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Breast CancerPhase 1NCT05160545

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

A Phase 1 study testing GNC-035 in people with Breast Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 6 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
GNC-035
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
6 sitesChina
Study dates
26 Nov 2021to Dec 2025
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • The subject is able and willing to follow the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.

Who cannot join

  • 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
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  • 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
  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui

  • The Third Hospital of Changsha

    Changsha, Hunan

  • West China Hospital，Sichuan University

    Chengdu, Sichuan

  • Dongguan People's Hospital

    Dongguan, Guangdong

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

    Guangzhou, Guangdong, 510120

  • ZhuJiang Hospital of Southern Medical University

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: 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

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
Being tested
GNC-035
Keywords
Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GNC-035Drug

    Administration by intravenous infusion

Study groups in NCT05160545
Study groupRoleWhat they receive
GNC-035ExperimentalPatients 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
Receives: Drug: GNC-035

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DLT

    Dose limiting toxicity

    Measured: Up to 2 weeks

  2. MTD or MAD

    Maximum tolerated dose or maximum administrated dose

    Measured: Up to 2 weeks

  3. TEAE

    Treatment-Emergent Adverse Event

    Measured: Up to 2 weeks

  4. The recommended dose for future clinical study

    The recommended dose for future clinical study

    Measured: Up to 2 weeks

  5. RP2D

    Recommended phase II dose

    Measured: Up to 2 years

Secondary outcomes (9)

  1. AESI

    Adverse Events of special interest

    Measured: Up to 2 years

  2. Cmax

    Maximum serum concentration of GNC-035

    Measured: Up to 2 weeks

  3. Tmax

    Time to maximum serum concentration (Tmax) of GNC-035

    Measured: Up to 2 weeks

  4. T1/2

    Half-life of GNC-035

    Measured: Up to 2 weeks

  5. Incidence and titer of ADA

    Anti-drug antibody

    Measured: Up to 2 years

  6. ORR

    Objective Response Rate

    Measured: Up to 2 years

  7. DCR

    Disease Control Rate

    Measured: Up to 2 years

  8. PFS

    Progression-free Survival

    Measured: Up to 2 years

  9. DOR

    Duration of Response

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2021
  2. Study start26 Nov 2021
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05160545
Sponsor's protocol ID
GNC-035-103
Status last verified
Sep 2025
First submitted
7 Dec 2021
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GNC-035 in people with Breast Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: Up to 2 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05160545.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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