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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05039931
Recruitment Status : Recruiting
First Posted : September 10, 2021
Last Update Posted : September 10, 2021
SystImmune Inc.
Information provided by (Responsible Party):
Sichuan Baili Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE August 22, 2021
First Posted Date  ICMJE September 10, 2021
Last Update Posted Date September 10, 2021
Actual Study Start Date  ICMJE June 8, 2021
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2021)
  • DLT [ Time Frame: Up to 2 weeks ]
    Dose limiting toxicity
  • MTD or MAD [ Time Frame: Up to 2 weeks ]
    Maximum tolerated dose or maximum administrated dose
  • TEAE [ Time Frame: Up to 2 years ]
    Treatment-Emergent Adverse Event
  • The recommended dose for future clinical study [ Time Frame: Up to 2 weeks ]
    The recommended dose for future clinical study
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2021)
  • AESI [ Time Frame: Up to 2 years ]
    Adverse Events of special interest
  • Cmax [ Time Frame: Up to 2 weeks ]
    Maximum serum concentration of GNC-035
  • Tmax [ Time Frame: Up to 2 weeks ]
    Time to maximum serum concentration (Tmax) of GNC-035
  • T1/2 [ Time Frame: Up to 2 weeks ]
    Half-life of GNC-035
  • Incidence and titer of ADA [ Time Frame: Up to 2 years ]
    Anti-drug antibody
  • ORR [ Time Frame: Up to 2 years ]
    Objective Response Rate
  • DCR [ Time Frame: Up to 2 years ]
    Disease Control Rate
  • PFS [ Time Frame: Up to 2 years ]
    Progression-free Survival
  • DOR [ Time Frame: Up to 2 years ]
    Duration of Response
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Study of GNC-035, a Tetra-specific Antibody, in Participants With Locally Advanced or Metastatic Solid Tumors
Official Title  ICMJE An Open-Label, Multi-Center, Phase I Study to Evaluate the Safety, Tolerability,Pharmacokinetic/Pharmacodynamics and Anti-tumor Activity of Tetra-specific Antibody GNC-035 in Participants With Locally Advanced or Metastatic Solid Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Solid Tumor
Intervention  ICMJE Drug: GNC-035
Administration by intravenous infusion.
Study Arms  ICMJE Experimental: 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.
Intervention: Drug: GNC-035
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 7, 2021)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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)
  3. Toxicity from prior anticancer therapy has not been reduced to Grade I as defined in CTCAE v5.0 (with the exception of symptoms related to myelosuppression, such as neutropenia, anemia, thrombocytopenia) or to the levels specified in the inclusion criteria. Alopecia and irreversible toxicity from prior anticancer therapy (defined as stable for ≥ 2 months) allowed in the opinion of the investigator/sponsor; irAE in patients who have received prior immunotherapy and who are no longer able to receive immunotherapy as recommended by guidelines
  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hai Zhu +86-13980051002
Contact: Sa Xiao +86-15013238943
Listed Location Countries  ICMJE China
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT05039931
Other Study ID Numbers  ICMJE GNC-035-101(V1.1)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sichuan Baili Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators  ICMJE SystImmune Inc.
Investigators  ICMJE
Principal Investigator: Yongsheng Wang West China Hospital
PRS Account Sichuan Baili Pharmaceutical Co., Ltd.
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP