This is a phase 1b, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics of Sapu003 in combination with Exemestane in in patients with advanced mTOR-sensitive solid tumors (HR+/HER2-negative breast cancer, renal cell carcinoma \[RCC\], neuroendocrine tumors \[NETs\], tuberous sclerosis complex \[TSC\]-associated tumors, and hepatocellular carcinoma \[HCC\]).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Sex and Age: Patients must be ā„ 18 years of age at the time of informed consent.
ā. Cohort A HR+/HER2- Breast Cancer:
ā. Cohort B Other Advanced mTOR-Sensitive Solid Tumors:
ā. Patients must be on stable doses of metformin or statin
ā. Eastern Cooperative Oncology Group (ECOG) performance status ā¤ 2.
ā. Life expectancy ā„ 3 months
ā. Hematology/chemistry: Patient has adequate hematological, renal, and hepatic function as defined by the following Screening laboratory values obtained within 7 days prior to randomization and assessed based on local labs (patients should not have received a transfusion within 7 days before the Screening laboratory assessments):
ā. All other clinical laboratory values deemed as normal or not clinically significant by the Principal Investigator/Sub-Investigator.
Exclusion criteria
ā. Patients with a history of other malignancies, except for adequately treated non-melanoma skin cancer, curatively treated in-situ carcinoma of the cervix, curatively treated in-situ carcinoma of the breast, or other solid tumors curatively treated with no evidence of disease for \> 5 years.
ā. Patients who have not completely recovered from any toxicities from previous chemotherapy, hormone therapy, immunotherapy, target therapy, or radiotherapies ā„ Grade 1 per NCI CTCAE version 5.0, with the exception of alopecia.
What they're measuring
1
Maximum Tolerated Dose (MTD) and Dose Limiting Toxicities (DLTs) of Sapu003 in Patients with Advanced mTOR-Sensitive Solid Tumors
Timeframe: The primary outcome timeframe is assessed during the first 28-day cycle of treatment, specifically looking at dose-limiting toxicities (DLTs) to determine the maximum tolerated dose (MTD) of Sapu003
. Patients who have received any of the following treatments within the specified timeframes prior to screening:
ā. Patients had major surgery within 30 days prior to randomization, or patients have not recovered from prior major surgery.
ā. Sensory / Peripheral neuropathy of \> Grade 1 per NCI CTCAE version 5.0 at Screening.
ā. Patients with active brain metastases. Patients with treated brain metastases are eligible provided they have no evidence of active brain disease and are off of definitive therapy (including steroids) at least 3 months prior to randomization.
ā. Known history or presence of any clinically significant disease or condition other than cancer unless determined as not clinically significant by the Principal Investigator/Sub-Investigator. This includes, but is not limited to, the following: hepatic, renal/genitourinary, gastrointestinal (e.g., intra-abdominal inflammation), cardiovascular (e.g., congestive heart failure, ventricular arrhythmia, myocardial infarction, unstable angina pectoris), cerebrovascular, pulmonary (e.g., interstitial lung disease), endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological, or hematological (e.g., bleeding diathesis or coagulopathy).
ā. History of difficulty with donating blood or difficulty in accessibility of central line.