Actively Recruiting
A Study of IMM2510 + IMM27M Combination Therapy in Patients With Advanced Solid Tumors
Led by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Updated on 2025-01-08
108
Participants Needed
1
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open-label, multi-centre, single-arm, phase I clinical study, to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of IMM2510 (an anti-PD-L1/VEGF bispecific antibody fusion protein) + IMM27M (a humanized Fc-engineered anti-CTLA-4 antibody) combination therapy in patients with advanced solid tumors.
CONDITIONS
Official Title
A Study of IMM2510 + IMM27M Combination Therapy in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the study and voluntarily sign informed consent
- Aged between 18 and 75 years, any gender
- Diagnosed with advanced malignant solid tumors confirmed by histology or cytology, failed or intolerant to previous standard treatments
- At least one evaluable or measurable tumor lesion based on RECIST version 1.1
- ECOG performance status score of 0 or 1
- Expected survival time over 3 months
- Adequate organ function including blood counts, liver, kidney, coagulation, cardiac, and thyroid functions
- For hepatocellular carcinoma patients, Child-Pugh score of 7 points or less
- Agree to use reliable contraceptive methods during the study and for at least 6 months after last treatment
You will not qualify if you...
- Received mitomycin or nitrosourea chemotherapy within 6 weeks before first dose
- Received systemic anti-tumor treatments including chemotherapy, radiotherapy, immunotherapy, or endocrine therapy within 4 weeks before first dose
- Received hormonal anti-tumor or targeted therapies within 2 weeks before first dose
- Received local radiotherapy or palliative local treatment for lesions within 2 to 4 weeks before first dose
- Received non-specific immunomodulatory treatments within 2 weeks before first dose
- Previously treated with IMM2510 or IMM27M or unable to tolerate anti-CTLA-4 or PD-1/L1 inhibitors
- Used traditional Chinese medicine with anti-tumor effects within 1 week before first dose
- Participated in other clinical trials within 4 weeks before first dose
- History of severe allergic reactions to study drugs or related antibodies
- Experienced severe immune-related adverse events or terminated prior immunotherapy due to toxicity
- Diagnosed with other cancers within past 5 years except certain cured skin or cervical cancers
- Have active second primary cancer unless investigator considers both tumors benefit from study
- Have untreated or active central nervous system tumors or unstable brain metastases
- Have uncontrolled hypertension, severe heart conditions, recent heart attack, or severe arrhythmias
- History of recent arterial or venous thrombosis
- Severe lung disease requiring oxygen or history of interstitial lung disease
- Gastrointestinal diseases causing bleeding or perforation risk
- Severe infections or active tuberculosis
- Active hepatitis B or C infections
- History of immunodeficiency or organ transplantation
- Active autoimmune diseases except controlled hypothyroidism or mild skin diseases
- Using systemic immunosuppressants or high-dose steroids within 2 weeks before enrollment
- Recent major surgery or incompletely healed wounds
- Received anti-tumor or live vaccines within 4 weeks before dosing
- History of neurological or mental disorders affecting compliance
- History of alcoholism, drug abuse, or intolerance to blood draws
- Pregnant or breastfeeding women or unwilling to use contraception
- Other investigator-determined reasons making participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
ZhongShan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
D
Deqiang Jing, M.D., Ph.D
CONTACT
Q
Qiying Lu, M.D.
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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