Actively Recruiting
A Phase II Clinical Study of HRS-7058 in Combination With Antitumor Drugs in Patients With Advanced Malignant Tumour
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-01-26
300
Participants Needed
2
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicentre, open phase II clinical study of dose escalation, dose extension and efficacy extension of HRS-7058 in combination with antitumor drugs in subjects with advanced malignant tumour. To evaluate the safety, tolerability and efficacy of HRS-7058 in combination with antitumor drugs.
CONDITIONS
Official Title
A Phase II Clinical Study of HRS-7058 in Combination With Antitumor Drugs in Patients With Advanced Malignant Tumour
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent before joining the study
- Aged between 18 and 75 years, any gender
- Diagnosed with unresectable locally advanced or metastatic solid tumor confirmed by tissue examination
- Have at least one measurable or evaluable lesion based on RECIST 1.1 criteria
- ECOG Performance Status of 0 or 1
- Expected to live longer than 12 weeks
- Able to take oral drugs and follow study and follow-up procedures
- Have adequate bone marrow and organ function
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before first study drug dose and must not be breastfeeding
- Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use contraception during the study and for specified months after last drug dose
You will not qualify if you...
- Have untreated or active central nervous system tumor metastasis
- Received antitumor therapy within 28 days before starting the study drug
- Have unresolved side effects from previous cancer treatments above grade 1
- Have known or suspected interstitial pneumonia
- Have severe heart or brain blood vessel disease
- Had other cancers within 5 years prior to starting the study drug
- Had severe infection within 28 days before starting the study drug
- Have a history of immune deficiency
- Have severe nausea, vomiting, or gut issues affecting oral drug intake
- Have uncontrolled fluid buildup in chest, abdomen, or around the heart
- Had major organ surgery within 28 days before starting the study drug
- Are pregnant or breastfeeding
- Have known allergies or contraindications to the study drug or its ingredients
- Any other conditions that the investigator believes increase risk, interfere with study results, or make participation unsuitable
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
S
Sida Zhu
CONTACT
L
Linan Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
13
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