Breast Cancer MetastaticPhase 1NCT07369505
Sapu003 in Advanced mTOR-sensitive Solid Tumors
A Phase 1 study testing Sapu003 and Exemestane 25 MG in people with Breast Cancer Metastatic and Renal Cell Carcinoma (RCC), run by SAPU NANO (US) LLC at 1 site in Australia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Metastatic, Renal Cell Carcinoma (RCC), Neuroendocrine Tumors
- What is being tested?
- Sapu003 and Exemestane 25 MG
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Dec 2025to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sex and Age: Patients must be ≥ 18 years of age at the time of informed consent.
- Cohort A (HR+/HER2- breast cancer): Eligible patients must be postmenopausal women, defined as women ≥ 18 years of age with amenorrhea for ≥ 12 consecutive months without another pathophysiological cause.
- Cohort B (RCC, NETs, TSC-associated tumors, HCC): Eligible patients include both male and female adults with advanced disease.
- Cohort A HR+/HER2- Breast Cancer:
- Eligible patients must meet all of the following:
- Has histologically or cytologically documented advanced (metastatic or unresectable) hormone receptor-positive, HER2 negative breast cancer (advanced HR+ BC)
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- Has stage IV or locally advanced breast cancer per the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, Seventh Edition;
- Has failed any combination endocrine therapy or relapse within 6 months of adjuvant chemotherapy for metastatic or locally advanced disease. Prior therapy should have included a non-steroidal aromatase inhibitor unless clinically contraindicated;
- Has agreed to participate in the study and signed the informed consent form prior to participation in any study activities.
- Cohort B Other Advanced mTOR-Sensitive Solid Tumors:
- Eligible patients must meet all of the following:
- Has histologically or cytologically confirmed advanced (metastatic or unresectable) disease in one of the following tumor types:
- Renal Cell Carcinoma (RCC)
- Neuroendocrine Tumors (NETs)
- Tuberous Sclerosis Complex (TSC)-associated tumors
- Hepatocellular Carcinoma (HCC)
- Has disease that is measurable and/or evaluable per RECIST v1.1 (or relevant criteria, if applicable).
- Has progressed on or is intolerant to at least one prior line of standard therapy appropriate for the specific tumor type, unless no effective standard therapy exists.
- Has agreed to participate in the study and signed the informed consent form prior to participation in any study activities.
- Patients must be on stable doses of metformin or statin
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Life expectancy ≥ 3 months
- 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):
- Absolute neutrophil count (ANC) ≥ 2,000 cells/mm3 (2 x109/L)
- Platelet count ≥ 100,000 cells/mm3 (100x109/L)
- Hemoglobin≥ 9 g/dL
- Serum creatinine≤ 1.5 x the upper limit of normal (ULN)
- Total bilirubin ≤1.5 x ULN or direct bilirubin ≤1 x ULN for patients with total bilirubin levels > 1.5 ULN
- AST (SGOT) / ALT (SGPT) ≤ 2.5 x ULN (≤5 x ULN for patients with metastases.)
- GFR ≥ 50 mL/min/1.73m2 by the CKD-EPI or MDRD formulas.
- All other clinical laboratory values deemed as normal or not clinically significant by the Principal Investigator/Sub-Investigator.
- Breastfeeding: Patients must be non-lactating. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding must be discontinued prior to the first dose of study drug.
- Female patients of reproductive potential to avoid becoming pregnant and to use effective contraception during the study and for 8 weeks after the last dose. Male patients with female partners of reproductive potential to use effective contraception during the study and for 4 weeks after the last dose.
- Able and willing to adhere to all protocol requirements and study procedures throughout the course of the study.
- Ability to comprehend and be informed of the nature of the study, as assessed by study clinic staff
Who cannot join
- 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.
- Patients who have not completely recovered from any toxicities from previous chemotherapy, hormone therapy, immunotherapy, target therapy, or radiotherapies ≥ Grade 1 per NCI CTCAE version 5.0, with the exception of alopecia.
- Patients who have received any of the following treatments within the specified timeframes prior to screening:
- Prior chemotherapy within 30 days prior to screening (42 days for mitomycin C or nitrosoureas).
