Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ichnos Sciences SA
With
Glenmark Pharmaceuticals S.A.
To determine the safety profile, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single agent ISB 1302 in subjects with HER2-positive metastatic breast cancer who have been treated with all known therapies known to confer clinical benefit.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Females with HER2-positive \[IHC 2 +, with FISH confirmation\] or 3+ \[IHC or FISH\] metastatic breast cancer that has progressed on last therapy. No more than 4 lines of therapy in metastatic setting (of which no more than 2 lines should be anti-HER2 antibody-based therapy).
Measurable disease, defined as per RECIST v1.1.
Eastern Cooperative Oncology Group (ECOG ) performance-status score of 2 or less
Adequate bone marrow, renal, and liver function.
Recovered from any previous surgery and no history of major surgery within the last 28 days prior to start of study drug
Must be willing to undergo pre-treatment and on-treatment biopsies in Part 1 and Part 2.
You may not be if
Any suspected or proven immunocompromised state, or infections, such as history of positive human immunodeficiency virus (HIV), known active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV).
Any history or evidence of clinically significant cardiovascular disease.
Evidence of clinically significant cardiovascular and respiratory conditions
Previous antineoplastic treatment with immune checkpoint regulator or comparable immunotherapy within 8 weeks of starting study drug.
Chemotherapy, radiotherapy, molecular-targeted therapy, or biological therapies (including HER2-directed therapies) within 4 weeks of starting study drug
Hormone therapy within 2 weeks of starting study medications.
Diagnosed with another malignancy that requires active therapy
Brain metastases that require directed therapy.
Has not recovered from any therapy related toxicities from previous treatments.
Use of any investigational drug within 4 weeks from the start of study drug.
Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results.
