Actively Recruiting
A Phase II Clinical Trial on the Safety, Tolerability, and Efficacy 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
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, tolerability, and recommended dose of HRS-7058 combined with antitumor drugs in people with solid tumors. The study also aims to evaluate how well this combination works by measuring the objective response rate in these patients. This is a Phase II clinical trial sponsored by Shandong Suncadia Medicine Co., Ltd., focusing on adults aged 18 to 75 with measurable solid tumors. Participants will receive HRS-7058 together with antitumor drugs. The study includes monitoring for dose-limiting toxicities and adverse events during about 28 days after treatment starts. The recommended Phase II dose will be determined over approximately 12 months, with ongoing evaluation of treatment effects including response duration, disease control, progression-free survival, overall survival, drug blood levels, and antibody responses. During the study, participants will undergo various examinations, tumor tissue sampling, and regular assessments of treatment effects and side effects. Tests will include tumor measurements based on RECIST standards, blood tests for drug concentration and immune response, and monitoring for adverse events. The total participation lasts about 12 months from the first dose to the last visit, ensuring close observation of both safety and treatment outcomes.
CONDITIONS
Brief 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 study procedures
- Age between 18 and 75 years inclusive
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Provide 5-15 tumor tissue blocks or unstained tumor slices archived within 3 years or freshly obtained (not required in dose escalation phase)
- At least one measurable lesion according to RECIST v1.1
- Adequate organ function with no recent corrective treatments within 14 days before first dose
- Female participants of childbearing potential must have a negative serum pregnancy test within 7 days before first dose and agree to contraception requirements
You will not qualify if you...
- Untreated or active CNS metastases, meningeal metastasis history or presence
- Received systemic anti-tumor treatment within 28 days before enrollment
- Recent palliative radiotherapy within 14 days before first dose
- Unresolved toxicity from prior treatments above CTCAE Grade 1 excluding specific exceptions
- Use of strong CYP3A4 or P-gp/BCRP inhibitors or inducers shortly before first dose
- Active or suspected interstitial pneumonia or significant lung diseases affecting breathing
- Serious cardiovascular or cerebrovascular diseases
- Other malignant tumors unless in complete remission for at least 5 years with specific exceptions
- Severe infections recently or active infections requiring intravenous antibiotics
- Active or untreated pulmonary tuberculosis
- Active hepatitis B or C or syphilis infection
- Use or planned use of live attenuated vaccines near study treatment
- Immune deficiency diseases or history of certain transplants
- Uncontrolled fluid accumulation or severe gastrointestinal issues affecting drug absorption
- Recent significant bleeding or hemoptysis
- Recent major surgeries or non-healing wounds
- Pregnant or breastfeeding women
- Known allergies to study drugs or severe allergic history
- Uncontrolled mental illness, substance abuse, or conditions affecting study participation
- Other conditions judged by investigators to increase risk or interfere with study conduct
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - About 12 months
Participants receive HRS-7058 combined with antitumor drugs as active treatment for their solid tumors.
Visits as scheduled during treatment for dosing and assessments
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
Z
Zhengjin Zhang
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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