- Prior immunotherapy, prior anti-tumor hormonal therapy (for breast cancer patients), and prior radiotherapy within 30 days prior to screening.
- Radiotherapy is not allowed during study. Administration of other chemotherapy, immunotherapy, or anti-tumor hormonal therapy during the study is not allowed.
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- Patients had major surgery within 30 days prior to randomization, or patients have not recovered from prior major surgery.
- Sensory / Peripheral neuropathy of > Grade 1 per NCI CTCAE version 5.0 at Screening.
- 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.
- 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).
- History of difficulty with donating blood or difficulty in accessibility of central line.
- Known history or presence of:
- Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C (serology to confirm absence is required within 7 days prior to randomization and assessed based on local labs);
- Alcohol abuse or dependence within one year prior to randomization;
- Drug abuse or dependence (marijuana, amphetamines, barbiturates, cocaine, opiates and benzodiazepines);
- Hypersensitivity or idiosyncratic reaction to everolimus, other rapamycin derivatives or its excipients
- Severe allergic reactions (e.g., anaphylactic reactions, angioedema).
- Patients may not participate in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or the use of investigational devices with therapeutic intent within 30 days prior to randomization and while enrolled in this study. Caution is recommended when administering Sapu003 and concomitantly with known substrates, PgP inhibitors, inhibitors, and inducers of the cytochrome P450 isoenzymes CYP2C8 and CYP3A4.
- Use of any strong inhibitors of cytochrome P450 (CYP) enzymes (e.g., fluoxetine, quinidine, erythromycin, ciprofloxacin, fluconazole, ketoconazole, diltiazem and HIV antivirals) and strong inducers of CYP enzymes (e.g., barbiturates (phenobarbital), carbamazepine, phenytoin and rifampin), in the previous 14 days before randomization until the last blood draw in the study.
- Acute active infection requiring antibiotics, antiviral agents, or antifungal agents within 14 days prior to randomization
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
SOCRU
Adelaide
Sud Agarwal, 1300 030 380, dr.sudhanshu@ingenucro.com
About this study
Official title: A Phase 1b, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics of Sapu003 in Advanced mTOR-sensitive Solid Tumors (With or Without Exemestane)
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]).
Read the detailed description
The study will include two cohorts:
- Cohort A: Patients with HR+/HER2-negative breast cancer who will receive Sapu003 in combination with exemestane.
- Cohort B: Patients with RCC, NETs, TSC-associated tumors, or HCC who will receive Sapu003 without exemestane.
The dose levels planned for this study are 5 mg/m², 7.5 mg/m², and 10 mg/m² administered as weekly 30-minute IV infusions, with each treatment cycle lasting 4 weeks (28 days).
The primary purpose of this study is to determine the maximum tolerated dose (MTD) of weekly intravenous Sapu003. Secondary objectives include characterizing the pharmacokinetic profile of Sapu003, evaluating its safety and tolerability, and assessing preliminary antitumor activity.
- Conditions
- Breast Cancer Metastatic, Renal Cell Carcinoma (RCC), Neuroendocrine Tumors, Tuberous Sclerosis Complex (TSC), Hepatocellular Carcinoma (HCC)
- Being tested
- Sapu003, Exemestane 25 MG
- Keywords
- Sapu003, Everolimus for Injection, mTOR-Sensitive Solid Tumors, Renal Cell Carcinoma (RCC), Neuroendocrine Tumors (NETs), Tuberous Sclerosis Complex (TSC), Hepatocellular Carcinoma (HCC), everolimus, HR+/HER2-negative breast cancer
- Medical subject headings
- Carcinoma, Renal Cell, Neuroendocrine Tumors, Tuberous Sclerosis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sapu003Drug
Also called Sapu003/Everolimus for Injection
Sapu003 weekly IV at 5, 7.5 or 10 mg/m²
Exemestane 25 MGDrug
Also called Exemestane
Exemestane 25 mg QD (Breast Cancer Only)
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - HR+/HER2- Breast Cancer | Experimental | Cohort A (Combination Therapy - HR+/HER2- Breast Cancer):
Post-menopausal women with advanced or metastatic hormone-receptor-positive, HER2-negative breast cancer receive Sapu003 (everolimus for injection) as a 30-min IV infusion once weekly at 5, 7.5 or 10 mg/m², together with oral exemestane 25 mg once daily, repeated in 28-day cycles. Receives: Drug: Sapu003; Drug: Exemestane 25 MG |
