A Phase I Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IBR854 Cell Injection in Patients With Unresectable Locally Advanced Or Metastatic Solid Tumors

Imbioray (Hangzhou) Biomedicine Co., Ltd.1 site in 1 country18 target enrollmentSeptember 1, 2023

ConditionsSolid Tumors

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Solid Tumors
Sponsor: Imbioray (Hangzhou) Biomedicine Co., Ltd.
Enrollment: 18
Locations: 1
Primary Endpoint: Incidence of dose limiting toxicity (DLTs)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is an open-label, phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of IBR854 cell injection in patients with unresectable, locally advanced, or metastatic solid tumors.

Detailed Description

This study is a dose escalation study which adopts the 3+3 dose escalation design protocol. The dose is respectively 3.0×10\^9 cells, 5.0×10\^9 cells and 7.0×10\^9 cells. The administration is performed on day 1 and day 8 of each cycle (21 days). 3-6 subjects will be enrolled at every dose level. The first and second subjects in the same group shall be enrolled at an interval of at least 7 days, for the purpose of ensuring their safety. Only when the dose-limiting toxicity (DLT) of all subjects in the previous dose group was observed can the enrollment of the next dose group get started.

Registry

clinicaltrials.gov

Start Date

September 1, 2023

End Date

December 30, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Imbioray (Hangzhou) Biomedicine Co., Ltd.

Responsible Party

Principal Investigator

Ning Li

MD, PhD

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Eligibility Criteria

Inclusion Criteria

•Subjects volunteer to participate in this clinical study, are fully aware of the study and have signed the Informed Consent Form (ICF). Subjects are willing to follow and able to complete all trial procedures.
•Age: adult at the age of 18-75 (both inclusive), female or male.
•Subjects with histologically or cytologically confirmed, unresectable, locally advanced or metastatic solid tumors (which can be diagnosed with the use of tumor markers in combination with imaging for specific advanced tumors, such as liver cancer) who have no current standard of care.
•Eastern Cooperative Oncology Group (ECOG) score ≤2 and expected survival time \>3 months.
•According to the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 criteria, the subjects have at least one target lesion (non-lymph node lesion with major diameter ≥ 1.0cm or lymph node lesion with minor diameter ≥ 1.5 cm). A lesion that is within the field of previous radiotherapy could not be considered a target unless there is radiographic evidence of progression.
•Organ function during screening should meet the following criteria:
•Absolute neutrophil count (ANC) ≥1.5×10\^9/L; Platelet (PLT) ≥75×10\^9/L; Hemoglobin (Hb)≥80g/L (no blood transfusion or hematopoietic stimulator treatment within 7 days).
•Alanine aminotransferase (ALT)≤3×ULN (Patients with liver metastasis: ≤5×ULN); Aspartate aminotransferase (AST)≤3×ULN (Patients with liver metastasis: ≤5×ULN);
•Creatinine (Cr) ≤2× ULN; Creatinine clearance (Ccr) (to be calculated only when Cr \> 2× ULN) \> 50ml/min (Cockcroft-Gault formula);
•Activated partial thrombin time (APTT) ≤1.5×ULN, International normalized ratio (INR) ≤1.5×ULN (Patients with anticoagulants: ≤ 2.5×ULN).

Exclusion Criteria

•Have received systemic antitumor therapy within 4 weeks or five half-lives of the drug (whichever is longer) before the first dose of the study drug: Systemic chemotherapy (2 weeks for oral fluorouracil, 6 weeks for mitomycin C and nitrosoureas), endocrine therapy, targeted therapy (2 weeks or 5 half-life for small molecule targeted therapy, whichever is longer), immunotherapy, radical radiotherapy, tumor embolization, Chinese herbal medicine for anti-tumor indications, etc. Or received palliative radiotherapy within 2 weeks before the first dose.
•Toxic effects from previous antitumor therapy have not returned to grade 1 or less (other than alopecia or fatigue).
•Any prior adoptive cellular immunotherapy.
•Active brain metastases (one of the following criteria: clinical symptoms; A new diagnosis; Progression after previous local treatment).
•Have undergone major organ surgery within 4 weeks prior to their first use of the study drug, or required elective surgery during the study period.
•Long-term (≥ 3 days) treatment with a glucocorticoid (prednisone \> 10 mg per day or equivalent) or another immunosuppressive agent is anticipated to be required during the study. Inhaled or topical steroid hormones are allowed in subjects without active autoimmune disease
•Have received a live or attenuated vaccine within 4 weeks before the first dose or plan to receive a live or attenuated vaccine during the study period.
•Have severe infections that cannot be controlled.
•Active hepatitis B, hepatitis C virus infection or HIV infection.
•Have undergone an allogeneic bone marrow transplant or other organ transplant.