About this trial
To find the optimal (best) recommended dose of zotatifin and carboplatin to treat patients with metastatic or recurrent TNBC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have histologically confirmed malignancy that is metastatic or locally recurrent unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
Participants must have histologically or cytologically confirmed non-IBC triple negative breast cancers, defined here as ER<1%, PR<1% and HER2 negative per ASCO CAP 2018 guideline and have received at least 2 lines of therapy during metastatic treatment, OR Inflammatory breast cancer (IBC) clinically confirmed (³25) and that is ER<10% and PR<10% without limits of previous line of therapy.
At least 1 week since prior chemotherapy or radiation therapy. At least 2 weeks since prior use of strong or moderate inhibitors or inducers of CYP3A4.
Age ≥18 years.
Disqualifiers
Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) except for alopecia. Note: Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to > Grade 2 for at least 3 months prior to [enrollment/Cycle 1 Day 1] and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, including: Chemotherapy-induced neuropathy, Fatigue, Residual toxicities from prior IO treatment: Grade 1 or Grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism, Type I diabetes, Hyperglycemia, Adrenal insufficiency, Adrenalitis and Skin hypopigmentation (vitiligo)
Participants with a history of interstitial lung disease (past or current) or active, non-infectious pneumonitis.
Participants with active autoimmune disease requiring systemic immunosuppression with corticosteroids (> 10 mg/day of prednisone or equivalent) or immunosuppressive drugs within 2 years before the first dose of study treatment.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin or zotatifin.
Trial design
Single group
Treatments tested in this trial
Zotatifin
DrugGiven by IV
carboplatin
DrugGiven by IV
Treatment groups
Trial outcomes
Primary outcomes
Safety and adverse events (AEs).
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
Cancer Prevention Research Institute of Texas
Collaborator
SJP Biotec
Collaborator
This trial is not recruiting at the moment. You can still explore other options: