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A Study of SR-8541A (ENPPI Inhibitor) in 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, an ENPP1 inhibitor, administered orally as a monotherapy in subjects with solid tumors.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-10-12
Primary completion: 2024-08-01
Study completion finish: 2024-08-01
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT06063681
Intervention or treatment
DRUG: SR-8541A
Conditions
- • Advanced / Metastatic Solid Tumor
Find a site
Closest Location:
Scientia Clinical Research Ltd
Research sites nearby
Select from list below to view details:
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
Peninsula & South Eastern Haematology & Oncology Group
Frankston, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: SR-8541A Monotherapy
| DRUG: SR-8541A
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| Frequency and severity of Adverse Events | Adverse events will be graded according to CTCAE v5.0. | 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) | From first dose of study drug through 28 days following the first dose of study treatment |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | Cmax measured in ng/mL | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | From first dose of study drug through 2 years following first dose |
Frequently Asked Questions
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