Advanced / Metastatic Solid TumorPhase 1NCT06063681
A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors
A Phase 1 study testing SR-8541A and Immune checkpoint inhibitor (ICI) in people with Advanced / Metastatic Solid Tumor, run by Stingray Therapeutics at 3 sites in Australia.
Trial summary
This is an open-label, dose-escalation, multi-center phase 1 study evaluating the safety, tolerability, and pharmacokinetics (PK) of SR-8541A administered orally as a monotherapy or in combination with an immune checkpoint inhibitor (ICI) in subjects with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced / Metastatic Solid Tumor
- What is being tested?
- SR-8541A and Immune checkpoint inhibitor (ICI)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesAustralia
- Study dates
- 12 Oct 2023to Dec 2025
- 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
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
- Histopathologically/cytologically confirmed advanced solid tumor, which is refractory to standard therapeutic options, or for which there are no standard therapeutic options.
- Measurable disease per RECIST v1.1
- Willing to provide archival or fresh tumor tissue during screening (required) and post-treatment (optional)
- Adequate hematologic, renal and hepatic function
Who cannot join
- Primary central nervous system (CNS) tumor
- Prior systemic anti-cancer treatment including other investigational agents, surgery, or radiation within 28 days or 5 half-lives, whichever is less
- Continuous systemic treatment with either corticosteroids (>10 milligram [mg] daily prednisone equivalents) or other immunosuppressive medications within 28 days
- Active autoimmune disease that has required systemic treatment in past 2 years
- History of documented congestive heart failure (New York Heart Association [NYHA] class II - IV); unstable angina; poorly controlled hypertension; clinically significant valvular heart disease; high-risk uncontrolled arrhythmias (including sustained ventricular tachycardia); myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within the last 6 months, or Canadian Cardiovascular Society angina class > 2
- Troponin I > ULN
Show all 18Show fewer
- Blood pressure (BP) - Systolic < 95 mmHg or > 160 mmHg or diastolic > 100 mmHg
- Resting heart rate (HR) > 100 beats per minute (BPM)
- Corrected QT interval by Fridericia (QTcF) ≥ 470 ms
- Left Ventricular Ejection Fraction (LVEF) < 50%
- Symptomatic uncontrolled CNS disease requiring treatment with steroids or anti-seizure medications within 2 months
- Leptomeningeal disease
- Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for at least 8 weeks
- Bleeding diathesis due to underlying medical condition or anticoagulation medication which is unable to be promptly reversed by medical treatment
- Prior additional malignancy that is progressing or has received treatment the previous 3 years
- Active infection requiring systemic treatment
- Positive for human immunodeficiency virus (HIV) (HIV antibodies) or active hepatitis B (e.g., HbsAg reactive) or active hepatitis C (e.g., HCV ribonucleic acid [RNA] qualitative) infection with detectable viral load
- Major surgery within 28 days prior to Day 1 and/or minor surgery (excluding biopsy) within 7 days
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Recruiting
Monash Health
Clayton, Victoria, 3168
Amy Body
- Recruiting
Peninsula & South Eastern Haematology & Oncology Group
Frankston, Victoria, 3199
Vinod Ganju
- Recruiting
Scientia Clinical Research Ltd
Randwick, New South Wales, 2031
Charlotte Lemech
About this study
Official title: Phase 1, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study of SR-8541A (ENPP1 Inhibitor) Administered Orally as Monotherapy or in Combination With Checkpoint Inhibitors in Subjects With Advanced/Metastatic Solid Tumors
This is an open-label, dose-escalation, multi-center phase 1 study evaluating the safety, tolerability, and pharmacokinetics (PK) of SR-8541A administered orally as a monotherapy or in combination with an immune checkpoint inhibitor (ICI) in subjects with solid tumors.
Read the detailed description
SR-8541A, an ENPP1 inhibitor, will be administered orally as a monotherapy to assess safety, tolerability, and pharmacokinetics (PK) in subjects with advanced/metastatic solid tumors.
Subjects eligible for treatment include those whose disease is refractory to standard therapeutic options, or for which there are no standard therapeutic options available.
All enrolled patients will orally administer SR-8541A daily. Treatment may continue until the subject's disease worsens or another treatment discontinuation criterion is met.
The combination part will only commence once the SRC has deemed it safe to proceed and a SR-8541A dose from the dose escalation part is selected as the RP2D. The ICI will be either nivolumab or pembrolizumab and dosing will be per SOC. Both investigational products will start on C1D1. Treatment with ICI may be continued if SR-8541A is discontinued and treatment with SR-8541A may be continued after ICI is discontinued.
Approximately 10 subjects will be enrolled.
- Conditions
- Advanced / Metastatic Solid Tumor
- Being tested
- SR-8541A, Immune checkpoint inhibitor (ICI)
- Keywords
- Refractory, Relapsing, Solid Tumors
- Medical subject headings
- Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR-8541ADrug
orally administered ENPP1 inhibitor
Immune checkpoint inhibitor (ICI)Drug
The ICI will be either nivolumab or pembrolizumab.
| Study group | Role | What they receive |
|---|---|---|
| SR-8541A Monotherapy | Experimental | SR-8541A will be orally administered. Receives: Drug: SR-8541A; Drug: Immune checkpoint inhibitor (ICI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and severity of Adverse Events
Adverse events will be graded according to CTCAE v5.0.
Measured: From first dose of study drug through 30 days following the last dose of study treatment
Recommended Phase 2 Dose (RP2D) of SR-8541A
Based on evaluation of Dose Limiting Toxicities (DLT)
Measured: From first dose of study drug through 28 days following the first dose of study treatment
Secondary outcomes (11)
Maximum plasma concentration (Cmax)
Cmax measured in ng/mL
Measured: From first dose of study drug through 28 days following the first dose of study treatment
Area under the curve from zero up to time t (AUC0-t)
AUC0-t measured in ng.h/mL
Measured: From first dose of study drug through 28 days following the first dose of study treatment
Area under the concentration time curve from time 0 extrapolated to infinity (AUC0-inf)
AUC0-inf measured in ng.h/mL
Measured: From first dose of study drug through 28 days following the first dose of study treatment
Maximal time for peak concentration (Tmax)
Tmax measured in h
Measured: From first dose of study drug through 28 days following the first dose of study treatment
Terminal phase rate constant (λz)
λz measured in 1/h
Measured: From first dose of study drug through 28 days following the first dose of study treatment
Half-life (t1/2)
t1/2 measured in h
Measured: From first dose of study drug through 28 days following the first dose of study treatment
Overall Response Rate
Defined as the proportion of subjects in the efficacy population who achieve a radiographic investigator-assessed confirmed complete response (CR)/immune CR (iCR) or partial response (PR)/immune PR (iPR) per RECIST v1.1 or immune Response Evaluation Criteria in Solid Tumors (iRECIST) v1.0
Measured: From first dose of study drug through 2 years following first dose
Progression Free Survival
Defined as the time from start of treatment to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first
Measured: From first dose of study drug through 2 years following first dose
Duration of Response
Defined as the time from the date a response of PR or better was first recorded to the date on which PD was first noted or the date of death due to any cause
Measured: From first dose of study drug through 2 years following first dose
Disease Control Rate
Defined as the proportion of subjects who achieve an investigator-assessed confirmed CR/iCR, PR/iPR, or Stable Disease (SD)/immune SD (iSD) at 16 weeks per RECIST v1.1 or iRECIST v1.0
Measured: From first dose of study drug through 2 years following first dose
Overall Survival
Defined as the time from the start of treatment until death due to any cause
Measured: From first dose of study drug through 2 years following first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start12 Oct 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced / Metastatic Solid TumorStudies 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
- Not applicable
- Intervention model
- Sequential
- Model description
- The study will follow an accelerated titration dose (ATD) escalation scheme. Single-subject cohorts will open sequentially when previous cohort milestones are met, e.g. completion of the Dose-Limiting Toxicity (DLT) period. If the single evaluable subject within an ATD cohort experiences a grade ≥ 2 toxicity during the DLT period, the ATD scheme will stop and a traditional 3+3 design will be implemented. The combination part will only commence once the SRC has deemed it safe to proceed and a SR-8541A dose from the dose escalation part is selected as the RP2D. The ICI will be either nivolumab or pembrolizumab and dosing will be per SOC. Both investigational products will start on C1D1. Treatment with ICI may be continued if SR-8541A is discontinued and treatment with SR-8541A may be continued after ICI is discontinued.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stingray Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vinod Ganju, MD, Principal investigator, Peninsula & South Eastern Haematology & Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063681
- Sponsor's protocol ID
- StingrayTx
- Status last verified
- Mar 2025
- First submitted
- 23 Sep 2023
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study of SR-8541A (ENPP1 Inhibitor) Administered Orally as Monotherapy or in Combination With Checkpoint Inhibitors in Subjects With Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06063681
- Acronym / sponsor ID
- StingrayTx
- Conditions
- Advanced / Metastatic Solid Tumor
- Keywords
- Refractory, Relapsing, Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Stingray TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Oct 2023 (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 an open-label, dose-escalation, multi-center phase 1 study evaluating the safety, tolerability, and pharmacokinetics (PK) of SR-8541A administered orally as a monotherapy or in combination with an immune checkpoint inhibitor (ICI) in subjects with solid tumors.
Detailed description
SR-8541A, an ENPP1 inhibitor, will be administered orally as a monotherapy to assess safety, tolerability, and pharmacokinetics (PK) in subjects with advanced/metastatic solid tumors.
Subjects eligible for treatment include those whose disease is refractory to standard therapeutic options, or for which there are no standard therapeutic options available.
