Actively Recruiting
Sapu003 in Advanced mTOR-sensitive Solid Tumors
Led by SAPU NANO (US) LLC · Updated on 2026-01-27
27
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 \[HCC\]).
CONDITIONS
Official Title
Sapu003 in Advanced mTOR-sensitive Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older
- Postmenopausal women with HR+/HER2-negative breast cancer for Cohort A
- Histologically or cytologically confirmed advanced or metastatic HR+/HER2-negative breast cancer for Cohort A
- Stage IV or locally advanced breast cancer for Cohort A
- Failed prior endocrine therapy or relapsed within 6 months of adjuvant chemotherapy for Cohort A
- Histologically or cytologically confirmed advanced or metastatic RCC, NETs, TSC-associated tumors, or HCC for Cohort B
- Measurable or evaluable disease per RECIST v1.1 for Cohort B
- Progressed on or intolerant to at least one prior standard therapy for Cohort B, unless no effective therapy exists
- Stable doses of metformin or statin
- ECOG performance status of 0, 1, or 2
- Life expectancy of 3 months or more
- Adequate blood counts and organ function as specified within 7 days prior to randomization
- Non-lactating patients
- Female patients of reproductive potential must use effective contraception during and for 8 weeks after the study
- Male patients with female partners of reproductive potential must use effective contraception during and for 4 weeks after the study
- Able and willing to comply with all protocol requirements
- Able to understand and provide informed consent
You will not qualify if you...
- History of other malignancies except certain treated cancers with no disease for over 5 years
- Unresolved toxicities greater than Grade 1 from prior therapies except alopecia
- Prior chemotherapy within 30 days (42 days for some drugs), immunotherapy, hormonal therapy, or radiotherapy within 30 days before screening
- Radiotherapy not allowed during the study
- Major surgery within 30 days prior to randomization or incomplete recovery from surgery
- Sensory or peripheral neuropathy greater than Grade 1
- Active brain metastases (treated brain metastases allowed if stable for 3 months)
- Significant other medical conditions unless deemed not clinically significant
- History of difficulty donating blood or accessing central line
- Known HIV, Hepatitis B, or Hepatitis C infection
- Alcohol or drug abuse within one year prior to randomization
- Hypersensitivity to everolimus, rapamycin derivatives, or excipients
- Severe allergic reactions
- Participation in another clinical trial with experimental therapy within 30 days
- Use of strong CYP450 inhibitors or inducers within 14 days before randomization until study end
- Acute infection requiring antibiotics, antiviral, or antifungal treatment within 14 days prior to randomization
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
SOCRU
Adelaide, Australia
Actively Recruiting
Research Team
C
Cynthia Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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