Actively Recruiting
Phase I/II Open-label Study of HRS-6719 Evaluating Safety, Pharmacokinetics, and Preliminary Efficacy in Patients With Advanced or Metastatic Solid Tumors With MTAP Deficiency
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-05-28
120
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor effects of the drug HRS-6719 in patients with advanced or metastatic solid tumors that lack the MTAP gene. This Phase I/II, open-label, multicenter trial includes dose escalation, dose expansion, and efficacy expansion phases to better understand how the drug behaves and its potential benefits for this patient group. Participants receive HRS-6719 as the experimental treatment. The study is organized into phases that assess dose limits and tolerability during the first 21-day cycle, followed by evaluations of efficacy and recommended dosing. The trial does not include placebo controls and is open-label, meaning patients and researchers know the treatment being given. During the study, participants will be closely monitored for dose-limiting toxicities, adverse events, and other safety measures. Researchers will collect data on tumor response rates, duration of response, disease control, time to response, progression-free survival, and overall survival up to one year after treatment. The trial includes assessments of organ function, tumor tissue analysis, and other health evaluations to track the drug's effects and participant well-being throughout the study period, which may last up to several years.
CONDITIONS
Brief Title
A Phase I/II of HRS-6719 in Patients With Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent
- Age between 18 and 75 years, any gender
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Histologically or cytologically confirmed advanced malignant solid tumors with disease progression or intolerance after standard therapy, lack of standard options, or ineligibility for standard therapy
- Ability to provide sufficient fresh or archived tumor tissue samples
- Adequate vital organ function
- Use of effective contraception during the trial; negative pregnancy test within 7 days prior to first dose for women of childbearing potential
You will not qualify if you...
- History of other malignant tumors within the past 5 years
- Systemic anti-tumor therapy within 4 weeks before first study dose
- Recent surgical procedures requiring general anesthesia within 4 weeks or diagnostic/surface surgery within 1 week before first dose
- Radical radiotherapy within 4 weeks or palliative radiotherapy within 2 weeks before first dose
- Uncontrolled pleural, pericardial, or peritoneal effusions
- Severe cardiac disease within 6 months prior to first dose
- Arterial or venous thrombosis within 6 months before first dose
- Significant bleeding or bleeding risk within 3 months before first dose
- Active infection or fever above 38.5°C within 4 weeks before first dose
- History of immunodeficiency
- Active hepatitis B or C infection
- Diseases affecting drug absorption or transport
- Known or suspected severe allergic reactions to HRS-6719 or its components
- Use of strong CYP3A4/P-gp inhibitors or inducers within 5 half-lives before first dose
- Unresolved adverse events from prior anti-tumor therapy above Grade 1
- Interstitial lung disease or pneumonia requiring therapy, pulmonary fibrosis, or active pneumonia
- Active or untreated pulmonary tuberculosis within 1 year or untreated history beyond 1 year
- Live attenuated vaccines within 4 weeks before first dose or planned during study
- Other factors compromising study safety or data integrity
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 - Repeated 21-day cycles until disease progression or discontinuation
Participants receive the study drug HRS-6719 to evaluate safety, pharmacokinetics, and preliminary efficacy for advanced or metastatic solid tumors.
Visits occur throughout each 21-day treatment cycle
Duration - Up to 1 year after last dose
Participants are monitored for safety and survival outcomes after completing treatment.
Approximately 1 visit per month for 12 months
Trial Site Locations
Total: 2 locations
1
Barbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Actively Recruiting
2
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
S
Shi Wei SUN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here