| Cohort B - RCC / NET / TSC / HCC | Experimental | Cohort B (Monotherapy - RCC / NET / TSC / HCC):
Adult patients with advanced renal cell carcinoma, neuro-endocrine tumours, tuberous-sclerosis-complex-associated tumours, or hepatocellular carcinoma receive Sapu003 (everolimus for injection) alone as a 30-min infusion once weekly at 5, 7.5 or 10 mg/m², repeated in 28-day cycles. Receives: Drug: Sapu003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) and Dose Limiting Toxicities (DLTs) of Sapu003 in Patients with Advanced mTOR-Sensitive Solid Tumors
The primary outcome of the study is to determine the Maximum Tolerated Dose (MTD) of Sapu003, defined as the dose level where the estimated true probability of Dose-Limiting Toxicity (DLT) is closest to the target toxicity probability (TTP) of 0.27. This will be evaluated through a dose-escalation design, where patients receive Sapu003 intravenously every week, with doses ranging from 5 to 10 mg/m². The analysis will include the cumulative number of DLTs observed at each dose level, guiding decisions for dose escalation or de-escalation, ultimately reporting the recommended MTD based on isotonic regression estimates
Measured: 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
Secondary outcomes (12)
Pharmacokinetic Endpoint - Cmax
Characterization of the Pharmacokinetic Endpoint - Peak Plasma Concentration (Cmax)
Measured: Week 1 of Cycle 1 and Cycle 2 (28 days per Treatment Cycle)
Pharmacokinetic Endpoint - AUClast
Characterization of the Pharmacokinetic Endpoint - Area Under the Curve from time zero to the last quantifiable concentration (AUClast)
Measured: Week 1 of Cycle 1 and Cycle 2 (28 days per Treatment Cycle)
Pharmacokinetic Endpoint - AUCinf
Characterization of the Pharmacokinetic Endpoint - Area Under the Curve to Infinity (AUCinf)
Measured: Week 1 of Cycle 1 and Cycle 2 (28 days per Treatment Cycle)
Pharmacokinetic Endpoint - tmax
Characterization of the Pharmacokinetic Endpoint - Time to reach maximum concentration (tmax)
Measured: Week 1 of Cycle 1 and Cycle 2 (28 days per Treatment Cycle)
Characterization of the Pharmacokinetic Endpoint - t1/2
Characterization of the Pharmacokinetic Endpoint - Elimination half-life (t1/2)
Measured: Week 1 of Cycle 1 and Cycle 2 (28 days per Treatment Cycle)
Pharmacokinetic Endpoint - CL
Characterization of the Pharmacokinetic Endpoint - Clearance (CL)
Measured: Week 1 of Cycle 1 and Cycle 2 (28 days per Treatment Cycle)
Pharmacokinetic Endpoint - Vd
Characterization of the Pharmacokinetic Endpoint - Volume of Distribution (Vd)
Measured: Week 1 of Cycle 1 and Cycle 2 (28 days per Treatment Cycle)
Anti-Tumor Activity Assessment - ORR
Preliminary anti-tumor activity - ORR (Objective Response Rate)
Measured: Through study completion
Anti-Tumor Activity Assessment - DCR
Preliminary anti-tumor activity - DCR (Disease Control Rate)
Measured: Through study completion
Anti-Tumor Activity Assessment - PFS
Preliminary anti-tumor activity - PFS (Progression-Free Survival)
Measured: Until the end of the study
Anti-Tumor Activity Assessment - DoR
Preliminary anti-tumor activity - DoR (Duration of Response)
Measured: Until the end of the study
Anti-Tumor Activity Assessment - OS
Preliminary anti-tumor activity - OS (Overall Survival)
Measured: Until the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start15 Dec 2025
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This is a Phase 1b, open-label, sequential-assignment, dose-escalation study that uses a model-assisted Bayesian Optimal Interval (BOIN) design to guide intra-subject and inter-cohort dose decisions. Participants are enrolled in cohorts of three (with staggered "sentinel" dosing within each cohort) and receive once-weekly IV Sapu003 for four weeks per 28-day cycle. Two parallel disease-defined cohorts are studied: * Cohort A (HR+/HER2- breast cancer) - Sapu003 + daily oral exemestane * Cohort B (RCC, NETs, TSC-associated tumors, or HCC) - Sapu003 monotherapy Dose escalation proceeds from 5 mg/m² to 7.5 mg/m² to 10 mg/m² (with an optional -1 level of 3.5 mg/m²) according to BOIN escalation (λe ≈ 0.213) and de-escalation (λd ≈ 0.322) boundaries that target a DLT rate of 27 % during Cycle 1. Each dose level may expand to nine evaluable subjects; maximum sample size for the MTD determination is 27.
