A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer
A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer
The goal of this clinical trial is to evaluate the safety and efficacy of TOS-358 in women with HR+ HER2- metastatic breast cancer whose tumors have a mutation in PIK3CA and who meet all other study enrollment criteria. The main questions it aims to answer are:
1. Phase 1a: what is the maximum tolerated dose and recommended dose for phase 2?
2. Phase 1a: how safe and tolerable is TOS-358 at different dose levels when taken orally once or twice per day?
3. Phase 1b: how safe and effective is TOS-358 when given with standard of care medicines for HR+HER2- metastatic breast cancer (fulvestrant and CDK4/6i)
1. Phase 1a: what is the maximum tolerated dose and recommended dose for phase 2?
2. Phase 1a: how safe and tolerable is TOS-358 at different dose levels when taken orally once or twice per day?
3. Phase 1b: how safe and effective is TOS-358 when given with standard of care medicines for HR+HER2- metastatic breast cancer (fulvestrant and CDK4/6i)
Breast,
Cervical,
Gastrointestinal,
Gynecologic,
Head/Neck,
Lung,
Phase I,
Urologic
Phase I
Adults
Mol. targeted/Immunotherapy/Biologics
Not Available
Abramson, Vandana
National
Vanderbilt University
05-02-2024
Eligibility
18 Years and older
FEMALE
false
Inclusion Criteria:
Locally advanced, recurrent, or metastatic HR +/HER2- breast cancer
Up to 3 prior lines of therapy for metastatic disease
Willing and able to provide written informed consent for this study
Adults 18 years old at time of consent
Known PIK3CA mutations or amplifications as determined at a CAP/CLIA-certified or equivalently accredited diagnostic laboratory using a validated test
Measurable or evaluable disease by RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy 6 months, as determined by the investigator
Adequate bone marrow, liver, and kidney function within 14 days prior to first dose of investigational product
Fasting plasma glucose = 140 mg/dL AND hemoglobin A1c (HbA1c) = 7.0%
Available archived or fresh tumor tissue sample for detection of PIK3CA mutation by central laboratory test
Exclusion Criteria:
Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2
Known active central nervous system (CNS) metastases
PTEN mutations
Locally advanced, recurrent, or metastatic HR +/HER2- breast cancer
Up to 3 prior lines of therapy for metastatic disease
Willing and able to provide written informed consent for this study
Adults 18 years old at time of consent
Known PIK3CA mutations or amplifications as determined at a CAP/CLIA-certified or equivalently accredited diagnostic laboratory using a validated test
Measurable or evaluable disease by RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy 6 months, as determined by the investigator
Adequate bone marrow, liver, and kidney function within 14 days prior to first dose of investigational product
Fasting plasma glucose = 140 mg/dL AND hemoglobin A1c (HbA1c) = 7.0%
Available archived or fresh tumor tissue sample for detection of PIK3CA mutation by central laboratory test
Exclusion Criteria:
Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2
Known active central nervous system (CNS) metastases
PTEN mutations
