Actively Recruiting
A Clinical Trial of HRS-7058 Combined Anti-tumor Drugs in Subjects With Solid Tumors
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-03-20
100
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the safety and tolerability of HRS-7058 combined with antitumor drugs in subjects with solid tumors, and to determine the recommended dosage for Phase II. Evaluate the objective response rate of HRS-7058 in combination with anti-tumor drugs in subjects with solid tumors.
CONDITIONS
Official Title
A Clinical Trial of HRS-7058 Combined Anti-tumor Drugs in Subjects With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients capable of giving informed consent and willing to comply with the study plan
- Age between 18 and 75 years old inclusive
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Expected survival of at least 12 weeks
- Provide 5-15 tumor tissue blocks fixed in formalin and embedded in paraffin or unstained tumor specimen slices from within 3 years prior to treatment or freshly obtained
- At least one measurable lesion according to RECIST v1.1 criteria
- Adequate organ function with no recent corrective treatments for blood components or cell growth factors within 14 days prior to first drug administration
- Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dose and agree to contraception requirements; must not be breastfeeding
- Male partners of female subjects of childbearing potential must agree to contraception requirements
You will not qualify if you...
- Untreated or active central nervous system metastases or history of meningeal metastasis
- Received systemic anti-tumor treatment within 28 days prior to enrollment or insufficient washout period for certain therapies
- Palliative radiotherapy completed within 14 days prior to first administration
- Unresolved toxicity from prior treatments above Grade 1 (with some exceptions)
- Use of strong CYP3A4 or P-gp, BCRP inhibitors or inducers within specified periods before first administration
- Known or suspected interstitial pneumonia or significant pulmonary diseases affecting respiratory function within 3 months prior to first administration
- Serious cardiovascular or cerebrovascular disease
- History or presence of other malignant tumors unless in complete remission for at least 5 years with some exceptions
- Severe infections within 28 days prior to first dose or active infections requiring intravenous antibiotics within 2 weeks prior to study
- Active pulmonary tuberculosis infection within 1 year or untreated past infection
- Active hepatitis B or C or active syphilis infection
- Use of live attenuated vaccines within 28 days prior to first dose or planned during treatment
- History of immune deficiency diseases or organ transplantation
- Uncontrolled third space fluid accumulation
- Conditions causing inability to swallow or absorb HRS-7058 adequately
- Significant bleeding events within 3 months or hemoptysis episodes within 1 month prior to first dose
- Major surgeries within 28 days or minor surgeries within 7 days prior to first administration; non-healing wounds or untreated fractures
- Pregnant or breastfeeding women
- Known allergies to HRS-7058 or combined antitumor drugs
- Uncontrollable mental illness, substance abuse, or conditions affecting study compliance
- Other conditions increasing risk or interfering with study participation as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
Z
Zhengjin Zhang
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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