A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors
ConditionAdvanced / Metastatic Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorStingray Therapeutics
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
SR-8541A
Drugorally administered ENPP1 inhibitor
Immune checkpoint inhibitor (ICI)
DrugThe ICI will be either nivolumab or pembrolizumab.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: SR-8541A MonotherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Frequency and severity of Adverse Events
Adverse events will be graded according to CTCAE v5.0.
Time frame
From first dose of study drug through 30 days following the last dose of study treatment2
Recommended Phase 2 Dose (RP2D) of SR-8541A
Based on evaluation of Dose Limiting Toxicities (DLT)
Time frame
From first dose of study drug through 28 days following the first dose of study treatmentSecondary outcomes
1
Maximum plasma concentration (Cmax)
Cmax measured in ng/mL
Time frame
From first dose of study drug through 28 days following the first dose of study treatment2
Area under the curve from zero up to time t (AUC0-t)
AUC0-t measured in ng.h/mL
Time frame
From first dose of study drug through 28 days following the first dose of study treatment3
Area under the concentration time curve from time 0 extrapolated to infinity (AUC0-inf)
AUC0-inf measured in ng.h/mL
Time frame
From first dose of study drug through 28 days following the first dose of study treatment4
Maximal time for peak concentration (Tmax)
Tmax measured in h
Time frame
From first dose of study drug through 28 days following the first dose of study treatmentSponsors and contacts
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Source ClinicalTrials.gov