Actively Recruiting
Study of IMM2510 and IMM27M Combination Therapy Given by Intravenous Injection for Patients with Advanced Solid Tumors to Evaluate Safety, Tolerability, and Preliminary Antitumor Effects
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
Researchers are evaluating the safety, tolerability, effectiveness, pharmacokinetics, and pharmacodynamics of a combination therapy using IMM2510, an anti-PD-L1/VEGF bispecific antibody fusion protein, and IMM27M, a humanized Fc-engineered anti-CTLA-4 antibody, in patients with advanced solid tumors. This open-label, multi-center, single-arm phase I clinical trial includes patients with advanced malignant solid tumors who have failed or cannot tolerate standard treatments, including specific groups such as triple-negative breast cancer and advanced hepatocellular carcinoma. The study has two phases: a dose escalation phase using a 3+3 design to find the recommended dose, and a dose expansion phase involving three cohorts based on tumor type. Participants receive intravenous injections of IMM2510 and IMM27M. The dose escalation phase assesses safety and tolerability over 8 weeks, while the dose expansion phase administers the recommended dose until disease progression or treatment discontinuation, up to a maximum of 48 weeks. Throughout the study, participants undergo tumor assessments using RECIST version 1.1 criteria, and evaluations of organ function and performance status. Researchers monitor adverse events, including immune-related events, from first dose until 30 to 90 days after last dose or until starting new treatment. Safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity are closely observed. Total participation duration depends on treatment response and tolerance.
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
Q
Qiying Lu, M.D.
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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