Actively Recruiting
A Phase I/II of HRS-6719 in Patients With Advanced/Metastatic Solid Tumors
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2025-05-14
120
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase I/II, multicenter, open-label clinical trial with dose escalation/dose expansion/efficacy expansion phases, designed to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD) profiles, and antitumor efficacy characteristics of HRS-6719 in patients with MTAP-deficient advanced solid tumors.
CONDITIONS
Official 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...
- Must voluntarily agree to participate and sign informed consent
- Ages 18 to 75 years, any gender
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- 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
- Effective contraception during the trial; women of childbearing potential must have a negative pregnancy test within 7 days before first dose
You will not qualify if you...
- History of other malignant tumors within the past 5 years
- Received systemic anti-tumor therapy within 4 weeks before first dose
- Major surgery with general anesthesia within 4 weeks or diagnostic/surface surgery within 1 week prior to first dose, or planned elective surgery during the trial
- Radical radiotherapy within 4 weeks or palliative radiotherapy within 2 weeks before first dose
- Uncontrolled pleural, pericardial, or peritoneal effusions
- Severe cardiac diseases within 6 months before first dose
- Arterial or venous thrombosis within 6 months before first dose
- Significant bleeding symptoms or predisposition within 3 months before first dose
- Active infection or fever over 38.5°C within 4 weeks prior to first dose
- History of immunodeficiency
- Active hepatitis B or C infection
- Conditions 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 pneumonia or lung disease requiring hormone therapy or significant pulmonary fibrosis
- Active pulmonary tuberculosis infection within 1 year or untreated history
- Live attenuated vaccines within 4 weeks before first dose or planned during study
- Any other factors risking safety or data integrity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
S
Shi Wei SUN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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