A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With HR+ Breast Cancer and Other Select Solid Tumors

Launched by TOTUS MEDICINES · Jan 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called TOS-358 to see how safe it is for adults with certain types of solid tumors, such as colorectal cancer, gastric cancer, non-small cell lung cancer, and several others. The main goals are to find out the highest dose that patients can safely take and to see how well they tolerate the medication when taken by mouth once or twice a day. The trial is currently looking for participants who are 18 years or older and have specific types of tumors that have been confirmed by medical tests. Participants must also have certain health conditions, like having a specific genetic mutation, and be able to provide consent for the study.

If you join the trial, you can expect to take the medication and have regular check-ups to monitor your health and any side effects. It’s important to note that there are some criteria that would disqualify someone from participating, such as recent cancer treatments or certain health conditions like diabetes. Overall, this trial aims to gather important information that could help improve treatment options for patients with these types of cancers.

Gender

ALL

Eligibility criteria

• • Key Inclusion Criteria
• • Locally advanced, recurrent, or metastatic, incurable (any number of previous lines of therapy is allowed), histologically or cytologically confirmed; HR +/HER2- breast cancer; squamous cell carcinoma of the head and neck; urothelial cancer; or endometrial cancer with no more than 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 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
• • Key Exclusion Criteria
• • Recent systemic anticancer treatment prior to start of treatment (EXCEPTION: Patients with breast cancer who were receiving a fulvestrant-containing regimen at the time of informed consent may remain on fulvestrant while receiving study treatment)
• • For non-breast cancer: prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway,
• • Has an established diagnosis of diabetes mellitus type 1 or has uncontrolled diabetes mellitus type 2 requiring antihyperglycemic medication
• • Known active central nervous system (CNS) metastases.