What is STI-7349 studying for advanced solid tumors?

STI-7349 is being studied to evaluate its safety, side effects, how the drug moves in the body, and early signs of how it may affect advanced solid tumors. The study also examines STI-7349 alone and combined with Pembrolizumab or other PD-1/PD-L1 inhibitors to understand potential benefits. The Fourth Affiliated Hospital of Zhejiang University School of Medicine is leading this research.

Who may be eligible for this advanced solid tumor clinical trial?

Adults aged 18 to 80 years with advanced solid tumors who have failed or cannot tolerate standard treatments may be eligible. Participants should have a good performance status and measurable tumors, and must not have certain infections or recent immunotherapy. Both men and women can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced solid tumor clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Participants are responsible for personal travel expenses, which may vary and are not guaranteed to be covered. This helps ensure access to treatment while managing individual costs.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 80Years

All Genders

ID05978102

Open-label Phase 1 and 2 Study of STI-7349 Alone or with Pembrolizumab or Other PD-1PD-L1 Inhibitors in Adults with Advanced Solid Tumors

Led by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Updated on 2025-07-23

183

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating STI-7349, a new drug administered intravenously, in adults with advanced solid tumors who have failed or cannot tolerate standard treatments. This first-in-human Phase 1 study involves dose escalation and expansion phases to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of STI-7349 alone and in combination with Pembrolizumab or other approved PD-1PD-L1 inhibitors like Tislelizumab. The study aims to determine the recommended doses for further research and to evaluate treatment-related side effects over up to two years. The study is divided into two main periods. Period I includes dose escalation and expansion of STI-7349 alone, starting with low doses and gradually increasing following specific schedules over 21 to 28-day cycles with dosing on Day 1 and Day 15. Period II involves dose escalation and expansion of STI-7349 combined with Pembrolizumab or other approved PD-1PD-L1 inhibitors, using doses based on the results from Period I. Participants receive these combinations following similar dosing schedules and may also receive standard treatment alongside the study drugs depending on the stage of their condition. Participants will undergo regular dosing cycles lasting up to two years or until disease progression, unacceptable side effects, or withdrawal. Throughout the study, researchers will monitor safety through treatment-related adverse events, pharmacokinetic profiles including drug concentration levels, and measure tumor response using imaging techniques. Additional assessments include survival rates, disease control, and immune response markers. Participants will complete scheduled visits for drug administration and evaluations, with ongoing safety follow-up to understand the effects of the treatments.

CONDITIONS

Brief Title

A Dose Escalation and Dose Expansion Clinical Study of STI-7349 in Subjects With Advanced Solid Tumors

Who Can Participate

Age: 18Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 to 80 years inclusive
Eastern U.S. Oncology Collaborative Group (ECOG) score of 0 to 1
Expected survival of at least 12 weeks
At least one measurable tumor lesion diagnosed by CT or MRI
Diagnosis of malignant advanced solid tumors confirmed by histopathology or cytology
Failed standard treatment, cannot tolerate or obtain standard treatment, or have no standard treatment options
Major organ function within defined laboratory values prior to first dose
Previous anti-tumor therapy toxic reactions returned to grade 1 or less, with specific exceptions
Willing and able to comply with study schedule and protocol requirements
Women of childbearing potential must have negative pregnancy test and use effective contraception; men must also use effective contraception

You will not qualify if you...

Known hypersensitivity to any component of the investigational product or IL-2
Participation in any therapeutic clinical study within 28 days prior to first dose
Use of immunomodulatory drugs within 14 days or 5 half-lives before first dose
Receipt of CAR-T therapy within 3 months or recent chemotherapy, radiotherapy, or other treatments within specified timeframes
Major surgery within 28 days or minor surgery within 7 days before first dose, or unhealed wounds
Use of live attenuated vaccines within 28 days prior to first dose or planned during study
Use of systemic immunosuppressants within 28 days before first dose, with specific exceptions
Active or symptomatic central nervous system metastases or cancerous meningitis, except stable treated cases
Uncontrolled third space effusions requiring repeated drainage
Another malignancy within 5 years except certain treated early cancers
Active autoimmune or inflammatory diseases or recent history within 2 years, with exceptions
Active or uncontrolled hepatitis B, hepatitis C, or HIV infection
Active infections requiring IV antibiotics within 72 hours prior to first dose
Severe or uncontrolled cardiovascular or cerebrovascular disease
Chronic obstructive pulmonary disease with FEV1 less than 50% predicted
Moderate or severe persistent asthma or recent history of asthma within 2 years
Previous or current serious pulmonary diseases
Recent significant bleeding events or history of serious thromboembolism
Hepatic encephalopathy, hepatorenal syndrome, or severe cirrhosis
Known primary immunodeficiency or history of allogeneic organ transplantation (except corneal)
Pregnant or lactating women
Active serious psychiatric or medical conditions affecting treatment or consent
For combination dosing subjects: allergy or permanent discontinuation related to PD-1/PD-L1 inhibitors or standard treatments

Research Team

Wang

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Open-label Phase 1 and 2 Study of STI-7349 Alone or with Pembrolizumab or Other PD-1PD-L1 Inhibitors in Adults with Advanced Solid Tumors

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria