Actively Recruiting
A Phase 1b, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sapu003 in Advanced mTOR-Sensitive Solid Tumors With or Without Exemestane
Led by SAPU NANO (US) LLC · Updated on 2026-01-27
27
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and pharmacokinetics of Sapu003, a drug given intravenously, alone or in combination with exemestane, in adults with advanced mTOR-sensitive solid tumors. These tumors include hormone receptor-positive, HER2-negative breast cancer, renal cell carcinoma, neuroendocrine tumors, tuberous sclerosis complex-associated tumors, and hepatocellular carcinoma. This phase 1b open-label study aims to find the maximum tolerated dose of Sapu003 and assess its preliminary effects on tumors. The study has two groups: Cohort A includes postmenopausal women with advanced breast cancer who receive weekly intravenous Sapu003 at varying doses combined with daily oral exemestane. Cohort B includes adults with other advanced solid tumors who receive only Sapu003 weekly by intravenous infusion. Each treatment cycle lasts 28 days, and dosing levels being tested are 5 mg/m², 7.5 mg/m², and 10 mg/m². Participants will undergo safety and laboratory evaluations, including blood tests and tumor assessments, throughout the study. Pharmacokinetic measurements will be taken during the first two treatment cycles to understand how the drug behaves in the body. The main outcome is to identify dose-limiting toxicities and establish the maximum tolerated dose within the first 28 days. Secondary measures include drug levels, tumor response, progression, and survival, monitored until study completion. The study participation may last several months with regular visits for infusions and assessments.
CONDITIONS
Brief Title
Sapu003 in Advanced mTOR-sensitive Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be 18 years or older at the time of consent.
- Cohort A: Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer.
- Cohort B: Adults with advanced renal cell carcinoma, neuroendocrine tumors, tuberous sclerosis complex-associated tumors, or hepatocellular carcinoma.
- Advanced or metastatic disease confirmed by biopsy or cytology.
- For breast cancer: Stage IV or locally advanced disease, failed prior endocrine therapy, or relapse after chemotherapy.
- For other tumors: Measurable or evaluable disease per RECIST v1.1.
- Progressed on or intolerant to at least one prior standard therapy unless none exists.
- Stable doses of metformin or statin.
- ECOG performance status of 2 or less.
- Life expectancy of at least 3 months.
- Adequate blood counts and organ function within 7 days before randomization.
- Non-lactating and agreeing to use effective contraception if of reproductive potential.
- Able and willing to follow study procedures and understand the study.
You will not qualify if you...
- History of other cancers unless treated and disease-free for over 5 years.
- Not fully recovered from toxicities of prior therapies above Grade 1 except alopecia.
- Recent chemotherapy, immunotherapy, hormone therapy, or radiotherapy within specified timeframes before screening.
- Major surgery within 30 days prior to randomization or incomplete recovery.
- Sensory or peripheral neuropathy greater than Grade 1.
- Active brain metastases; treated brain metastases must be stable and off steroids for at least 3 months.
- Significant other diseases or conditions affecting safety as judged by investigators.
- History of difficulty donating blood or central line access problems.
- HIV, Hepatitis B or C infection.
- Alcohol or drug abuse within one year before randomization.
- Known allergy or severe reaction to everolimus or related compounds.
- Participation in other investigational studies within 30 days before randomization.
- Use of strong CYP450 enzyme inhibitors or inducers within 14 days prior to randomization.
- Active infections requiring 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive weekly intravenous infusions of Sapu003 at varying doses in 28-day cycles. Participants in Cohort A also take daily oral exemestane. Treatment continues with dose escalation to determine the maximum tolerated dose.
Weekly visits for infusions during each 28-day cycle
Trial Site Locations
Total: 1 location
1
SOCRU
Adelaide, Australia
Actively Recruiting
Research Team
C
Cynthia Lee
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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