A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Sapience Therapeutics
Study ID
NCT05848739
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ST316 — DRUG
    IV
  • FOLFIRI regimen & bevacizumab — DRUG
    FOLFIRI: 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 — DRUG
    5 mg once a day for the first 21 days of a 28-day cycle
  • Lonsurf & bevacizumab — DRUG
    Lonsurf 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

Study Details

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.

Key Dates

First listed
May 8, 2023
Start date
Jun 5, 2023
Status verified
Jul 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Phase
    The dose cohorts will be 0.5, 1, 2, 4, 8 \& 12 mg/kg IV once weekly (QW)
  • Experimental: ST316 Monotherapy Colon Rectal Cancer (CRC) Expansion phase
    ST316 Monotherapy Colon Rectal Cancer (CRC) Expansion phase n=15-30
  • Experimental: ST316 & FOLFIRI/Bevacizumab Combination Colon Rectal Cancer (CRC) Expansion phase
    ST316 \& FOLFIRI/Bevacizumab Combination Colon Rectal Cancer (CRC) Expansion phase Expansion phase n=15-30
  • Experimental: ST316 & Fruquintinib Combination CRC Expansion phase
    ST316 \& Fruquintinib Combination CRC Expansion phase n=15-30
  • Experimental: ST316 & Lonsurf + Bevacizumab Combination CRC Expansion phase
    ST316 \& Lonsurf \& bevacizumab n=15-30

Primary Outcome Measure

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 3 years ]

Locations (11)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35294-
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Sarah Cannon Research Institute - CODenverColorado80218-
Ochsner Clinic FoundationNew OrleansLouisiana70123-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
START MidwestGrand RapidsMichigan49503-
Westchester Medical CenterValhallaNew York10595-
Duke UniverstiyDurhamNorth Carolina27708-
OU Health Stephenson Cancer CenterOklahoma CityOklahoma73104-
Sanford Cancer CenterSioux FallsSouth Dakota57104-
Fred Hutch Cancer CenterSeattleWashington98109-

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University of Alabama· Birmingham, ALUSC Norris Comprehensive Cancer Center· Los Angeles, CASarah Cannon Research Institute - CO· Denver, COOchsner Clinic Foundation· New Orleans, LABeth Israel Deaconess Medical Center· Boston, MASTART Midwest· Grand Rapids, MI

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