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Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies
Recruiting
I'm InterestedTrial ID: NCT04092673
Purpose
This clinical trial is a Phase 1-2, open-label, sequential-group, dose-escalation and
cohort-expansion study evaluating the safety, pharmacokinetics (PK), pharmacodynamics, and
antitumor activity of Zotatifin (eFT226) in subjects with selected advanced solid tumor
malignancies.
Official Title
A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Intravenous Zotatifin (eFT226) in Subjects With Selected Advanced Solid Tumor Malignancies
Stanford Investigator(s)
Jennifer Caswell-Jin
Assistant Professor of Medicine (Oncology)
Eligibility
Key Criteria:
Parts 1a and 1b (Dose Escalation + Fulvestrant):
- Patient has histological or cytological confirmation of breast cancer.
- Patient has metastatic disease or locoregionally recurrent disease which is refractory
or intolerant to existing therapy(ies) known to provide clinical benefit.
- Patient has had prior chemotherapy, endocrine therapy, or other therapy as follows:
- Minimum of one prior line of therapy for advanced/metastatic disease.
- Maximum of five prior lines of therapy for advanced/metastatic disease.
- Recurrence or progression on at least one line of endocrine therapy in the
advanced/metastatic disease setting.
- Prior treatment has included a CDK4/6 inhibitor.
- Tumor is ER+ (defined as ER IHC staining > 0%).
Cohort EMNK:
- Patient has undergone treatment with platinum-based chemotherapy and an anti-PD-1/L1
agent, if appropriate.
- Tumor has a known KRAS-activating mutation; Patients with KRAS G12C mutations are
excluded.
Cohort EMBF:
- Patient has had prior chemotherapy, endocrine therapy, or other therapy as follows:
- Minimum of one prior line of therapy for advanced/metastatic disease.
- Maximum of five prior lines of therapy for advanced/metastatic disease.
- Recurrence or progression on at least one line of endocrine therapy in the
advanced/metastatic disease setting, which may include combination therapy (eg,
with a CDK4/6 inhibitor).
- Tumor is ER+ (defined as ER IHC staining > 0%) and has FGFR amplification.
Cohort EMBH:
- Patient has had prior chemotherapy, endocrine therapy, or other therapy as follows:
- Minimum of one prior line of therapy for advanced/metastatic disease.
- Minimum of one line of HER2-directed therapy Note: Prior treatment with CDK4/6
inhibitors is permitted.
- Tumor is ER+ (defined as ER IHC staining > 0%) and HER2+ (defined as HER2 3+ IHC
staining or HER2 2+ and FISH+).
Cohort ECNS:
- Patient has histologically or cytologically confirmed stage IIIB (pleural or
pericardial effusion) or stage IV NSCLC.
- Patient has undergone treatment with platinum-based chemotherapy and an anti-PD-1/L1
agent, if appropriate. Note: Patients who have declined approved therapy(ies) or who
per treating physician are not eligible for approved therapy(ies) (eg, due to
intolerance) may be eligible following discussion with the Medical Monitor.
- Tumor has a known G12C KRAS-activating mutation. Note: Patients who have been
previously treated with KRAS-specific therapy are excluded.
Cohort ECBF:
- Patient has had prior chemotherapy, endocrine therapy, or other therapy as follows:
- Minimum of one prior line of therapy for advanced/metastatic disease.
- Maximum of five prior lines of therapy for advanced/metastatic disease.
- Recurrence or progression on at least one line of endocrine therapy in the
advanced/metastatic disease setting.
- Prior treatment has included a CDK4/6 inhibitor.
- Tumor is ER+ (defined as ER IHC staining > 0%).
Cohort ECBF+A:
- Patient has had prior chemotherapy, endocrine therapy, or other therapy as follows:
- Minimum of one prior line of therapy for advanced/metastatic disease.
- Maximum of five prior lines of therapy for advanced/metastatic disease.
- Recurrence or progression on at least one line of endocrine therapy in the
advanced/metastatic disease setting.
- Tumor is ER+ (defined as ER IHC staining > 0%) and HER2- (defined as absence of HER2
3+ IHC staining and/or absence of FISH+).
Cohort ECBT:
- Patient has progressed after treatment with at least one approved anti-HER2 agent and
has been administered at least one line of chemotherapy.
- Tumor is HER2+ (defined as HER2 3+ IHC staining or HER2 2+ and FISH+). Cohorts EMBF,
EMBH, ECBF, ECBF+A: There is no limit on the number of lines of prior endocrine
therapies.
Cohort ECBF-D1:
- Patient has metastatic disease or locoregionally recurrent disease which is refractory
or intolerant to existing therapy(ies) known to provide clinical benefit.
- Patient has had prior chemotherapy, endocrine therapy, or other therapy as follows:
- Minimum of one prior line of therapy for advanced/metastatic disease.
- Maximum of five prior lines of therapy for advanced/metastatic disease.
- Recurrence or progression on at least one line of endocrine therapy in the
advanced/metastatic disease setting.
- Prior treatment has included a CDK4/6 inhibitor.
- Tumor is ER+ (defined as ER IHC staining > 0%).
- Tumor has amplification of Cyclin D1 as determined by next generation sequencing or in
situ hybridization.
Intervention(s):
drug: Sotorasib
drug: Fulvestrant
drug: Abemaciclib
drug: Trastuzumab
drug: eFT226
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Lisa Marie Kody
lkody@stanford.edu