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New treatment option for Breast Cancer
Official title A Study of GNC-077 in Patients With Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors
ClinicalTrials.gov ID: NCT06609187
What this study is testing
What is GNC-077?
GNC-077 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Able to understand the informed consent form, voluntarily participate in and sign the informed consent form;
- Gender is not limited;
- Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib);
- Locally advanced or metastatic breast cancer and other solid tumors;
- Must have at least one measurable lesion that meets the RECIST v1.1 definition;
You likely can't join if
- Chemotherapy, biological therapy, immunotherapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose...
- Patients with active infection requiring intravenous antibiotics who did not complete treatment within 1 week before enrollment, except prophylactic...
- Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection;
- No reduction in toxicity from previous antineoplastic therapy to grade I as defined in CTCAE, version 5.0, or to the level specified in the inclusion...
- Patients at risk for active autoimmune disease or with a history of autoimmune disease may have central nervous system involvement;
- Pulmonary disease defined as ≥ grade 3 according to NCI-CTCAE v5.0; A history of ILD requiring steroid therapy, or current ILD or grade ≥2 radiation...
See the full eligibility criteria
- Able to understand the informed consent form, voluntarily participate in and sign the informed consent form;
- Gender is not limited;
- Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib);
- Locally advanced or metastatic breast cancer and other solid tumors;
- Must have at least one measurable lesion that meets the RECIST v1.1 definition;
- Have archived primary or recurrent tumor tissue specimens that can be submitted for central review;
- ECOG ≤1;
- The expected survival time as judged by the investigators was ≥3 months;
- Bone marrow function, renal function and liver function should meet the requirements;
- Coagulation function: fibrinogen ≥1.5g/L; Activated partial thromboplastin time (APTT) ≤1.5×ULN; Prothrombin time (PT) ≤1.5×ULN;
- Fertile female people or male people with fertile partners must use highly effective contraception from 7 days before the first dose until 12 weeks after the last dose. Female people of childbearing potential must have...
- people were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.
- Chemotherapy, biological therapy, immunotherapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the...
- Patients with active infection requiring intravenous antibiotics who did not complete treatment within 1 week before enrollment, except prophylactic antibiotics for puncture or biopsy;
- Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection;
- No reduction in toxicity from previous antineoplastic therapy to grade I as defined in CTCAE, version 5.0, or to the level specified in the inclusion criteria;
- Patients at risk for active autoimmune disease or with a history of autoimmune disease may have central nervous system involvement;
- Pulmonary disease defined as ≥ grade 3 according to NCI-CTCAE v5.0; A history of ILD requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis;
- Patients with previous allogeneic hematopoietic stem cell transplantation or organ transplantation;
- Had a history of severe cardiovascular and cerebrovascular diseases;
- Patients had or had thrombotic events such as deep vein thrombosis, arterial thrombosis and pulmonary embolism within 6 months before screening;
- Brain parenchymal metastases and/or meningeal metastases or spinal cord compression, excluding stable and asymptomatic brain parenchymal metastases;
- Uncontrolled pleural effusion with clinical symptoms who were judged by the investigator to be ineligible for enrollment;
- Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
- Who had participated in a clinical trial of an unmarketed drug within 4 weeks before the study dose (counted as the end of the last dose);
- Had received a live vaccine within 4 weeks before the trial dose;
- Other circumstances that the investigator deemed inappropriate for participation in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.