Actively Recruiting
Safety and Tolerability of CMAB017 In Patients With Advanced Solid Tumors
Led by Taizhou Mabtech Pharmaceutical Co.,Ltd · Updated on 2025-09-11
55
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-lable phase Ia clinical study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary antitumor activity of CMAB017 in advanced malignant solid tumors.
CONDITIONS
Official Title
Safety and Tolerability of CMAB017 In Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand and agree to sign the Informed Consent Form
- Histologically or cytologically confirmed inoperable, locally advanced, recurrent, or metastatic malignant solid tumors, including head and neck squamous carcinoma, RAS wild-type colorectal cancer, esophageal squamous carcinoma, etc., with failed, no, or refused standard treatment
- Age between 18 and 75 years, any gender
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Expected survival of at least 3 months
- At least one evaluable lesion according to RECIST version 1.1 (bone-only or CNS-only metastases not accepted); from 6 mg/kg Q3W or 4 mg/kg Q2W dose groups, at least one measurable lesion
- Females of childbearing potential must be non-lactating, have a negative serum pregnancy test within 1 week before first infusion, and agree to use effective contraception until 6 months after last infusion; males must agree to use contraception until 6 months after last infusion
- Blood tests during screening meet criteria: neutrophils ≥1.5x10⁹/L, platelets ≥75x10⁹/L, hemoglobin ≥90 g/L; liver enzymes ≤3x upper limit of normal (ULN) or ≤5x ULN if liver metastasis; total bilirubin ≤1.5x ULN; coagulation tests (APTT and INR) ≤1.5x ULN or within therapeutic range if on anticoagulants; renal function creatinine ≤1.5x ULN or creatinine clearance >50 mL/min if creatinine >1.5x ULN
You will not qualify if you...
- Known active central nervous system metastases or carcinomatous meningitis; previously treated brain metastases allowed if stable for at least 2 weeks, no new or growing lesions, and steroids discontinued for 2 weeks
- Grade 2 or higher corneal abnormalities at screening
- Unresolved adverse effects from prior cancer therapy above grade 1 or specified entry criteria levels (except certain low-risk toxicities)
- Other malignancies within previous 5 years except certain treated or cured cancers with disease-free status over 3 years
- History of immunodeficiency, positive HIV test, or organ transplantation
- Symptomatic interstitial lung disease or lung conditions interfering with toxicity monitoring
- Serious cardiovascular or cerebrovascular disease including severe arrhythmias, recent heart events within 6 months, heart failure NYHA class II or higher, low left ventricular ejection fraction, or uncontrolled hypertension
- Major surgery, investigational treatment or device use, or other anti-cancer therapy within 4 weeks before first drug infusion
- Localized palliative radiotherapy, herbal cancer treatments, minor surgery, or blood-related therapies within 2 weeks before first infusion
- Known intolerance to anti-EGFR monoclonal antibodies causing discontinuation due to severe toxicity
- Positive hepatitis B or C tests above specified viral load thresholds
- Severe allergic reactions to components of the study drug or multiple drugs
- Clinically uncontrollable third interstitial fluid accumulation
- Any other serious or uncontrolled medical condition, active infection needing IV anti-infective therapy, abnormal exams or labs, mental status changes, or psychiatric illness increasing risk or affecting study evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, China, 200123
Actively Recruiting
Research Team
Y
Ye Guo Principal Investigator
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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