Actively Recruiting
Phase I/II Clinical Study of SHR-1501 Combined With Adbelizumab in Patients With Malignant Tumors
Led by Shanghai Hengrui Pharmaceutical Co., Ltd. · Updated on 2026-01-22
203
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open, multicenter phase I/II clinical study. The entire study is divided into three stages: dose escalation, dose expansion, and efficacy expansion. Objective: To evaluate the objective response rate (ORR), safety and tolerability of the combination of SHR-1501 and adibelizumab in the treatment of advanced malignant tumors, and to provide the recommended dose (RP2D) for subsequent clinical studies.
CONDITIONS
Official Title
Phase I/II Clinical Study of SHR-1501 Combined With Adbelizumab in Patients With Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and able to sign informed consent
- Age between 18 and 75 years old
- Have locally advanced or metastatic solid tumors confirmed by biopsy and not suitable for surgery or radical chemoradiotherapy
- Disease progressed after standard treatment, no standard treatment plan, or unsuitable for standard treatment
- Have at least one measurable lesion according to RECIST 1.1
- ECOG performance status score of 0 or 1
- Expected survival time longer than 3 months
You will not qualify if you...
- Symptomatic or active central nervous system tumor metastasis
- Other malignant tumors diagnosed within five years before starting study drugs
- Uncontrolled tumor-related pain
- Severe cardiovascular or cerebrovascular diseases
- Significant bleeding symptoms within 3 months before study drugs and fresh hemoptysis within 1 month
- Uncontrollable pleural effusion or ascites or requiring intervention within 7 days before treatment
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-related pneumonia needing steroids, active pneumonia, or other moderate to severe lung diseases affecting lung function
- Severe infection within 4 weeks before treatment
- History of immunodeficiency
- Use of corticosteroids (>10 mg/day prednisone or equivalent) or systemic immunosuppressants within 14 days before study drugs
- Active pulmonary tuberculosis infection within 1 year before enrollment or untreated tuberculosis history
- Adverse events from prior treatment not recovered to Grade 1 or lower (CTCAE)
- Chemotherapy, biologic therapy, targeted therapy, immunotherapy, or other anti-tumor treatments within 4 weeks before study drugs
- Grade 3 or 4 immune-related adverse events lasting 4 weeks or longer after immune checkpoint inhibitors or leading to treatment discontinuation
- Chest radiotherapy >30 Gy within 24 weeks or non-chest radiotherapy >30 Gy within 4 weeks before study drugs
- Surgery on important organs within 4 weeks before study drugs, significant trauma, or planned elective surgery during trial
- Active or history of autoimmune diseases
- Use of live attenuated vaccines within 28 days before study drugs or planned during treatment
- Pregnant, lactating, or planning pregnancy during study and 6 months after last drug use
- Known allergy to study drug components or history of severe allergic reactions to similar drugs
- Other conditions judged by investigators to affect study safety or data collection, including alcoholism, drug abuse, serious diseases, mental illness, abnormal lab tests, or social factors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
F
Fei Qiu
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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