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

NCT ID: NCT05039931

Last Updated: 2024-07-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2023-06-30

Brief Summary

In this study, the safety, tolerability and preliminary effectiveness of GNC-035 in participants with locally advanced or metastatic solid tumors 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; Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GNC-035

Patients receive GNC-035 as a 24-hour continuous intravenous infusion (cIV, QD) for 2 weeks (a 2-week cycle). Participants with no intolerable AEs could continue for another three cycles.

Group Type: EXPERIMENTAL

GNC-035

Intervention Type: DRUG

Administration by intravenous infusion.

Interventions

GNC-035

Administration by intravenous infusion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. The participants could understand and sign the informed consent form, and must participate voluntarily

2. No gender limit

3. Age: ≥18 years old

4. Histologically or cytologically documented, locally advanced or metastatic solid tumour,and disease progression confirmed by imaging or other objective evidence after having received standard treatment; or patients with refractory solid tumors who cannot tolerate standard treatment or have contraindications to standard treatment

5. Measurable disease at baseline as assessed by the Investigator per RECIST v1.1

6. ECOG Performance Status ≤ 1

7. Life expectancy estimated to be at least 3 months

8. Acceptable bone marrow function： Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L, and hemoglobin ≥ 90 g/L.

9. 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).

10. 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)

11. Coagulation function: fibrinogen ≥ 1.5 g/L, activated partial thromboplastin time (APTT) and prothrombin time (PT) ≤1.5×ULN

12. 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.

4. 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.

5. Pulmonary disease defined as ≥ Grade 3 according to NCI-CTCAEv5.0, including patients with resting dyspnea, or requiring continuous oxygen therapy, or with a history of interstitial lung disease (ILD)

6. Patients with prior organ transplant

7. Left ventricular ejection fraction ≤ 50%, or history of significant cardiac disease within 1 year

8. History or presence of thrombotic events such as deep venous thrombosis, arterial thrombosis, and pulmonary embolism

9. 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

10. 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)

11. Hypertension poorly controlled on medication (systolic > 150 mmHg or diastolic > 100 mmHg)

12. Previous or concomitant central nervous system disease

13. Has receivedany other clinical trial within 4 weeks prior to GNC-035 treatment

Exclusion Criteria

1. Active infection requiring intravenous antibiotics and not treated within 1 week prior to enrollment, except for prophylactic antibiotics for needle stick or biopsy

2. 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SystImmune Inc.

INDUSTRY

Sponsor Role: collaborator

Sichuan Baili Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yongsheng Wang

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

West China Hospital of Sichuan University

Sichuan, Sichuan, China

Countries

China

Other Identifiers

GNC-035-101（V1.1）

Identifier Type: -

Identifier Source: org_study_id