Actively Recruiting
A Study of GNC-077 in Patients With Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2026-01-21
20
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
B
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is an open-label, multicenter, dose-escalation and cohort expansion phase I clinical study to evaluate the safety, tolerability, pharmacokinetics characteristics or preliminary efficacy and antitumor activity in patients with locally advanced or metastatic breast cancer and other solid tumors.
CONDITIONS
Official Title
A Study of GNC-077 in Patients With Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign the informed consent form
- Gender not limited
- Age 18 to 75 years (Phase Ia); 18 years and older (Phase Ib)
- Diagnosed with locally advanced or metastatic breast cancer or other solid tumors
- Have at least one measurable lesion based on RECIST v1.1
- Have archived primary or recurrent tumor tissue available for central review
- ECOG performance status of 0 or 1
- Expected survival time of at least 3 months as judged by investigators
- Adequate bone marrow, kidney, and liver function
- Coagulation function within specified limits: fibrinogen ≥1.5 g/L; APTT ≤1.5 times upper limit of normal; PT ≤1.5 times upper limit of normal
- Fertile female or male with fertile partner must use effective contraception from 7 days before first dose until 12 weeks after last dose
- Negative serum pregnancy test within 7 days before first dose for females of childbearing potential
- Able and willing to comply with study visits, treatment plans, lab tests, and other procedures
You will not qualify if you...
- Received chemotherapy, biological therapy, immunotherapy, or other anti-tumor treatments within 4 weeks or 5 half-lives before first dose; Mitomycin and nitrosoureas within 6 weeks; oral drugs such as fluorouracil
- Active infection needing intravenous antibiotics not resolved within 1 week before enrollment (except prophylactic antibiotics for biopsy)
- Positive for HIV antibody, active tuberculosis, active hepatitis B or C infection
- Previous antineoplastic therapy toxicity not reduced to grade 1 or specified level
- Risk for active autoimmune disease or history of autoimmune disease involving central nervous system
- Pulmonary disease grade 3 or higher; history or current interstitial lung disease requiring steroids; grade 2 or higher radiation pneumonitis
- Previous allogeneic hematopoietic stem cell or organ transplantation
- History of severe cardiovascular or cerebrovascular diseases
- Thrombotic events within 6 months before screening
- Brain parenchymal or meningeal metastases or spinal cord compression, except stable, asymptomatic brain metastases
- Uncontrolled pleural effusion with symptoms
- Poorly controlled hypertension (systolic >150 mmHg or diastolic >100 mmHg)
- Participation in clinical trial of unmarketed drug within 4 weeks before study dose
- Received live vaccine within 4 weeks before study dose
- Other conditions deemed inappropriate for participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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