A Multi-center, Open Phase Ia/Ib Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Preliminary Clinical Efficacy of BAT7104 Injection in Patients With Advanced Malignant Tumors.

Bio-Thera Solutions1 site in 1 country86 target enrollmentJanuary 20, 2022

ConditionsAdvanced Malignant Tumor

InterventionsBAT7104 injection

DrugsBAT7104 injection

Overview

Phase: Phase 1
Intervention: BAT7104 injection
Conditions: Advanced Malignant Tumor
Sponsor: Bio-Thera Solutions
Enrollment: 86
Locations: 1
Primary Endpoint: Adverse Events (AEs)
Status: Completed
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A multi-center, open phase Ia/Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and preliminary clinical efficacy of BAT7104 injection in patients with advanced malignant tumors.

Detailed Description

This is a multi-center, open, dose-increased and dose-expanded phase I clinical study. About 18-42 patients will be recruited from research centers in China. In the stage of dose increase, the safety, tolerance, pharmacokinetics and preliminary clinical efficacy of BAT7104 injection in patients with advanced malignant tumors were investigated by using accelerated titration and "3+3" dose increase design. During the dose increase test, the appropriate dose was selected according to the previous study data of the extended study.

Registry

clinicaltrials.gov

Start Date

January 20, 2022

End Date

December 11, 2024

Last Updated

5 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Bio-Thera Solutions

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age: ≥ 18 years old and ≤ 80 years old, gender: male or female;
•The investigator evaluated the expected survival period to be at least 3 months;
•The requirement of the ECOG physical fitness score is 0 or 1;
•Patients with advanced malignant tumors who have failed to receive standard treatment, have no standard treatment, do not tolerate standard treatment or refuse to accept standard treatment confirmed by cytology or pathology;
•There must be an evaluable tumor focus in the dose increasing stage, and at least one measurable tumor focus in the dose expanding stage (solid tumors refer to RECIST 1.1 standard, lymphoma refer to Lugano 2014 evaluation standard);
•It has sufficient organ and bone marrow reserve function, which is defined as follows:
•System laboratory reference value:
•Blood routine (no blood transfusion, no use of hematopoietic stimulating factor and no use of drugs to correct blood cell count within 14 days before the first administration):
•Absolute neutrophil count ≥ 1.5 x 109/L;Platelet count ≥ 90 x109/L;Hemoglobin ≥ 90g/L;
•Coagulation function:

Exclusion Criteria

•Have received any anti-CD47 antibody and SIRP within 4 weeks before the first administration α Antibodies or CD47/SIRP α Recombinant protein therapy;
•He has received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatment within 4 weeks before the first use of the study drug, with the exception of the following: ① nitrosourea or mitomycin C within 6 weeks before the first use of the study drug; ② Oral fluorouracil and small-molecule targeted drugs are 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever is longer); ③ The systematic treatment of traditional Chinese medicine/proprietary Chinese medicine with clear anti-tumor effect and drugs with immunomodulatory effect (including but not limited to thymosin, interferon, interleukin, etc.) is within 2 weeks before the first use of the study drug;
•Those who are participating in or have participated in the experimental drug or medical device intervention clinical research within 4 weeks before the first administration of this study cannot be included; In the survival follow-up stage of the intervention study, if the time between the first administration and the end of the previous study (the last administration) meets the above exclusion criteria, it can be included;
•Inoculated or planned to receive live/attenuated vaccine and mRNA vaccine within 4 weeks before screening;
•Pregnant or lactating women;
•AEs caused by previous anti-tumor therapy are still higher than grade 1 (based on CTCAE v5.0) before the first administration of the study drug (except for AEs such as hair loss and fatigue that cannot be restored to ≤ grade 1 and will remain stable for a long time according to the judgment of the researcher based on clinical actual conditions, except for grade 2 peripheral neurotoxicity, and hypothyroidism stabilized by hormone replacement therapy);
•Those who have had ≥ 3 levels of irAE in the past or have terminated immunotherapy due to any level of irAE;
•Primary central nervous system tumor, central nervous system metastasis with related symptoms, meningeal metastasis or previous history of epilepsy should be excluded. Patients with asymptomatic or asymptomatic central nervous system metastasis who have been clinically controlled but have been judged stable by the researcher can be included, but the following conditions must be met at the same time: a The disease was stable ≥ 4 weeks before the first administration; B. No evidence of central nervous system disease progression was found in MRI enhancement of the head within 4 weeks before the first administration; C. The anticonvulsant drugs have been stopped at least 2 weeks before the first administration, and the dosage of prednisone is ≤ 10mg/day or equivalent dose of hormone;
•Patients who have undergone major organ surgery (excluding puncture biopsy) or had significant trauma within 4 weeks before the first use of the study drug, or who need to undergo elective surgery during the trial period;
•Have a history of tissue or organ transplantation;