Evaluating GNC-077 for advanced breast cancer and solid tumors

An Open-label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics or Preliminary Efficacy and Antitumor Activity of GNC-077 Multi-specific Antibody Injection in Patients With Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors

This study is testing a new drug called GNC-077 to see if it is safe and effective for people with advanced breast cancer and other solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: Chemotherapy, immunotherapy, radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06609187 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter, dose-escalation phase I clinical study aimed at assessing the safety, tolerability, pharmacokinetics, and preliminary efficacy of GNC-077 in patients with locally advanced or metastatic breast cancer and other solid tumors. The study will involve participants who have measurable lesions and will evaluate the antitumor activity of the treatment. The trial will also include cohort expansions to gather more data on the drug's effects across different patient groups.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with locally advanced or metastatic breast cancer or other solid tumors who have measurable lesions.

Not a fit: Patients with early-stage cancer or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced breast cancer and other solid tumors.

How similar studies have performed: While this approach is part of ongoing research in cancer treatment, the specific drug GNC-077 is novel and has not been extensively tested in previous studies.

Eligibility criteria

Inclusion Criteria:

1. Able to understand the informed consent form, voluntarily participate in and sign the informed consent form;
2. Gender is not limited;
3. Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib);
4. Locally advanced or metastatic breast cancer and other solid tumors;
5. Must have at least one measurable lesion that meets the RECIST v1.1 definition;
6. Have archived primary or recurrent tumor tissue specimens that can be submitted for central review;
7. ECOG ≤1;
8. The expected survival time as judged by the investigators was ≥3 months;
9. Bone marrow function, renal function and liver function should meet the requirements;
10. Coagulation function: fibrinogen ≥1.5g/L; Activated partial thromboplastin time (APTT) ≤1.5×ULN; Prothrombin time (PT) ≤1.5×ULN;
11. Fertile female subjects or male subjects with fertile partners must use highly effective contraception from 7 days before the first dose until 12 weeks after the last dose. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose;
12. Subjects were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.

Exclusion Criteria:

1. 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 first dose; Oral drugs such as fluorouracil;
2. Patients with active infection requiring intravenous antibiotics who did not complete treatment within 1 week before enrollment, except prophylactic antibiotics for puncture or biopsy;
3. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection;
4. 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;
5. Patients at risk for active autoimmune disease or with a history of autoimmune disease may have central nervous system involvement;
6. 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;
7. Patients with previous allogeneic hematopoietic stem cell transplantation or organ transplantation;
8. Had a history of severe cardiovascular and cerebrovascular diseases;
9. Patients had or had thrombotic events such as deep vein thrombosis, arterial thrombosis and pulmonary embolism within 6 months before screening;
10. Brain parenchymal metastases and/or meningeal metastases or spinal cord compression, excluding stable and asymptomatic brain parenchymal metastases;
11. Uncontrolled pleural effusion with clinical symptoms who were judged by the investigator to be ineligible for enrollment;
12. Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
13. 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);
14. Had received a live vaccine within 4 weeks before the trial dose;
15. Other circumstances that the investigator deemed inappropriate for participation in the trial.

Where this trial is running

Beijing, Beijing Municipality

• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Binghe Xu, PHD — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Sa Xiao, PHD

Conditions Breast Cancer; Solid Tumor