A Study of GNC-077 in Patients With Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors

NCT06609187 | Recruiting Phase 1

• 1 other identifier: GNC-077-102
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer; Solid Tumor

Outcome Measures

Primary Outcomes (4)

• Phase Ia: Dose limiting toxicity (DLT)

  DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration.

  Up to 21 days after the first dose

• Phase Ia: Maximum tolerated dose (MTD)

  MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle .

  Up to 21 days after the first dose

• Phase Ia: Treatment-Emergent Adverse Event (TEAE)

  TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of GNC-077 . The type, frequency and severity of TEAE will be evaluated during the treatment of GNC-077.

  Up to approximately 24 months

• Phase Ib: Recommended Phase II Dose (RP2D)

  The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of GNC-077.

  Up to approximately 24 months

Secondary Outcomes (12)

• Cmax

  Up to approximately 24 months

• Tmax

  Up to approximately 24 months

• AUC0-inf

  Up to approximately 24 months

• AUC0-t

  Up to approximately 24 months

• CL (Clearance)

  Up to approximately 24 months

Study Arms (1)

GNC-077

EXPERIMENTAL

Participants receive GNC-077 as intravenous infusion for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Drug: GNC-077

Interventions

GNC-077 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

GNC-077

Eligibility Criteria

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

You may qualify 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;
• 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 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;
• Subjects were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.

You may not qualify if:

• 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;
• 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;
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Binghe Xu, PHD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sa Xiao, PHD

CONTACT

15013238943; xiaosa@baili-pharm.com

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: September 20, 2024
• First Posted: September 24, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

CN (1)