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SAPU NANO (US) LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369505
- Sponsor's protocol ID
- SP-03-B101
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics of Sapu003 in Advanced mTOR-sensitive Solid Tumors (With or Without Exemestane)
- ClinicalTrials.gov ID
- NCT07369505
- Acronym / sponsor ID
- SP-03-B101
- Conditions
- Breast Cancer Metastatic, Renal Cell Carcinoma (RCC), Neuroendocrine Tumors, Tuberous Sclerosis Complex (TSC), Hepatocellular Carcinoma (HCC)
- Keywords
- Sapu003, Everolimus for Injection, mTOR-Sensitive Solid Tumors, Renal Cell Carcinoma (RCC), Neuroendocrine Tumors (NETs), Tuberous Sclerosis Complex (TSC), Hepatocellular Carcinoma (HCC), everolimus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- SAPU NANO (US) LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]).
Detailed description
The study will include two cohorts:
- Cohort A: Patients with HR+/HER2-negative breast cancer who will receive Sapu003 in combination with exemestane.
- Cohort B: Patients with RCC, NETs, TSC-associated tumors, or HCC who will receive Sapu003 without exemestane.
The dose levels planned for this study are 5 mg/m², 7.5 mg/m², and 10 mg/m² administered as weekly 30-minute IV infusions, with each treatment cycle lasting 4 weeks (28 days).
The primary purpose of this study is to determine the maximum tolerated dose (MTD) of weekly intravenous Sapu003. Secondary objectives include characterizing the pharmacokinetic profile of Sapu003, evaluating its safety and tolerability, and assessing preliminary antitumor activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a Phase 1b, open-label, sequential-assignment, dose-escalation study that uses a model-assisted Bayesian Optimal Interval (BOIN) design to guide intra-subject and inter-cohort dose decisions. Participants are enrolled in cohorts of three (with staggered "sentinel" dosing within each cohort) and receive once-weekly IV Sapu003 for four weeks per 28-day cycle. Two parallel disease-defined cohorts are studied: * Cohort A (HR+/HER2- breast cancer) - Sapu003 + daily oral exemestane * Cohort B (RCC, NETs, TSC-associated tumors, or HCC) - Sapu003 monotherapy Dose escalation proceeds from 5 mg/m² to 7.5 mg/m² to 10 mg/m² (with an optional -1 level of 3.5 mg/m²) according to BOIN escalation (λe ≈ 0.213) and de-escalation (λd ≈ 0.322) boundaries that target a DLT rate of 27 % during Cycle 1. Each dose level may expand to nine evaluable subjects; maximum sample size for the MTD determination is 27.
| Arm | Type | Receives |
|---|---|---|
| Cohort A - HR+/HER2- Breast Cancer | Experimental | Drug: Sapu003, Drug: Exemestane 25 MGCohort A (Combination Therapy - HR+/HER2- Breast Cancer): Post-menopausal women with advanced or metastatic hormone-receptor-positive, HER2-negative breast cancer receive Sapu003 (everolimus for injection) as a 30-min IV infusion once weekly at 5, 7.5 or 10 mg/m², together with oral exemestane 25 mg once daily, repeated in 28-day cycles. |
| Cohort B - RCC / NET / TSC / HCC | Experimental | Drug: Sapu003Cohort B (Monotherapy - RCC / NET / TSC / HCC): Adult patients with advanced renal cell carcinoma, neuro-endocrine tumours, tuberous-sclerosis-complex-associated tumours, or hepatocellular carcinoma receive Sapu003 (everolimus for injection) alone as a 30-min infusion once weekly at 5, 7.5 or 10 mg/m², repeated in 28-day cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (35 listed)
- Sex and Age: Patients must be ≥ 18 years of age at the time of informed consent.
