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
Qualifiers
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
Treatments tested in this trial
- ST316
- FOLFIRI regimen & bevacizumab
- Fruquintinib
- Lonsurf & bevacizumab
Treatment groups
130 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov