An Open-Label, Multi-Center, Phase I Study I Study to Evaluate the Safety, Tolerability, Pharmacokinetic/Phamacodynamics and Anti-tumor Activity of Tetra-specific Antibody GNC-035 in Participants With Locally Advanced or Metastatic Breast Cancer

Sichuan Baili Pharmaceutical Co., Ltd.6 sites in 1 country36 target enrollmentNovember 26, 2021

ConditionsBreast Cancer

InterventionsGNC-035

DrugsGNC-035

Overview

Phase: Phase 1
Intervention: GNC-035
Conditions: Breast Cancer
Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Enrollment: 36
Locations: 6
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 participants with locally advanced or metastatic Breast Cancer 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

November 26, 2021

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 years old
•Histologically or cytologically documented, locally advanced or metastatic breast cancer,and disease progression confirmed by imaging or other objective evidence after having received standard treatment; or patients with refractory breast cancer who cannot tolerate standard treatment or have contraindications to standard treatment
•Measurable disease at baseline as assessed by the Investigator per RECIST v1.1
•ECOG Performance Status ≤ 1
•Life expectancy estimated to be at least 3 months
•Acceptable bone marrow function： Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L, and hemoglobin ≥ 90 g/L.
•Acceptable renal function:
•Creatinine (Cr) ≤ 1.5ULN or creatinine clearance (Ccr) ≥ 50 mL/min (calculated by the study site), urine protein ≤ 2 + or ≤ 1000 mg/24h (urine).

Exclusion Criteria

•Active infection requiring intravenous antibiotics and not treated within 1 week prior to enrollment, except for prophylactic antibiotics for needle stick or biopsy
•Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBsAg positive or HBcAb positive with HBV-DNA detection ≥ 10e4), or hepatitis C virus infection (HCV antibody positive with HCV-RNA ≥ ULN)
•Toxicity from prior anticancer therapy has not been reduced to Grade I as defined in CTCAE v5.0 (with the exception of symptoms related to myelosuppression, such as neutropenia, anemia, thrombocytopenia；with the exception of peripheral neurotoxicity with mild symptoms, such as numbness of hands and feet) or to the levels specified in the inclusion criteria. Alopecia and irreversible toxicity from prior anticancer therapy (defined as stable for ≥ 2 months) allowed in the opinion of the investigator/sponsor; irAE in patients who have received prior immunotherapy and who are no longer able to receive immunotherapy as recommended by guidelines
•Patients at risk for active autoimmune diseases, or with a history of autoimmune diseases, may have central nervous system involvement, including but not limited to Crohn's disease, ulcerative colitis, systemic lupus erythematosus, sarcoidosis, Wegener's syndrome, polyangitic granulomatosis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, autoimmune hepatitis, systemic sclerosis, Hashimoto's thyroiditis, autoimmune vasculitis, autoimmune neuropathy (Guillain - Barré syndrome), etc. Except in the following cases: type 1 diabetes, hormone replacement therapy for stable hypothyroidism (Including hypothyroidism caused by autoimmune thyroid disease), psoriasis or vitiligo without systemic treatment, autoimmune diseases caused by B cells or antibodies against autoantigens
•Pulmonary disease defined as ≥ Grade 3 according to NCI-CTCAEv5.0; patients with current or history of interstitial lung disease (ILD)
•Patients with prior organ transplant
•Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to: Have serious heart rhythm or conduction abnormality, such as ventricular arrhythmia, III degree atrioventricular block, etc., which need clinical intervention; At rest, QT interval was prolonged (male QTc \> 450 msec or female QTc \> 470 msec); Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or above cardiovascular and cerebrovascular events occurred within 6 months before the first administration; New York Heart Association (NYHA) heart function classification ≥II heart failure
•History or presence of thrombotic events such as deep venous thrombosis, arterial thrombosis, and pulmonary embolism within 6 months
•Cerebral parenchymal metastasis or meningeal metastasis (except asymptomatic and stable for more than 2 months after treatment), which was judged by the investigator to be not suitable for inclusion
•Uncontrolled pleural effusion with clinical symptoms was judged inappropriate for inclusion by the investigator

Arms & Interventions

GNC-035

Patients receive GNC-035 intravenous infusion (IV, QW) for 2 weeks (a 2-week cycle). Participants with no intolerable AEs could continue for another three cycles

Intervention: GNC-035