Status and phase
Conditions
Treatments
About
The purpose of this study is to determine whether ETBX-021 is safe and effective in the treatment of unresectable locally advanced or metastatic HER2-low-expressing breast cancer.
Full description
This is a Phase I trial in subjects with unresectable locally advanced or metastatic HER2-low expressing (IHC 1+ or 2+) breast cancer. The study will be conducted in two parts: the first part will involve dose escalation using a 3 + 3 design, and the second part will involve the expansion of the MTD or HTD to further evaluate safety, preliminary efficacy, and immunogenicity. In the first part, 3 to 6 subjects will be sequentially enrolled starting at dose cohort 1. Subjects will be assessed for dose-limiting toxicities (DLTs).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Age ≥ 18 years.
Male or female.
Ability to understand and provide signed informed consent that fulfills Institutional Review Board (IRB)'s guidelines.
Histologically confirmed unresectable locally advanced or metastatic breast cancer that expresses HER2 (IHC 1+ or 2+), derived from the most recent metastatic biopsy sample available.
Tumor tissue (block or slides) and whole blood sample available for analysis. Archival tissue is permitted.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Concurrent hormone therapy is permitted.
Subjects who have received prior HER2-targeted immunotherapy (vaccine) are eligible for this trial if this treatment was discontinued at least 3 months prior to enrollment.
Resolution of all toxic side effects of prior chemotherapy, radiotherapy, or surgical procedures to NCI CTCAE Grade ≤ 1.
Subjects who are taking medications that do not have a known history of immunosuppression are eligible for this trial.
Adequate hematologic function at screening, as follows:
Adequate renal and hepatic function at screening, as follows:
Multigated acquisition (MUGA) scan or echocardiogram with LVEF ≥ institutional LLN. Same imaging modality is to be used throughout the study.
Female subjects of childbearing potential and women < 12 months since the onset of menopause must agree to use acceptable contraceptive methods for the duration of the study and for 7 months following the last injection of study medication. If employing contraception, two of the following precautions must be used: vasectomy of partner, tubal ligation, vaginal diaphragm, intrauterine device, condom and spermicidal (gel/foam/cream/vaginal suppository), or total abstinence. Male subjects must be surgically sterile or must agree to use a condom and acceptable contraceptive method with their partner. Female subjects who are post-menopausal are defined as those with an absence of menses for > 12 consecutive months.
Ability to attend required study visits and return for adequate follow up, as required by this protocol.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
3 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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