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

PHASE1RecruitingINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

June 5, 2023

Primary Completion Date

May 31, 2026

Study Completion Date

May 31, 2027

Conditions
Colon CancerMetastatic Colon Cancer
Interventions
DRUG

ST316

IV

DRUG

FOLFIRI regimen & bevacizumab

"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."

DRUG

Fruquintinib

5 mg once a day for the first 21 days of a 28-day cycle

DRUG

Lonsurf & bevacizumab

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

Trial Locations (11)

10595

RECRUITING

Westchester Medical Center, Valhalla

27708

RECRUITING

Duke Universtiy, Durham

35294

RECRUITING

University of Alabama, Birmingham

49503

ACTIVE_NOT_RECRUITING

START Midwest, Grand Rapids

57104

RECRUITING

Sanford Cancer Center, Sioux Falls

70123

RECRUITING

Ochsner Clinic Foundation, New Orleans

73104

RECRUITING

OU Health Stephenson Cancer Center, Oklahoma City

80218

RECRUITING

Sarah Cannon Research Institute - CO, Denver

90033

RECRUITING

USC Norris Comprehensive Cancer Center, Los Angeles

98109

RECRUITING

Fred Hutch Cancer Center, Seattle

02215

RECRUITING

Beth Israel Deaconess Medical Center, Boston

Sponsors
All Listed Sponsors
lead

Sapience Therapeutics

INDUSTRY

NCT05848739 - A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors | Biotech Hunter | Biotech Hunter