A Study of GNC-035, a Tetra-specific Antibody, in Participants With Locally Advanced or Metastatic Breast Cancer

NCT05160545 | Active Not Recruiting Phase 1

• 1 other identifier: GNC-035-103
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 6

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.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (5)

• DLT

  Dose limiting toxicity

  Up to 2 weeks

• MTD or MAD

  Maximum tolerated dose or maximum administrated dose

  Up to 2 weeks

• TEAE

  Treatment-Emergent Adverse Event

  Up to 2 weeks

• The recommended dose for future clinical study

  The recommended dose for future clinical study

  Up to 2 weeks

• RP2D

  Recommended phase II dose

  Up to 2 years

Secondary Outcomes (9)

• AESI

  Up to 2 years

• Cmax

  Up to 2 weeks

• Tmax

  Up to 2 weeks

• T1/2

  Up to 2 weeks

• Incidence and titer of ADA

  Up to 2 years

Study Arms (1)

GNC-035

EXPERIMENTAL

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

Drug: GNC-035

Interventions

GNC-035 DRUG

Administration by intravenous infusion

GNC-035

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Acceptable liver function:
• AST and ALT ≤ 3.0xULN (≤ 5.0ULN for patients with tumor infiltrative changes in the liver)
• Total bilirubin ≤ 1.5xULN (≤ 3ULN for Gilbert's syndrome)
• Coagulation function: fibrinogen ≥ 1.5 g/L, activated partial thromboplastin time (APTT) and prothrombin time (PT) ≤1.5×ULN
• Female participants with fertility or male participants whose partner(s) are fertile must take effective contraceptive measures from 7 days prior to the first administration to 12 weeks after the administration. Female participants with fertility must have a negative serum/urine pregnancy test in 7 days prior to the first dose

You may not qualify if:

• 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)
• 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
• Received chemotherapy, molecular targeted therapy, etc., at 14 or 5 half-lives (whichever is shorter) of the first dose. Patients who have received radiotherapy, antibody therapy (such as PD-L1) or study drug within 28 days
• Patients who had undergone major surgery within 28 days prior to dosing in this study, or who were scheduled to undergo major surgery during this study ("major surgery"was defined by the investigator)
• Hypertension poorly controlled on medication (systolic \> 150 mmHg or diastolic \> 100 mmHg)
• Has receivedany other clinical trial within 4 weeks prior to GNC-035 treatment
• Other conditions that the investigator considers inappropriate for participation in this clinical trial

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (6)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Location

Dongguan People's Hospital

Dongguan, Guangdong, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

The Third Hospital of Changsha

Changsha, Hunan, China

Location

West China Hospital，Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Erwei Song

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Herui Yiao

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 16, 2021
• Study Start: November 26, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)