- Cohort A HR+/HER2- Breast Cancer:
- Cohort B Other Advanced mTOR-Sensitive Solid Tumors:
- Patients must be on stable doses of metformin or statin
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Key exclusion criteria (21 listed)
- 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.
- Patients who have not completely recovered from any toxicities from previous chemotherapy, hormone therapy, immunotherapy, target therapy, or radiotherapies ≥ Grade 1 per NCI CTCAE version 5.0, with the exception of alopecia.
- Patients who have received any of the following treatments within the specified timeframes prior to screening:
- Patients had major surgery within 30 days prior to randomization, or patients have not recovered from prior major surgery.
- Sensory / Peripheral neuropathy of > Grade 1 per NCI CTCAE version 5.0 at Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sapu003Also: Sapu003/Everolimus for InjectionSapu003 weekly IV at 5, 7.5 or 10 mg/m² | Drug | Cohort A - HR+/HER2- Breast Cancer, Cohort B - RCC / NET / TSC / HCC |
| Exemestane 25 MGAlso: ExemestaneExemestane 25 mg QD (Breast Cancer Only) | Drug | Cohort A - HR+/HER2- Breast Cancer |
Primary outcome
Maximum Tolerated Dose (MTD) and Dose Limiting Toxicities (DLTs) of Sapu003 in Patients with Advanced mTOR-Sensitive Solid Tumors
Time frame: 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
The primary outcome of the study is to determine the Maximum Tolerated Dose (MTD) of Sapu003, defined as the dose level where the estimated true probability of Dose-Limiting Toxicity (DLT) is closest to the target toxicity probability (TTP) of 0.27. This will be evaluated through a dose-escalation design, where patients receive Sapu003 intravenously every week, with doses ranging from 5 to 10 mg/m². The analysis will include the cumulative number of DLTs observed at each dose level, guiding decisions for dose escalation or de-escalation, ultimately reporting the recommended MTD based on isotonic regression estimates
12 secondary outcomes
Pharmacokinetic Endpoint - Cmax
Time frame: Week 1 of Cycle 1 and Cycle 2 (28 days per Treatment Cycle)
Pharmacokinetic Endpoint - AUClast
Time frame: Week 1 of Cycle 1 and Cycle 2 (28 days per Treatment Cycle)
Pharmacokinetic Endpoint - AUCinf
Time frame: Week 1 of Cycle 1 and Cycle 2 (28 days per Treatment Cycle)
Pharmacokinetic Endpoint - tmax
Time frame: Week 1 of Cycle 1 and Cycle 2 (28 days per Treatment Cycle)
Characterization of the Pharmacokinetic Endpoint - t1/2
Time frame: Week 1 of Cycle 1 and Cycle 2 (28 days per Treatment Cycle)
Pharmacokinetic Endpoint - CL
Time frame: Week 1 of Cycle 1 and Cycle 2 (28 days per Treatment Cycle)
Pharmacokinetic Endpoint - Vd
Time frame: Week 1 of Cycle 1 and Cycle 2 (28 days per Treatment Cycle)
Anti-Tumor Activity Assessment - ORR
Time frame: Through study completion
Anti-Tumor Activity Assessment - DCR
Time frame: Through study completion
Anti-Tumor Activity Assessment - PFS
Time frame: Until the end of the study
Anti-Tumor Activity Assessment - DoR
Time frame: Until the end of the study
Anti-Tumor Activity Assessment - OS
Time frame: Until the end of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sapu003 and Exemestane 25 MG in people with Breast Cancer Metastatic and Renal Cell Carcinoma (RCC), run by SAPU NANO (US) LLC at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 35 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Lee ((650) 635-7024, cynthia.lee@sapunano.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) and Dose Limiting Toxicities (DLTs) of Sapu003 in Patients with Advanced mTOR-Sensitive Solid Tumors (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.