ANZCTR - Registration

Registration number

ACTRN12626001340325p

Ethics application status

Submitted, not yet approved

Date submitted

19/10/2026

Date registered

6/11/2026

Date last updated

6/11/2026

Date data sharing statement initially provided

6/11/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

A Phase 1b, Open-Label Dose-Escalation Study of Sapu006 in Patients with Advanced Solid Tumors Selected by Baseline Serum Albumin, with Exploratory Tumor Albumin (ALB) RNA Profiling

Scientific title

A Phase 1b, Open-Label Dose-Escalation Study of Sapu006 in Patients with Advanced Solid Tumors Selected by Baseline Serum Albumin, with Exploratory Tumor ALB RNA Profiling

Additional trial identifiers [1]

SP-06-O102

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Cancer

Condition category

Condition code

Cancer

Prostate

Cancer

Ovarian and primary peritoneal

Cancer

Breast

Cancer

Lung - Non small cell

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

SAPU006 (a polymer-based, solvent-free nanoparticle formulation of docetaxel) is given as an intravenous infusion over 60 minutes (±5 minutes) on Day 1 of each 21-day cycle (every 3 weeks). Participants are enrolled into 2 cohorts.

In Cohort 1, participants with metastatic breast cancer or non-small cell lung cancer receive SAPU006 alone, and participants with metastatic castration-resistant prostate cancer receive SAPU006 plus oral prednisone.

In Cohort 2, participants with metastatic epithelial ovarian, fallopian tube or primary peritoneal cancer receive SAPU006 plus carboplatin. Carboplatin is dosed to AUC 5 mg·min/mL using the Calvert formula and given as a 30-minute intravenous infusion straight after the SAPU006 infusion.

Cohort allocation is based only on cancer type. Both cohorts open at the same time and enrol and dose participants in parallel. Cohort 2 does not wait for Cohort 1 to finish.

Tumour albumin (ALB) RNA profiling is exploratory. It does not determine which cohort a participant enters or what dose they receive. To be eligible, participants must have a baseline serum albumin of at least 4.0 g/dL, measured within 7 days before the first dose, and must provide a suitable tumour sample. During screening (within 28 days before the first dose of SAPU006), the site obtains a previously collected (archival) tumour sample. This should preferably be the most recent sample, ideally taken after the participant’s last systemic treatment or at progression. The sample can be a formalin-fixed paraffin-embedded block, unstained slides with an H&E slide, or frozen tissue. Wherever feasible, it is sent to a central laboratory before the first dose, where RNA sequencing measures ALB gene expression in the tumour. For most participants this involves no extra procedure. If suitable archival tissue is not available, a fresh needle biopsy may be taken during screening, before the first dose. This is done only if the investigator considers it safe and clinically feasible, and only with separate consent for the procedure. Results are not used to make treatment decisions. Instead, they are analysed to explore whether tumour ALB expression, together with baseline serum albumin, is associated with pharmacokinetics, tumour response and survival. Samples are used only for this study and are then destroyed.

This is an open-label dose-escalation study using a Bayesian Optimal Interval (BOIN) design. Each cohort follows its own independent BOIN scheme, run in parallel, with the same dose levels and the same decision rules.
SAPU006 is tested at 3 dose levels: 60 mg/m² (starting dose in both cohorts), 75 mg/m² and 100 mg/m². A de-escalation dose of 55 mg/m² is used if 60 mg/m² is not tolerated. This dose is given to a fixed group of 6 participants, and if it is not tolerated the study stops. Participants are enrolled at each dose level in groups of 3, with up to 9 per dose level and a maximum of 27 in total. After each group completes Cycle 1, the BOIN rule is applied within that cohort, using a target DLT rate of 27%. If 21.3% or fewer of the evaluable participants at the current dose have a DLT, the dose is escalated. If more than 32.2% have a DLT, the dose is de-escalated. Otherwise the dose stays the same. A dose level is closed if at least 3 of 3, 4 of 6, or 5 of 9 participants have a DLT, and higher doses are then not tested.

In Cohort 2, haematological DLTs count against SAPU006 because both SAPU006 and carboplatin can suppress the bone marrow. A Safety Review Committee reviews all accumulated safety data before each new group is enrolled. Because the cohorts escalate independently, they may be at different dose levels at any time, and a separate maximum tolerated dose is determined for each cohort. Up to 2 dose reductions are allowed for toxicity. SAPU006 is given in hospital by site staff using non-PVC/non-DEHP infusion bags and sets with a 0.2 micron in-line filter. For the first 10 minutes it runs at no more than 1 mg/minute, then the rate is increased so the infusion finishes within 1 hour.

