A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With Select Solid Tumors
A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With Select Solid Tumors
The goal of this clinical trial is to evaluate the safety of TOS-358 in adults with select
solid tumors who meet study enrollment criteria. The main questions it aims to answer are:
1. what is the maximum tolerated dose and recommended dose for phase 2?
2. how safe and tolerable is TOS-358 at different dose levels when taken orally once or
twice per day?
solid tumors who meet study enrollment criteria. The main questions it aims to answer are:
1. what is the maximum tolerated dose and recommended dose for phase 2?
2. how safe and tolerable is TOS-358 at different dose levels when taken orally once or
twice per day?
Breast,
Cervical,
Gastrointestinal,
Gynecologic,
Head/Neck,
Lung,
Phase I,
Urologic
Phase I
Adults
Mol. targeted/Immunotherapy/Biologics
Not Available
Berlin, Jordan
National
Vanderbilt University
05-02-2024
Eligibility
18 Years
BOTH
NO
Inclusion Criteria:
Locally advanced, recurrent, or metastatic, incurable (any number of previous lines of therapy is allowed), histologically or cytologically confirmed: colorectal cancer; gastric cancer; non-small cell lung cancer; HER2- breast cancer; squamous cell carcinoma of the head and neck; urothelial cancer; or select gynecologic cancer (ovarian cancer, cervical cancer, or endometrial cancer)
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 disease by RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy 3 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 126 mg/dL AND hemoglobin A1c (HbA1c) 5.7%
Available archived or fresh tumor tissue sample for detection of PIK3CA mutation by central laboratory test
Exclusion Criteria:
Recent systemic anticancer treatment prior to start of treatment
Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway, except for patients with breast cancer
Second malignancy (solid or hematologic) within the past 3 years except: Adequately treated basal cell or squamous cell skin cancer; carcinoma in situ of the cervix, or prostate cancer with Gleason score 6 and undetectable prostate specific antigen over 12 months ;ductal breast carcinoma in situ with full surgical resection (ie, negative margins); treated medullary or papillary thyroid cancer; metaplastic breast cancer
History of diabetes of any type
Body mass index (BMI) 30
Cushing syndrome
Congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months prior to the first dose of investigational product
Known active central nervous system (CNS) metastases.
Locally advanced, recurrent, or metastatic, incurable (any number of previous lines of therapy is allowed), histologically or cytologically confirmed: colorectal cancer; gastric cancer; non-small cell lung cancer; HER2- breast cancer; squamous cell carcinoma of the head and neck; urothelial cancer; or select gynecologic cancer (ovarian cancer, cervical cancer, or endometrial cancer)
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 disease by RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy 3 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 126 mg/dL AND hemoglobin A1c (HbA1c) 5.7%
Available archived or fresh tumor tissue sample for detection of PIK3CA mutation by central laboratory test
Exclusion Criteria:
Recent systemic anticancer treatment prior to start of treatment
Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway, except for patients with breast cancer
Second malignancy (solid or hematologic) within the past 3 years except: Adequately treated basal cell or squamous cell skin cancer; carcinoma in situ of the cervix, or prostate cancer with Gleason score 6 and undetectable prostate specific antigen over 12 months ;ductal breast carcinoma in situ with full surgical resection (ie, negative margins); treated medullary or papillary thyroid cancer; metaplastic breast cancer
History of diabetes of any type
Body mass index (BMI) 30
Cushing syndrome
Congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction within 6 months prior to the first dose of investigational product
Known active central nervous system (CNS) metastases.
