Actively Recruiting
A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors
Led by Sapience Therapeutics · Updated on 2025-05-11
130
Participants Needed
11
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 the study protocol
- Male or female aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have a locally advanced or metastatic inoperable tumor, including colorectal cancer (CRC), hepatocellular carcinoma (HCC), triple-negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), ovarian cancer (OC), melanoma, cholangiocarcinoma (CCA), or sarcoma (SS) for dose-escalation phase; CRC for expansion phase
- Agree to provide a new biopsy of an accessible tumor lesion before treatment and once during treatment if possible, or provide archival tumor tissue if biopsy is not accessible
- Ineligible for or failed to tolerate standard therapies, or not expected to benefit from them
- For dose escalation: up to three prior lines of systemic anticancer therapies for metastatic disease allowed
- For TNBC or OC with BRCA mutations: previously treated with or intolerant to FDA-approved treatments
- For OC: treated with, refused, or ineligible for bevacizumab treatment
- For CRC with MSI-H/dMMR tumors: received, refused, or intolerant to checkpoint inhibitor therapy
- For HCC: confirmed inoperable hepatocellular carcinoma with no more than two prior lines of systemic therapy and Child Pugh Score A or B7
- For expansion cohorts, meet specific prior therapy requirements depending on assigned treatment group
You will not qualify if you...
- Known allergy to ST316 or its ingredients
- Known allergy to bevacizumab, 5-FU, leucovorin, irinotecan (for cohort 2), fruquintinib (for cohort 3), or trifluridine/tipiracil (for cohort 4)
- Prolonged QT interval on ECG (QTc > 480 msec)
- Symptomatic ascites or pleural effusion unless clinically stable for 4 weeks
- Active brain metastases or carcinomatous meningitis unless clinically stable for 2 weeks without new or growing brain lesions
- Presence of other active cancers requiring treatment besides the studied disease (expansion phase only)
- For bevacizumab regimens: history of significant heart disease, uncontrolled high blood pressure, recent thrombotic events, vascular diseases, bleeding disorders, recent major surgery, significant proteinuria, recent abdominal complications, serious wounds, or reversible posterior leukoencephalopathy syndrome
- Known allergy to Chinese hamster ovary cells or related antibodies
AI-Screening
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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
CONTACT
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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