Gene Therapy Clinical Trials
Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies
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.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: Sotorasib
- drug: Fulvestrant
- drug: Abemaciclib
- drug: Trastuzumab
- drug: eFT226
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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Lisa Marie Kody
lkody@stanford.edu
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