Phase IBPhase 1NCT07783659
Zotatifin And EIF4A Platinum Helix Inhibition In Resistant AdvancedTNBC
A Phase 1 study testing Zotatifin and carboplatin in people with Phase IB and Zotatifin, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To find the optimal (best) recommended dose of zotatifin and carboplatin to treat patients with metastatic or recurrent TNBC. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Zotatifin and carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2027to 30 Jun 2032
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Has at least one measurable lesion per RECIST 1.1
- ECOG performance status ≤ 2 (Karnofsky ≥ 60%,).
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- Participants must have adequate organ and marrow function as defined below:
- absolute neutrophil count ≥ 1,000/mcL
- hemoglobin >9 mg/dL
- platelets ≥ 100,000/mcL
- total bilirubin ≤ institutional upper limit of normal (ULN)
- AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN; ≤ 5 × institutional ULN if confirmed liver metastasis and elevation is deemed to be directly due to metastasis.
- Creatinine clearance ≥30 mL/min (measured by the Cockcroft-Gault equation*).
- Ability to understand and the willingness to sign a written informed consent
- Cognitively impaired subjects will not be enrolled in this study.
- Negative serum pregnancy test within 72 hours of receiving the first dose of the study medication for women of childbearing potential as per institutional guidelines.
- Subjects of childbearing potential must be willing to use highly effective birth control methods or be surgically sterile or abstain from heterosexual activity for the course of the study. Women must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. This includes all female participant s, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:
- Postmenopausal (no menses in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure.
- Approved methods of birth control are as follows: Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control.
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of all study drug administration.
Who cannot join
- 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.
- Participants with uncontrolled intercurrent illness. Medical history or complication considered inappropriate for participation in the study, or a serious physical or psychiatric disease, the risk of which may be increased by participation in the study in the investigator's opinion
- Participants with active infections requiring systemic antibiotics or antifungal or antiviral treatment within 14 days of C1D1 study treatment.
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- Participants with known active Hepatitis B or Hepatitis C infection. Testing is required to establish eligibility. Active Hepatitis B infection is defined as a positive Hepatitis B surface antigen and positive Hepatitis B core antibody test. Active Hepatitis C infection is defined as a quantitative HCV-RNA test with results greater than the lower limit of detection of the assay.
- For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Participant s with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Participant s with known HIV infection, defined as positive for HIV1/2 antibodies. Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- Participant s with psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study due to potential for teratogenic or abortifacient effects.
- Participant s with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Participant s with active brain metastasis if treatment is warranted. Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.
- Participant s with known leptomeningeal disease, defined as unequivocal imaging or cytology-proven disease.
- Participant s with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participant s should be class 2B or better, and EF greater than 45% despite best supportive care.
- Participant s with a history or presence of screening ECG test that is clinically significantly abnormal in the investigator's opinion. Participants with a prolonged Qtc interval > 480 milliseconds (corrected by Fridericia or Bazett formula are excluded, but medically-controlled arrhythmias are allowed.
- Participants with a history of significant cardiac events within 6 months of C1D1. Significant cardiac events include baseline NYHA class III/IV cardiac disease, acute myocardial infarction, severe/unstable angina, cardiomyopathy, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, critical conduction delay, transient ischemic attack or pulmonary embolism.
- Participants who are receiving any other investigational agents.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT MD Anderson Cancer Center
Houston, Texas, 77030
Bora Lim, MD, 713-745-0689, BLim@mdanderson.org
Bora Lim, MD
About this study
To find the optimal (best) recommended dose of zotatifin and carboplatin to treat patients with metastatic or recurrent TNBC.
Read the detailed description
Primary Objectives To determine the optimal biologic dose (OBD) of zotatifin and carboplatin. The OBD will be determined using dose limiting toxicities (DLTs) and ORR.
- Conditions
- Phase IB, Zotatifin, EIF4A, Advanced TNBC, Platinum Helix Inhibition
- Being tested
- Zotatifin, carboplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZotatifinDrug
Given by IV
carboplatinDrug
Given by IV
| Study group | Role | What they receive |
|---|---|---|
| ZOT-CAR: Phase 1b Treatment with Zotatifin + Carboplatin | Experimental | Not described Receives: Drug: Zotatifin; Drug: carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start12 Feb 2027 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phase IBStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas, SJP Biotec
- Responsible party
- Sponsor
- Investigators
- Bora Lim, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783659
- Sponsor's protocol ID
- 2026-0091
- Other IDs
- NCI-2026-06281
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zotatifin And EIF4A Platinum Helix Inhibition In Resistant AdvancedTNBC
- ClinicalTrials.gov ID
- NCT07783659
- Acronym / sponsor ID
- 2026-0091
- Conditions
- Phase IB, Zotatifin, EIF4A, Advanced TNBC, Platinum Helix Inhibition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas, SJP Biotec
- Study start
- 12 Feb 2027 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To find the optimal (best) recommended dose of zotatifin and carboplatin to treat patients with metastatic or recurrent TNBC.
Detailed description
Primary Objectives To determine the optimal biologic dose (OBD) of zotatifin and carboplatin. The OBD will be determined using dose limiting toxicities (DLTs) and ORR.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZOT-CAR: Phase 1b Treatment with Zotatifin + Carboplatin | Experimental | Drug: Zotatifin, Drug: carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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.
- Has at least one measurable lesion per RECIST 1.1
Key exclusion criteria (19 listed)
- 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.
- Participants with uncontrolled intercurrent illness. Medical history or complication considered inappropriate for participation in the study, or a serious physical or psychiatric disease, the risk of which may be increased by participation in the study in the investigator's opinion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZotatifinGiven by IV | Drug | ZOT-CAR: Phase 1b Treatment with Zotatifin + Carboplatin |
| carboplatinGiven by IV | Drug | ZOT-CAR: Phase 1b Treatment with Zotatifin + Carboplatin |
Primary outcome
Safety and adverse events (AEs).
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bora Lim, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Zotatifin and carboplatin in people with Phase IB and Zotatifin, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bora Lim, MD (713-745-0689, BLim@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs). (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.