A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSapience Therapeutics
About this trial
This is an open-label, two-part, phase 1-2 study designed to determine the safety, tolerability, PK, pharmacodynamics (PD), and proof-of-concept efficacy of ST316 administered IV in subjects with selected advanced solid tumors likely to harbor abnormalities of the WNT/β-catenin signaling pathway. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able and willing to sign an informed consent form (ICF) and comply with the protocol and the restrictions and assessments therein.
Male or female ≥18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
For the dose-escalation phase: CRC, HCC, TNBC, NSCLC, OC, melanoma, CCA, and SS.
Disqualifiers
Agrees to provide a newly obtained biopsy of an accessible lesion (if they can be biopsied based on the Investigator's assessment) prior to the start of study treatment, and to repeat biopsy once during study treatment. Tissue obtained for the biopsy must not be previously irradiated, but a new or progressing lesion in the radiation field is acceptable. Subjects without accessible lesion for biopsy must be able to provide an archival tumor tissue sample for central lab analysis.
Known hypersensitivity to ST316 or any of its excipients.
Known hypersensitivity to bevacizumab, 5-FU, leucovorin or irinotecan for Cohort 2, to fruquintinib for Cohort 3 and trifluridine or tipiracil for Cohort 4 in the expansion.
Corrected interval between Q and T wave on electrocardiogram (ECG) (QTc) > 480 msec using Fredericia's formula.
Trial design
Design model
Sequential
Treatments tested in this trial
ST316
DrugIV
FOLFIRI regimen & bevacizumab
DrugFOLFIRI: Days 1 and 15 of each 28-day cycle: * irinotecan 180 mg/m2 IV over 90 minutes concurrently with * leucovorin 400 mg/m2 IV over 2 hours, and then * 5-FU bolus 400mg/m2 (up to 15 min infusion) * 5-FU 2400 mg/m2 IV over 46 hours * bevacizumab should be administered as 5mg/kg.
Fruquintinib
Drug5 mg once a day for the first 21 days of a 28-day cycle
Lonsurf & bevacizumab
DrugLonsurf 35 mg/m2 twice daily on days 1-5 and days 8-12 every 28 day bevacizumab 5 mg/kg on days 1 and 15. ST316
Treatment groups
130 Participants
are divided into 5 treatment groupsGroup A: Dose Escalation PhaseExperimental treatment 1 intervention
Group B: ST316 Monotherapy Colon Rectal Cancer (CRC) Expansion phaseExperimental treatment 1 intervention
Group C: ST316 & FOLFIRI/Bevacizumab Combination Colon Rectal Cancer (CRC) Expansion phaseExperimental treatment 2 interventions
Group D: ST316 & Fruquintinib Combination CRC Expansion phaseExperimental treatment 2 interventions
Group E: ST316 & Lonsurf + Bevacizumab Combination CRC Expansion phaseExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame
3 yearsSecondary outcomes
1
ST316 PK parameter AUCt
Area under the concentration-time curve over the dosing interval
Time frame
3 years2
ST316 Assessment DOR
DOR is defined for participants achieving a confirmed CR+PR as the time from the initial response of CR+PR per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier
Time frame
3 years3
ST316 PK parameter Cmax
Maximum observed serum concentration
Time frame
3 years4
ST316 PK parameter t1/2
half life
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov