Zotatifin And EIF4A Platinum Helix Inhibition In Resistant AdvancedTNBC

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Zotatifin

    Drug

    Given by IV

  • carboplatin

    Drug

    Given by IV

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: ZOT-CAR: Phase 1b Treatment with Zotatifin + CarboplatinExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Through study completion; an average of 1 year.

Secondary outcomes

Other outcomes

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: