Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0UQXWB
ADC Name
BI-CON-02
Synonyms
BI-CON-02; BI CON 02; BICON02
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Organization
BioIntegrator LLC
Drug Status
Phase 1 (discontinued)
Antibody Name
Trastuzumab
  Antibody Info 
Antigen Name
Receptor tyrosine-protein kinase erbB-2 (ERBB2)
  Antigen Info 
Payload Name
Undisclosed
Therapeutic Target
Stimulator of interferon genes protein (STING1)
  Target Info 
Linker Name
Undisclosed
The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
Indication Phase 1 Phase 1/2 Phase 2 Phase 2/3 Phase 3 New Drug Application Approved
Breast cancer
1 Trials
Trial ID
NCT03062007
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
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Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT03062007
PHASE1
Open-label Study of Safety, Tolerability and Pharmacokinetics of Multiple Doses of BI-CON-02 in Patients With HER2-positive Metastatic Breast Cancer, Previously Treated With Trastuzumab
Undisclosed  NCT03062007
Phase 1
Open-label study of safety, tolerability and pharmacokinetics of multiple doses of BI-CON-02 in patients with HER2-positive metastatic breast cancer, previously treated with trastuzumab.
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 2 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Patients Enrolled
Eligibility: HER2+ (IHC3+/ISH+) metastatic breast cancer patients (&ge;18y, ECOG 0-2) progressing post-trastuzumab, with adequate organ function (ANC &ge;1.5&times;109/L, platelets &ge;100&times;109/L, LVEF >50%). Exclusion: Significant cardiac disease, CNS metastases, prior trastuzumab hypersensitivity &ge;G3, recent anticancer therapy (<4 weeks), HIV/HCV/HBV infection, pregnancy, or investigator-assessed safety concerns.

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Administration Dosage
BI-CON-02 prescribed as intravenous infusion once per 3 weeks. Investigational product therapy during 1 year (up to 18 cycles, duration of 21 days each).
Related Clinical Trial
NCT Number NCT03062007  Clinical Status PHASE1
Clinical Description Open-label Study of Safety, Tolerability and Pharmacokinetics of Multiple Doses of BI-CON-02 in Patients With HER2-positive Metastatic Breast Cancer, Previously Treated With Trastuzumab
Primary Endpoint
The study evaluates treatment-emergent AEs (CTCAE-graded) and determines MTD/RD of BI-CON-02 over 55 weeks, with MTD defined as the highest dose where ≤1/6 patients experience DLTs by Week 3 Day 1, including lab abnormalities and ECG findings.
Other Endpoint
PK parameters (AUC, Cmax, T1/2, Vss, CL) and immunogenicity (anti-BI-CON-02 antibodies) will be analyzed up to 55 weeks to characterize drug exposure and immune response.
Experiment 2 Reporting the Activity Date of This ADC [2]
Related Clinical Trial
NCT Number NCT03062007  Clinical Status Phase 1
Clinical Description Open-label study of safety, tolerability and pharmacokinetics of multiple doses of BI-CON-02 in patients with HER2-positive metastatic breast cancer, previously treated with trastuzumab.
References
Ref 1 Open-label Study of Safety, Tolerability and Pharmacokinetics of Multiple Doses of BI-CON-02 in Patients With HER2-positive Metastatic Breast Cancer, Previously Treated With Trastuzumab
Ref 2 A phase I study of TRS005: An anti-CD20-MMAE antibody-drug conjugate, in relapsed or refractory b cell non-Hodgkin lymphoma. Ann. Oncol. 2022 Sept; 33(7):Supplement S827.