An Open-Label, Multi-Center, Phase I Study to Evaluate the Safety, Tolerability，Pharmacokinetic/Pharmacodynamics and Anti-tumor Activity of Tetra-specific Antibody GNC-035 in Participants With Relapsed/Refractory Hematologic Malignancy and Locally Advanced or Metastatic Solid Tumors

Sichuan Baili Pharmaceutical Co., Ltd.7 sites in 1 country33 target enrollmentFebruary 9, 2022

ConditionsHematologic Malignancies

InterventionsGNC-035

Overview

Phase: Phase 1
Intervention: GNC-035
Conditions: Hematologic Malignancies
Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Enrollment: 33
Locations: 7
Primary Endpoint: The recommended dose for future clinical study
Status: Active, not recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

In this study, the safety, tolerability and preliminary effectiveness of GNC-035 in patients with relapsed/refractory hematologic malignancies will be investigated to assess the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MAD) for MTD is not reached of GNC-035.

Registry

clinicaltrials.gov

Start Date

February 9, 2022

End Date

December 1, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The participants could understand and sign the informed consent form, and must participate voluntarily
•No gender limit
•Age: ≥18 and ≤75 years old
•Life expectancy estimated to be at least 3 months
•Histologically or cytologically confirmed relapsed or refractory non-Hodgkin's lymphoma, relapsed/refractory chronic lymphocytic leukemia, relapsed/refractory acute B-lymphoblastic leukemia, or relapsed/refractory acute myeloid leukemia
•For relapsed or refractory chronic lymphocytic leukemia (CLL/SLL), specifically:
•Patients who have relapsed after at least 1 line of standard therapy or who have failed or are intolerant to standard therapy;
•Patients with relapsed or refractory chronic lymphocytic leukemia who, in the opinion of the investigator, have none or are not suitable/intolerant to other therapies;
•For other patients with relapsed and refractory non-Hodgkin's lymphoma. These include:
•Patients in first relapse who still progress during second-line treatment;

Exclusion Criteria

•Patients who have undergone major surgery within 28 days prior to dosing in this study, or are scheduled to undergo major surgery during this study ("major surgery"is defined by the investigator)
•Pulmonary disease ≥ grade 3 according to NCI-CTCAEv5.0: including resting dyspnea, or requiring continuous oxygen therapy; patients with current interstitial lung disease (ILD) (except for those with previous interstitial pneumonia)
•Systemic serious infections occurred within 4 weeks before screening，including but not limited to severe pneumonia, bacteremia or serious infectious complications caused by fungi, bacteria and viruses
•Patients with active autoimmune diseases, or patients with a history of autoimmune diseases
•Patients complicated with other malignant tumors within 5 years before the first dose, and cured non-melanoma in situ skin cancer, superficial bladder cancer, in situ cervical cancer, gastrointestinal intramucosal cancer, breast cancer, localized prostate cancer and other cancers that are considered by the investigator to be eligible
•Positive human immunodeficiency virus antibody (HIVAb), active tuberculosis, active hepatitis B virus infection (positive HBsAg or positive HBcAb with HBV-DNA ≥ ULN), or hepatitis C virus infection (positive HCV antibody with HCV-RNA ≥ ULN)
•Hypertension poorly controlled on medication (systolic \> 150 mmHg or diastolic \> 100 mmHg)
•Left ventricular ejection fraction ≤ 45%, or history of significant cardiac disease within 1 year
•Patients with a history of hypersensitivity to recombinant humanized antibodies or hypersensitivity to any of the excipient components of GNC-035
•Women who are pregnant or breastfeeding

Arms & Interventions

study treatment

Patients receive GNC-035 as a 24-hour continuous intravenous infusion (cIV, QD) for 2 weeks (a 2-week cycle). Participants with no intolerable AEs could continue for another three cycles.

Intervention: GNC-035