG physical condition 0 or 1;
•Meet Child-Pugh liver function rating: Grade A or B;
•Adequate bone marrow, liver, kidney and organ functions, meeting the following requirements in laboratory examination within 7 days prior to the first medication (no blood transfusion, blood products, no correction of granulocyte colony stimulating factor or other hematopoietic stimulating factors within 14 days prior to the laboratory examination) :
•Neutrophil absolute count (ANC) ≥1.5×109/L, platelet ≥100×109/L, hemoglobin ≥90g/L;
•Serum total bilirubin ≤3 times the upper limit of the normal reference range (3×ULN);
•Alanine transaminase (ALT) and/or aspartate transaminase (AST) ≤5×ULN;

Exclusion Criteria

•A history of pleural effusion related to moderate or severe ascites, hemorrhagic esophageal varices, hepatic encephalopathy, or liver insufficiency within 6 months prior to screening;
•Patients with large tumors - tumors \>50% by liver volume and/or invading inferior vena cava;
•Non-recovery to National Cancer Institute General Adverse Event Term 5.0 (NCI CTCAE V5.0) level 1 toxicity (excluding hair loss, non-clinically significant and asymptomatic laboratory abnormalities) due to prior antitumor therapy prior to initial administration of the study drug;
•Other malignancies (except basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix that have been effectively controlled) in the past 5 years;
•For subjects with known central nervous system metastases, if they have received BMS in the past and their condition is stable (no evidence of imaging progression is seen at least 4 weeks before the first administration of the trial therapy, and any neurological symptoms have returned to baseline), repeated imaging examinations confirm no evidence of new BMS or the expansion of the original BMS. Participants who do not require steroid therapy at least 14 days before the initial administration of the trial therapy are eligible to participate in the trial. Subjects with cancerous meningitis should be excluded regardless of whether they are clinically stable;
•Received standard anti-tumor therapy for liver cancer within 4 weeks before the first drug use, including surgery, interventional therapy, systemic therapy, radiotherapy and traditional Chinese medicine therapy (the instructions for traditional Chinese medicine therapy with clear anti-tumor indications, and a one-week washout period is enough before the first drug use);
•Received radical radiotherapy (including more than 25% bone marrow radiotherapy) within 4 weeks prior to initial medication;
•Have previously received similar drugs for antitumor therapy;
•Received major surgical operations (the definitions of major surgical operations refer to Grade 3 and Grade 4 operations specified in the "Measures for the Clinical Application of Medical Technology" implemented on May 1, 2009) or unhealed wounds, ulcers and fractures within 4 weeks before the first drug use;
•The subjects currently have active gastric and duodenal ulcers, ulcerative colitis and other digestive tract diseases, or active bleeding from unexcised tumors, or other conditions determined by the researchers that may cause digestive tract bleeding and perforation;

Arms & Interventions

OH2

Administration：intratumoral injection Frequency：once every 3 weeks

Intervention: OH2 injection

Outcomes

Primary Outcomes

DLTs (Dose Limiting Toxicity)

Time Frame: 3 weeks from the first administration

Toxic reactions according to the NCI-CTCAE 5.0 grading standard that occur within 3 weeks from the first administration, are judged to be drug-related by the investigator, and meet the non-hematological toxicity and hematological toxicity conditions specified in the clinical protocol

MTD (Maximum Tolerance dose)

Time Frame: 2 years

If ≥2/6 subjects developed DLT, the previous dose group was MTD