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
Recruiting
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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

Start date
Jun 5, 2023
Status verified
May 2025
Primary completion
May 31, 2026
Completion
May 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 ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35294
Ke Hu
[email protected]
205-644-2592
Hu
Nusrat Jahan, MD (PRINCIPAL_INVESTIGATOR)
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Stephanie Kim
[email protected]
Anthoney El-Khoueiry, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute - CODenverColorado80218
Tamara Davidson, MD
[email protected]
Jason Henry, MD (PRINCIPAL_INVESTIGATOR)
Ochsner Clinic FoundationNew OrleansLouisiana70123
Nicole Perry
Jonathan Mizrahi, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Susan Gottardt
[email protected]
617-667-2100
Bruno Bockorny, MD (PRINCIPAL_INVESTIGATOR)
START MidwestGrand RapidsMichigan49503-
Westchester Medical CenterValhallaNew York10595
Allyson Pulsoni
[email protected]
914-493-6610
Marjorie Zauderer, MD (PRINCIPAL_INVESTIGATOR)
Duke UniverstiyDurhamNorth Carolina27708
JoAnna Gontarz, MSN
[email protected]
Niharika Mettu, MD PhD (PRINCIPAL_INVESTIGATOR)
OU Health Stephenson Cancer CenterOklahoma CityOklahoma73104
Christina Caldwell
[email protected]
Susanna Ulahannan, MD (PRINCIPAL_INVESTIGATOR)
Sanford Cancer CenterSioux FallsSouth Dakota57104
Staci Vogel
[email protected]
605-312-3320
Steven Powell, MD (PRINCIPAL_INVESTIGATOR)
Fred Hutch Cancer CenterSeattleWashington98109
Erika Kalberer
[email protected]
206-606-5886
Gabriela Chiorean, MD (PRINCIPAL_INVESTIGATOR)

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