Before each infusion, participants receive an antihistamine and a corticosteroid. The standard antihistamine is diphenhydramine 25–50 mg intravenously, given so that it is completed about 30 minutes before the infusion. At the investigator’s discretion, cetirizine 10 mg orally may be given instead as an equivalent alternative, taken at least 60 minutes before the infusion. The corticosteroid is hydrocortisone 100 mg intravenously or methylprednisolone 20 mg intravenously, chosen by the investigator, and is completed about 30 minutes before the infusion.

Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent or the investigator decides to stop. Participants are withdrawn if treatment is held for more than 3 weeks, unless the investigator judges that continuing at a reduced dose is in their best interest. Adherence is ensured because every infusion is given and directly observed by qualified site staff, with the dose, date and time of each infusion recorded. The site pharmacy keeps drug accountability logs for every unit dispensed, following the study pharmacy manual.

Intervention code [1]

Treatment: Drugs

Description of the comparator or control

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Maximum tolerated dose of SAPU006 in Cohort 1 (SAPU006 alone in metastatic breast cancer and non-small cell lung cancer, and SAPU006 plus prednisone in metastatic castration-resistant prostate cancer)

Timepoint [1]

Baseline (screening), weekly during Cycle 1, and end of Cycle 1 (Day 21 after the first dose of SAPU006)

Primary outcome [2]

Maximum tolerated dose of SAPU006 in combination with carboplatin in Cohort 2 (metastatic epithelial ovarian, fallopian tube or primary peritoneal cancer)

Timepoint [2]

Baseline (screening); Cycle 1 Day 1 (before dosing and at the end of the SAPU006 infusion for vital signs); weekly during Cycle 1 for laboratory tests; and the end of Cycle 1 (Day 21 after the first dose of SAPU006). This 21-day window is the DLT assessment period.

Secondary outcome [1]

Incidence of dose-limiting toxicities

Timepoint [1]

Baseline (screening), weekly during Cycle 1, and end of Cycle 1 (Day 21 after the first dose of SAPU006)

Secondary outcome [2]

Incidence of adverse events (e.g. neutropenia, peripheral neuropathy, infusion-related reactions, fluid retention)

Timepoint [2]

Baseline (screening), then weekly during Cycles 1 and 2 (blood tests only), Day 1 of each 21-day cycle before dosing. On Day 1 of Cycles 1 and 2, the 12-lead electrocardiogram is done within 1 hour before dosing and again within 24 hours after the end of the infusion. Assessments are also done at the end-of-treatment visit, which takes place when the participant stops SAPU006 because of disease progression, unacceptable toxicity, withdrawal of consent, or an investigator decision to stop. There is no fixed maximum treatment duration, so this timing varies between participants, but treatment cannot continue beyond study closure, 24 months after the last participant is enrolled. Adverse events are recorded from the first dose of SAPU006 until 30 days after the last dose of SAPU006 or the end-of-treatment visit, whichever is later.

Secondary outcome [3]

Pharmacokinetic profile of SAPU006

Timepoint [3]

Day 1 of Cycle 1 and Day 1 of Cycle 2: pre-dose 30, 40 and 50 minutes into the infusion end of infusion 5, 10, 20 and 30 minutes and 1, 2, 3, 6, 8, 12, 24 and 48 hours after the end of infusion

Secondary outcome [4]

Incidence of serious adverse events

Timepoint [4]

Continuously from the first dose of SAPU006 to 30 days after the last dose (or end of treatment, whichever is later). The end-of-treatment visit takes place when the participant stops SAPU006 because of disease progression, unacceptable toxicity, withdrawal of consent, or an investigator decision to stop. There is no fixed maximum treatment duration, so this timing varies between participants, but treatment cannot continue beyond study closure, 24 months after the last participant is enrolled. Serious adverse events that are ongoing at the end of this period are followed until they resolve or stabilise.

