Actively Recruiting
A Phase I Clinical Study of HRS-7058 in Patients With Advanced Malignant Tumour
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-01-21
233
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicentre, open phase I clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in subjects with advanced malignant tumour. To evaluate the safety, tolerability, pharmacokinetics and efficacy of HRS-7058.
CONDITIONS
Official Title
A Phase I Clinical Study of HRS-7058 in Patients With Advanced Malignant Tumour
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 75 years inclusive, any gender
- Locally advanced or metastatic solid tumor confirmed by histopathology
- At least one measurable lesion as per RECIST 1.1 criteria
- ECOG Performance Status of 0 or 1
- Expected survival time greater than 3 months
- Able to take oral medication and comply with study and follow-up procedures
- Adequate bone marrow and organ function
- Fertile women must agree to abstain from sex or use effective contraception from consent until last dose and have a negative blood HCG test within 7 days before treatment
- Male participants with partners of reproductive age must agree to abstain from sex or use effective contraception from consent until last dose
You will not qualify if you...
- Untreated or active central nervous system tumor metastasis
- Other malignancies within 5 years before first use of the investigational drug
- Severe cardiovascular or cerebrovascular disease
- Refractory nausea, vomiting, or gastrointestinal disorders affecting oral medication use
- Uncontrolled pleural, abdominal, or pericardial effusion
- Severe infection within 4 weeks before starting study treatment
- History of immune deficiency
- Adverse reactions from previous anti-tumor therapy not recovered to CTCAE grade 1 or less
- Antitumor therapy including chemotherapy, biotherapy, targeted therapy, immunotherapy, or investigational drugs within 4 weeks before starting study treatment
- Major organ surgery within 4 weeks before first use of study drug
- Women who are pregnant, breastfeeding, or planning pregnancy within one week after last dose
- Known allergies or contraindications to the investigational drug or its components
- Other factors judged by investigator that could affect study results or require study termination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
Y
Yifan Zhang
CONTACT
K
Keke Yan
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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