All enrolled patients will orally administer SR-8541A daily. Treatment may continue until the subject's disease worsens or another treatment discontinuation criterion is met.
The combination part will only commence once the SRC has deemed it safe to proceed and a SR-8541A dose from the dose escalation part is selected as the RP2D. The ICI will be either nivolumab or pembrolizumab and dosing will be per SOC. Both investigational products will start on C1D1. Treatment with ICI may be continued if SR-8541A is discontinued and treatment with SR-8541A may be continued after ICI is discontinued.
Approximately 10 subjects will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will follow an accelerated titration dose (ATD) escalation scheme. Single-subject cohorts will open sequentially when previous cohort milestones are met, e.g. completion of the Dose-Limiting Toxicity (DLT) period. If the single evaluable subject within an ATD cohort experiences a grade ≥ 2 toxicity during the DLT period, the ATD scheme will stop and a traditional 3+3 design will be implemented. The combination part will only commence once the SRC has deemed it safe to proceed and a SR-8541A dose from the dose escalation part is selected as the RP2D. The ICI will be either nivolumab or pembrolizumab and dosing will be per SOC. Both investigational products will start on C1D1. Treatment with ICI may be continued if SR-8541A is discontinued and treatment with SR-8541A may be continued after ICI is discontinued.
| Arm | Type | Receives |
|---|---|---|
| SR-8541A Monotherapy | Experimental | Drug: SR-8541A, Drug: Immune checkpoint inhibitor (ICI)SR-8541A will be orally administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
- Histopathologically/cytologically confirmed advanced solid tumor, which is refractory to standard therapeutic options, or for which there are no standard therapeutic options.
- Measurable disease per RECIST v1.1
- Willing to provide archival or fresh tumor tissue during screening (required) and post-treatment (optional)
Key exclusion criteria (18 listed)
- Primary central nervous system (CNS) tumor
- Prior systemic anti-cancer treatment including other investigational agents, surgery, or radiation within 28 days or 5 half-lives, whichever is less
- Continuous systemic treatment with either corticosteroids (>10 milligram [mg] daily prednisone equivalents) or other immunosuppressive medications within 28 days
- Active autoimmune disease that has required systemic treatment in past 2 years
- History of documented congestive heart failure (New York Heart Association [NYHA] class II - IV); unstable angina; poorly controlled hypertension; clinically significant valvular heart disease; high-risk uncontrolled arrhythmias (including sustained ventricular tachycardia); myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within the last 6 months, or Canadian Cardiovascular Society angina class > 2
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 |
|---|---|---|
| SR-8541Aorally administered ENPP1 inhibitor | Drug | SR-8541A Monotherapy |
| Immune checkpoint inhibitor (ICI)The ICI will be either nivolumab or pembrolizumab. | Drug | SR-8541A Monotherapy |
Primary outcome
Frequency and severity of Adverse Events
Time frame: From first dose of study drug through 30 days following the last dose of study treatment
Adverse events will be graded according to CTCAE v5.0.
Recommended Phase 2 Dose (RP2D) of SR-8541A
Time frame: From first dose of study drug through 28 days following the first dose of study treatment
Based on evaluation of Dose Limiting Toxicities (DLT)
11 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: From first dose of study drug through 28 days following the first dose of study treatment
Area under the curve from zero up to time t (AUC0-t)
Time frame: From first dose of study drug through 28 days following the first dose of study treatment
Area under the concentration time curve from time 0 extrapolated to infinity (AUC0-inf)
Time frame: From first dose of study drug through 28 days following the first dose of study treatment
Maximal time for peak concentration (Tmax)
Time frame: From first dose of study drug through 28 days following the first dose of study treatment
Terminal phase rate constant (λz)
Time frame: From first dose of study drug through 28 days following the first dose of study treatment
Half-life (t1/2)
Time frame: From first dose of study drug through 28 days following the first dose of study treatment
Overall Response Rate
Time frame: From first dose of study drug through 2 years following first dose
Progression Free Survival
Time frame: From first dose of study drug through 2 years following first dose
Duration of Response
Time frame: From first dose of study drug through 2 years following first dose
Disease Control Rate
Time frame: From first dose of study drug through 2 years following first dose
Overall Survival
Time frame: From first dose of study drug through 2 years following first dose
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 8 Jun 2025.
- 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.
Vinod Ganju, MD principal investigator
Peninsula & South Eastern Haematology & Oncology Group
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SR-8541A and Immune checkpoint inhibitor (ICI) in people with Advanced / Metastatic Solid Tumor, run by Stingray Therapeutics at 3 sites 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 6 inclusion and 18 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 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Sunil Sharma (602-343-8402, Sunil Sharma <ssharma@honorhealth.com>), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency and severity of Adverse Events (time frame: From first dose of study drug through 30 days following the last dose of study treatment). The study lists 2 primary outcomes in all. 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 8 Jun 2025.