Secondary outcome [5]

Objective response rate (proportion of participants with measurable disease who have a confirmed complete or partial response)

Timepoint [5]

Baseline (within 28 days before the first dose), every 12 weeks during treatment, and at end of treatment which takes place when the participant stops SAPU006 because of disease progression, unacceptable toxicity, withdrawal of consent, or an investigator decision to stop. There is no fixed maximum treatment duration, so this timing varies between participants, but treatment cannot continue beyond study closure, 24 months after the last participant is enrolled. Adverse events are recorded from the first dose of SAPU006 until 30 days after the last dose of SAPU006 or the end-of-treatment visit, whichever is later.

Secondary outcome [6]

Duration of response

Timepoint [6]

Baseline (within 28 days before the first dose), every 12 weeks during treatment, and at end of treatment which takes place when the participant stops SAPU006 because of disease progression, unacceptable toxicity, withdrawal of consent, or an investigator decision to stop. There is no fixed maximum treatment duration, so this timing varies between participants, but treatment cannot continue beyond study closure, 24 months after the last participant is enrolled. Adverse events are recorded from the first dose of SAPU006 until 30 days after the last dose of SAPU006 or the end-of-treatment visit, whichever is later.

Secondary outcome [7]

Progression-free survival

Timepoint [7]

Baseline (within 28 days before the first dose), every 12 weeks during treatment, and at end of treatment which takes place when the participant stops SAPU006 because of disease progression, unacceptable toxicity, withdrawal of consent, or an investigator decision to stop. There is no fixed maximum treatment duration, so this timing varies between participants, but treatment cannot continue beyond study closure, 24 months after the last participant is enrolled. Adverse events are recorded from the first dose of SAPU006 until 30 days after the last dose of SAPU006 or the end-of-treatment visit, whichever is later.

Secondary outcome [8]

Overall survival

Timepoint [8]

From the first dose until death or study close (24 months after the last participant is enrolled), with phone contact every 12 weeks after disease progression

Eligibility

Key inclusion criteria

Each subject must meet all the following criteria:
1. Age: Patients must be more than or equal to 18 years of age at the time of informed consent.
2. Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
3. Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
4. Life Expectancy: more than or equal to 3 months.
5. Adequate Hematopoietic, Renal and Liver function defined as the following:
Bone Marrow Function:
o Absolute neutrophil count (ANC) more than or equal to 1,500/µL.
o Platelets more than or equal to 100,000/µL.
o Hemoglobin more than 9.0 g/dl
Renal Function:
o Serum Creatinine equals 1.5 × ULN.
Hepatic Function:
o Total Bilirubin equals ULN;
o AST/ALT equals 1.5 × ULN
o Alkaline phosphatase equals 2.5 × ULN).
6. Prothrombin time, international normalized ratio or activated partial thromboplastin time less than 1.5 × ULN; Use of full dose anticoagulants is permitted. These laboratories should be maintained within the therapeutic range and closely monitored by the Investigator.
7. Serum albumin equals 4.0 g/dL (equals 40 g/L), measured within 7 days before the first dose of protocol treatment. The qualifying specimen must be collected prior to the first dose of protocol treatment, and the patient must not have received intravenous albumin within 14 days prior to specimen collection.
8. Availability and submission of an adequate pretreatment tumor specimen suitable for RNA extraction and sequencing. Acceptable material includes an archival or fresh formalin-fixed paraffin-embedded (FFPE) tumor block (preferred), unstained FFPE slides/sections with an accompanying hematoxylin and eosin-stained slide, or appropriately preserved frozen tumor tissue, in accordance with the central laboratory manual.
9. Patients must meet the following prior treatment washout requirements before enrollment:
o Completion of prior chemotherapy at least 14 days before enrollment (42 days for mitomycin C or nitrosoureas).
o Completion of prior immunotherapy, anti-tumor hormonal therapy, and radiotherapy at least 14 days before enrollment.
o Patients must agree not to receive radiotherapy, chemotherapy, immunotherapy, or anti-tumor hormonal therapy during the study.
o Patients who have not undergone bilateral orchiectomy must continue maintenance androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist or antagonist throughout study treatment to maintain castrate serum testosterone levels (less than 50 ng/dL). Maintenance ADT is permitted and is exempt from the hormonal-treatment washout and concomitant-treatment restrictions in this protocol.
10. In case of female patient, the serum pregnancy test at screening visit and urine pregnancy test at baseline must be negative.
11. Sexually active women, unless surgically sterile (at least 6 months prior to Study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] sexual partner) for at least 1 month prior to study drug administration, during study and up to 6 months after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. Hormonal contraception alone is not permitted.
12. In case of male patients: either partner or patient must use an effective method of avoiding pregnancy for at least 1 month prior to study drug administration, during study and up to 3 months after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.
Specific Inclusion Criteria
Cohort 1: mCRPC, Metastatic Breast Cancer or NSCLC
13. mCRPC:
o Male patients with histologically confirmed adenocarcinoma of the prostate.
o Castrate levels of testosterone (less than 50 ng/dL).
o Evidence of progression (PSA or radiographic) despite androgen deprivation therapy.
o Patients who have not undergone bilateral orchiectomy must continue maintenance androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist or antagonist throughout study treatment to maintain castrate serum testosterone levels (less than 50 ng/dL). Maintenance ADT is permitted and is exempt from the hormonal-treatment washout and concomitant-treatment restrictions in this protocol.
14. Breast Cancer: Histologically confirmed locally advanced or metastatic breast cancer. Must have progressed on or after prior chemotherapy.
15. NSCLC: Histologically/cytologically confirmed advanced unresectable or metastatic NSCLC which has progressed on or after a prior line of platinum-based chemotherapy.
Cohort 2: Metastatic Ovarian Cancer
16. Histologically confirmed epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
17. No more than 2 prior lines of chemotherapy (Prior adjuvant/neoadjuvant permitted if more than 6 months ago).

