Actively Recruiting
A Phase 1-2 Dose-escalation and Expansion Study of ST316 in Subjects With Selected Advanced Unresectable and Metastatic Solid Tumors
Led by Sapience Therapeutics · Updated on 2025-05-11
130
Participants Needed
11
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and initial effectiveness of a drug called ST316 administered intravenously in adults with selected advanced solid tumors that may have abnormalities in the WNT/β-catenin signaling pathway. The trial is an open-label phase 1-2 study with two parts: a dose escalation and regimen exploration phase, followed by an expansion phase focused on colorectal cancer (CRC) and other advanced tumors. The study includes several treatment groups receiving different doses of ST316 once weekly, ranging from 0.5 to 12 mg/kg. In the expansion phase, participants receive ST316 alone or combined with other cancer drugs such as FOLFIRI and bevacizumab, fruquintinib, or Lonsurf and bevacizumab. Each combination targets advanced colorectal cancer in participants who have had prior treatments. Treatments are delivered by intravenous infusion on specified schedules depending on the regimen. Participants will be closely monitored throughout the study for safety using adverse event assessments and laboratory tests. Researchers will collect blood samples to study how ST316 behaves in the body and measure outcomes like overall survival, progression-free survival, and tumor response. Biopsies of accessible tumors will be obtained before and during treatment. The study duration for monitoring these outcomes is up to three years, with regular assessments to evaluate safety and treatment effects.
CONDITIONS
Brief Title
A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to sign an informed consent form and comply with study requirements
- Male or female 18 years of age or older
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Locally advanced or metastatic inoperable tumor: for dose-escalation phase includes CRC, HCC, TNBC, NSCLC, OC, melanoma, CCA, SS; for expansion phase includes CRC
- Agree to provide a newly obtained or archival biopsy of an accessible tumor lesion before and during study treatment
- Considered by the investigator to have no benefit from or be ineligible for standard therapies, or have failed or not tolerated prior anticancer treatments, with specific prior therapy limits for each study phase and cohort
You will not qualify if you...
- Known hypersensitivity to ST316 or its excipients
- Known hypersensitivity to bevacizumab, 5-FU, leucovorin, irinotecan (Cohort 2), fruquintinib (Cohort 3), or trifluridine/tipiracil (Cohort 4)
- Corrected QT interval on ECG greater than 480 msec
- Symptomatic ascites or pleural effusion unless stable for 4 weeks after treatment
- Active central nervous system metastases or carcinomatous meningitis unless stable for at least 2 weeks
- For expansion phase: any other active cancer requiring treatment besides the study disease
- For participants receiving bevacizumab-containing regimens: history of certain cardiac diseases, uncontrolled hypertension, recent arterial thrombotic events, significant vascular disease, bleeding disorders, recent major or minor surgery, significant proteinuria, recent gastrointestinal complications, ongoing serious wounds, history of reversible posterior leukoencephalopathy syndrome, or hypersensitivity to certain antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receive ST316 alone or in combination with other drugs such as FOLFIRI with bevacizumab, Fruquintinib, or Lonsurf with bevacizumab as part of their cancer treatment.
Weekly visits for ST316 dosing; additional visits as per combination regimen schedule
Duration - Up to 3 years
Participants are monitored for treatment-related adverse events and long-term outcomes such as survival and response to treatment.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 11 locations
1
University of Alabama
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
3
Sarah Cannon Research Institute - CO
Denver, Colorado, United States, 80218
Actively Recruiting
4
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70123
Actively Recruiting
5
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
6
START Midwest
Grand Rapids, Michigan, United States, 49503
Active, Not Recruiting
7
Westchester Medical Center
Valhalla, New York, United States, 10595
Actively Recruiting
8
Duke Universtiy
Durham, North Carolina, United States, 27708
Actively Recruiting
9
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
10
Sanford Cancer Center
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
11
Fred Hutch Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
J
Joyce Gakuria
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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