Actively Recruiting
Study of IMM2510 and IMM27M Combination Therapy in Patients With Advanced Solid Tumors Evaluating Safety, Pharmacokinetics, and Preliminary Efficacy
Led by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. · Updated on 2025-01-08
108
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of 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 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor efficacy of this combination therapy. The study includes patients with various advanced cancers, such as triple-negative breast cancer, hepatocellular carcinoma, and other solid tumors who have failed or are intolerant to prior treatments. The study has two phases: a dose escalation phase and a dose expansion phase. In the dose escalation phase, participants receive a single intravenous dose of IMM27M at 3.0 mg/kg on day 1, followed by IMM2510 at either 10.0 mg/kg or 20.0 mg/kg every two weeks after a 4-week interval. In the dose expansion phase, dosing is based on results from the first phase, with patients receiving IMM27M on day 1 and IMM2510 every two weeks. Treatment continues up to a maximum of 48 weeks or until disease progression or other reasons. Participants undergo regular assessments including monitoring for dose-limiting toxicities, adverse events, and immune-related adverse events. Researchers evaluate tumor response using criteria such as progression-free survival and overall survival over approximately two years. Pharmacokinetic measures like maximum concentration and half-life are collected up to one year. Safety follow-up extends up to 30 to 90 days after the last dose, and participants are closely monitored throughout the study duration, expected to last until early 2026.
CONDITIONS
Brief Title
A Study of IMM2510 + IMM27M Combination Therapy in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Able to understand and voluntarily consent to study procedures
- Diagnosed with advanced malignant solid tumors confirmed by histology or cytology
- For dose escalation: At least one evaluable tumor lesion per RECIST 1.1
- For dose expansion: At least one measurable tumor lesion per RECIST 1.1
- ECOG performance status score of 0 or 1
- Expected survival longer than 3 months
- Adequate organ function including hematological, liver, renal, coagulation, cardiac, and thyroid function as specified
- For hepatocellular carcinoma patients, Child-Pugh score of 7 or less
- Agree to use reliable contraception during the trial and for 6 months after last dose
- Voluntarily sign informed consent form
You will not qualify if you...
- Recent chemotherapy with mitomycin or nitrosourea within 6 weeks
- Systemic anti-tumor treatment within 4 weeks before study start
- Hormonal or targeted therapy within 2 weeks before study start
- Recent local radiotherapy or palliative treatment within specified intervals
- Use of non-specific immunomodulatory treatments within 2 weeks before study start
- Previous treatment with IMM2510 and/or IMM27M or intolerance to similar immune therapies
- Use of anti-tumor traditional Chinese medicine within 1 week before study
- Participation in other clinical trials within 4 weeks before study
- Severe allergy to study drug components or related antibodies
- History of significant immune-related adverse events from immunotherapy
- Other recent or active malignancies with exceptions
- Active or unstable CNS tumors or metastases except stable asymptomatic brain metastases
- Uncontrolled hypertension, significant cardiac or cerebrovascular disease
- Recent thrombotic events within 3 months
- Severe lung diseases or oxygen dependency
- Gastrointestinal conditions causing bleeding or perforation risks
- Severe active infections including tuberculosis, hepatitis B or C
- History of immunodeficiency or organ transplantation
- Active autoimmune diseases except certain controlled conditions
- Current use of immunosuppressants or systemic steroids above specified doses
- Recent major surgery or incompletely healed wounds
- Recent anti-tumor or live vaccines within 4 weeks
- History of neurological or mental disorders impacting compliance
- Recent alcoholism, drug abuse, or inability to tolerate blood draws
- Pregnancy or breastfeeding
- Other reasons determined by investigator as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks or until disease progression
Participants receive combination therapy with IMM27M and IMM2510. IMM27M is given as a single intravenous dose on Day 1, followed by IMM2510 administered intravenously every 2 weeks after a 4-week interval. Treatment continues until disease progression or other reasons for discontinuation, with a maximum duration of 48 weeks.
Visits every 2 weeks for dosing after initial 4-week interval
Duration - Up to 90 days after last dose
Participants are monitored for safety and adverse events for up to 30 days after the last dose, with extended monitoring for serious and immune-related adverse events up to 90 days, or until starting new anti-tumor treatment.
1 to 2 visits (in-person) after treatment ends
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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