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Healthy volunteers

No

Key exclusion criteria

1. Hypersensitivity or idiosyncratic reaction to docetaxel, and/or related substances including alcohol, paclitaxel, dexamethasone and antiemetic (Granisetron or Ondansetron).
2. Severe cardiovascular disease, including CVA, TIA, myocardial infarction, or unstable angina within 6 months of study entry; NYHA class III or IV heart failure within 6 months of study entry; uncontrolled arrhythmia within 6 months of study entry.
3. Average corrected QT (QTc) interval by Frederica's formula (QTcF) on triplicate ECGs at screening more than 470 msec (females) or more than 450 msec (males); or on concomitant medications that would prolong the QT interval; or have family history of long QT syndrome.
4. Patients with an active infection (e.g. tuberculosis, sepsis and opportunistic infections).
5. A qualifying serum albumin measurement obtained during an acute infection, hospitalization, major fluid imbalance, uncontrolled hepatic disease, nephrotic-range protein loss, or clinically significant ascites is not acceptable for eligibility. The patient may be rescreened after the condition has resolved or stabilized, provided all eligibility criteria and screening windows are met.
6. Patients with severe pleural effusion (volume involving > 40% of the hemithorax on CT scan chest) or gross ascites (more than 800ml of ascitic fluid).
7. Peripheral neuropathy more than or equal to grade 2 (as per CTCAE v6.0 criteria).
8. A positive hepatitis screen including hepatitis B surface antigen and HCV.
9. Patients with HIV infection.
10. Patients with known brain metastasis or those showing neurologic symptoms due to brain metastasis.
11. Recent or clinically significant history of drug or alcohol abuse.
12. Patients require concomitant treatment with potent Cytochrome P450 3A4 inhibitors, inducers or substrates.
13. Use of any Cytochrome P450 3A4 inducers, inhibitors, or substrates that may alter docetaxel metabolism (e.g. dronedarone, epirubicin, sorafenib, CNS depressants) within 14 days before enrollment until the last PK blood draw in the study.
14. Major surgery within 4 weeks prior to study entry; minor surgery within 2 weeks prior to study entry.
15. Active or untreated CNS metastases. Patients with treated CNS (brain) metastases are eligible provided they have no evidence of active brain disease and are off of definitive therapy (including steroids) at least 1 month prior to first dose.
16. The receipt of an investigational medicinal product or participation in other drug research study within a period of 30 days (or 5 half-lives, whichever is longer) prior to the first dose of investigational medicinal product for the current study.
17. Pregnant or Breast feeding female.
18. Donation of blood (1 unit or 350 ml) within 90 days prior to receiving the first dose of investigational medicinal product for the current study.
19. Abnormal baseline laboratory / physical findings considered to be clinically significant by the investigator.
20. Patients with any significant history of non-compliance or inability to reliably grant informed consent.
21. Uncontrolled intercurrent illness (infection, cardiac arrhythmia).
22. Concomitant Medications and Supplements:
o Currently receiving any other investigational agents.
o Initiation of bisphosphonate therapy immediately prior to or during the study. (Patients on a stable dose prior to enrollment may continue).
o Use of herbal, alternative, or food supplements (e.g., PC-Spes, Saw Palmetto, St. John's Wort). (Standard multivitamins, Vitamin D, and calcium are permitted).
o Receiving combination anti-retroviral therapy for HIV.
23. For Cohort 2 only: History of severe hypersensitivity to platinum-containing compounds.
24. Patients are also excluded if they require or are currently receiving:
o Enrollment in any other clinical protocol or investigational trial involving treatment.
o Irradiation (radiation therapy) during the study.
o Any chemotherapy, immunotherapy, or antitumor hormonal therapy other than that specified in the study protocol.

