Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ID: DRG0UQXWB)
ADC Name
BI-CON-02
Synonyms
BI-CON-02; BI CON 02; BICON02
   Click to Show/Hide
Organization
BioIntegrator LLC
Drug Status
Phase 1 (discontinued)
Antibody Name
Trastuzumab
  Antibody Info 
Antigen Name
Receptor tyrosine-protein kinase erbB-2 (HER2)
  Antigen Info 
Payload Name
Undisclosed
Linker Name
Undisclosed
2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
Disease Name Phase 1 Phase 2 Phase 3 Approved
Breast cancer
1 Trials
Clinical trial identifier
NCT03062007
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 2 Activity Data Related to This Level
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.

   Click to Show/Hide
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.