Actively Recruiting
A Dose Escalation and Dose Expansion Clinical Study of STI-7349 in Subjects With Advanced Solid Tumors
Led by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Updated on 2025-07-23
183
Participants Needed
1
Research Sites
196 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a first-in-human, Phase Ⅰ, open-label, 2-period dose escalation and expansion study of STI-7349 administered intravenously to subjects with advanced solid tumors: * Period I is divided into two parts: Dose escalation for STI-7349 alone (1A) and dose expansion for STI-7349 alone (1B). In Part 1A, a rapid titration approach and traditional 3 + 3 trial design will be used to assess the safety, dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), PK/biomarker profile, and to determine the recommended Phase 2 dose (RP2D) of STI-7349 alone; in Part 1B, an expansion study of STI-7349 alone will be conducted in target tumor types that may potentially benefit to assess the safety and preliminary efficacy of STI-7349 alone. * Period Ⅱ is divided into two parts: Dose escalation for STI-7349 in combination with Pembrolizumab (2A) or Other approved PD-1/PD-L1 inhibitors on the market (such as tislelizumab, etc.) and dose expansion for STI-7349 in combination with Pembrolizumab (2B) or Other approved PD-1/PD-L1 inhibitors on the market (such as tislelizumab, etc.). In Part 2A, a dose escalation study of STI-7349 in combination with Pembrolizumab or Other approved PD-1/PD-L1 inhibitors on the market (such as tislelizumab, etc.) is planned to be conducted using ½ RP2D of STI-7349 alone as the starting dose, which will use a traditional 3 + 3 trial design to assess the safety, DLTs, MTD, PK/biomarker profile of STI-7349 in combination with Pembrolizumab or Other approved PD-1/PD-L1 inhibitors on the market (such as tislelizumab, etc.) , and to determine the RP2D of STI-7349 in combination with Pembrolizumab or Other approved PD-1/PD-L1 inhibitors on the market (such as tislelizumab, etc.) ; in Part 2B, an expansion study of STI-7349 in combination with Pembrolizumab or Other approved PD-1/PD-L1 inhibitors on the market (such as tislelizumab, etc.) or add standard treatment on the basis of STI-7349 combined with pembrolizumab or Other approved PD-1/PD-L1 inhibitors on the market (such as tislelizumab, etc.) will be conducted in target tumor types that may potentially benefit to assess the safety and preliminary efficacy of the combination.
CONDITIONS
Official Title
A Dose Escalation and Dose Expansion Clinical Study of STI-7349 in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must understand the study and voluntarily sign informed consent.
- Age between 18 and 80 years inclusive.
- ECOG performance status score of 0 to 1.
- Expected survival of at least 12 weeks.
- At least one measurable tumor lesion by CT or MRI according to RECIST1.1 criteria.
- Confirmed malignant advanced solid tumor by histopathology or cytology, with failure or intolerance of standard treatment.
- Adequate major organ function within 7 days before first dose, including specific blood counts and liver/kidney function.
- Previous anti-tumor therapy toxicities returned to grade 1 or less, with some exceptions.
- Willingness and ability to comply with study schedule and requirements.
- Women of childbearing potential must have negative pregnancy test and use effective contraception; males must also use effective contraception.
You will not qualify if you...
- Known allergy to investigational product components or IL-2.
- Participation in another therapeutic clinical trial within 28 days prior to first dose.
- Use of immunomodulatory drugs (e.g., thymosin, IL-2, IL-15, interferon) within 14 days or 5 half-lives prior to first dose.
- Receipt of CAR-T therapy within 3 months prior to first dose; recent chemotherapy, endocrine, targeted therapy, immunotherapy, radiotherapy, or tumor embolization within specified washout periods.
- Major surgery within 28 days or minor surgery within 7 days before first dose or unhealed wounds.
- Live attenuated vaccine within 28 days prior to first dose or planned during study.
- Use of systemic immunosuppressants within 28 days prior to first dose, except certain steroids.
- Active or symptomatic central nervous system metastases or cancerous meningitis unless stable and asymptomatic.
- Uncontrolled fluid buildup requiring drainage or recent bloody effusions.
- History of other malignancies within 5 years except certain early treated cancers.
- Active autoimmune or inflammatory diseases or recent history within 2 years, with some exceptions.
- Active or uncontrolled hepatitis B, hepatitis C, or HIV infection.
- Active infections requiring intravenous antibiotics within 72 hours prior to first dose.
- Severe or uncontrolled cardiovascular or cerebrovascular diseases including recent heart attack or stroke.
- Chronic obstructive pulmonary disease with severely reduced lung function.
- Moderate or severe asthma or recent uncontrolled asthma.
- Significant pulmonary disease or active tuberculosis.
- Recent significant bleeding symptoms or gastrointestinal complications.
- Recent serious blood clotting events.
- Severe liver disease or hepatic encephalopathy.
- Known primary immunodeficiency or history of allogeneic organ transplantation (except corneal).
- Pregnant or breastfeeding women.
- Serious psychiatric or medical conditions affecting treatment or consent.
- For combination dosing subjects: allergy or prior severe adverse events to Pembrolizumab, PD-1/PD-L1 inhibitors, or standard treatments.
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
Yiwu, Zhejiang, China
Actively Recruiting
Research Team
W
Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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