Study design

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/12/2026

Actual

Date of last participant enrolment

Anticipated

1/12/2027

Actual

Date of last data collection

Anticipated

1/12/2029

Actual

Sample size

Target

27

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Sapu Nano (US) LLC

Country [1]

United States of America

Primary sponsor type

Commercial sector/Industry

Name

Sapu Nano (US) LLC

Country

United States of America

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Clinical Trials AUS LSA Pty Ltd (t/a iNGENu CRO)

Country [1]

Australia

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

St Vincent’s Hospital Human Research Ethics Committee

Ethics committee address [1]

https://svhs.org.au/home/research-education/research-office

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/11/2026

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

This study aims to find the highest dose of an investigational drug called Sapu006 that can be given safely. Sapu006 is a new form of the chemotherapy drug docetaxel. It packs docetaxel into tiny particles so it doesn’t need to be dissolved in a solvent, which may cause side effects in some patients. Laboratory studies suggest Sapu006 behaves in the body much like standard docetaxel. This study will check its safety and measure how the body handles it. The study will also look at whether the amount of a protein called albumin in the blood and in the tumour is linked to how well the treatment works.

Who is it for?
You may be eligible for this study if you are an adult aged 18 years or older with one of the following conditions:

locally advanced or metastatic breast cancer that has grown after previous chemotherapy
advanced or metastatic non-small cell lung cancer that cannot be removed by surgery and has grown during or after platinum-based chemotherapy
metastatic castration-resistant prostate cancer
metastatic epithelial ovarian, fallopian tube or primary peritoneal cancer, with no more than 2 previous lines of chemotherapy.

You will also need a blood albumin level of at least 4.0 g/dL and a suitable sample of your tumour. A study doctor will do health checks to confirm whether you can take part.

Study details
All participants will receive Sapu006 as a 1-hour infusion into a vein once every 3 weeks. Before each infusion, participants will receive medicines to help prevent allergic reactions. Depending on the type of cancer you have, you may also receive a second, approved cancer medicine that is commonly given with docetaxel:

Participants with breast cancer or non-small cell lung cancer will receive Sapu006 alone.
Participants with prostate cancer will also take prednisone tablets.
Participants with ovarian, fallopian tube or primary peritoneal cancer will also receive an infusion of carboplatin (another chemotherapy drug) straight after the Sapu006 infusion.

The first participants will receive a low dose of Sapu006. A safety committee will review the results for each small group of participants before higher doses are given, and the dose can also be lowered if needed. Treatment can continue for as long as it is helping and the side effects are manageable.

During the study, participants will have regular check-ups, blood tests and scans, and will be asked to report any side effects. In the first 2 treatment cycles, extra blood samples will be taken to measure Sapu006 levels, and participants may need to stay in hospital for up to 2 days after the infusion. A stored sample of each participant’s tumour will be tested for albumin gene activity. If no stored sample is available, a new biopsy may be taken if it is safe to do so.

It is hoped this research will identify a safe dose of Sapu006, given alone or with prednisone or carboplatin, for future trials. It will also give an early indication of whether Sapu006 can help control these cancers.

Trial website

Public notes

Contacts

Principal investigator

Name

Dr Krishna Rachakonda

Address

Mildura Base Public Hospital, PO Box 620 Mildura VIC 3502

Country

Australia

Phone

+61 3 5022 3333

Email

[email protected]

Contact person for public queries

Name

Darryl Davies

Address

iNGENu CRO, Office 5/456 St Kilda Road, Melbourne VIC 3004

Country

Australia

Phone

+61 1300030380

Email

[email protected]

Contact person for scientific queries

Name

Darryl Davies

Address

iNGENu CRO, Office 5/456 St Kilda Road, Melbourne VIC 3004

Country

Australia

Phone

+61 1300030380

Email

[email protected]

Trial Review

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