Actively Recruiting
Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of CMAB017 in Advanced Malignant Solid Tumors A Multicenter, Open-label Phase I Clinical Study
Led by Taizhou Mabtech Pharmaceutical Co.,Ltd · Updated on 2025-09-11
55
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor effects of CMAB017 in patients with advanced malignant solid tumors. This multicenter, open-label phase Ia study aims to better understand how this drug behaves in the body and its potential impact on various solid tumors where standard treatments have failed, are unavailable, or refused. Participants receive CMAB017 administered intravenously either every two weeks or every three weeks during the core study period, which includes the first four doses. After completing this period and dose escalation, those showing therapeutic effects and tolerable side effects may continue treatment in an extension period. This extension phase allows further assessment of long-term safety, drug behavior in the body, immune response, and anti-tumor activity. Throughout the study, participants will undergo regular evaluations, including blood tests to monitor drug levels and immune responses, as well as safety checks for adverse effects. Researchers will measure dose limiting toxicities and maximal tolerated dose up to 12 weeks, along with secondary measures such as blood concentration levels and antibody formation over up to one year. The total study period includes core and extension phases to observe both short- and long-term outcomes.
CONDITIONS
Brief 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.
- Age between 18 and 75 years, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Expected survival of at least 3 months
- At least one evaluable lesion according to RECIST version 1.1, excluding bone-only or central nervous system-only metastases
- Females of childbearing potential must be non-lactating with a negative pregnancy test within 1 week prior to first infusion and agree to use effective contraception until 6 months after last infusion; males must agree to use contraception for the same period
- Blood tests meeting specified thresholds for neutrophils, platelets, hemoglobin, liver function, coagulation, and renal function during screening
You will not qualify if you...
- Active central nervous system metastases or carcinomatous meningitis, unless clinically stable for at least 2 weeks and off steroids
- Grade 2 or higher corneal abnormalities at screening
- Unresolved adverse effects from prior cancer therapy above specified severity
- Other malignancies within the past 5 years except certain treated or low-risk cancers
- History of immunodeficiency, organ transplantation, or positive HIV test
- Symptomatic interstitial lung disease or conditions affecting lung monitoring
- Serious cardiovascular or cerebrovascular disease including significant arrhythmias, heart failure, recent acute events, or uncontrolled hypertension
- Major surgery, investigational treatments, or other cancer therapies within 4 weeks prior to first dose
- Localized palliative radiotherapy, minor surgery, herbal oncology treatments, or blood product therapies within 2 weeks prior to first dose
- Known intolerance to anti-EGFR monoclonal antibodies causing severe side effects
- Positive hepatitis B or C viral markers above specified thresholds
- Severe allergic reactions to study drug components
- Uncontrolled third space fluid accumulation
- Other serious medical or psychiatric conditions increasing risk or affecting study evaluation
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 12 weeks
Participants receive CMAB017 drug infusions by intravenous infusion every 2 or 3 weeks in the core period, with dose adjustments based on body weight changes. This period evaluates safety, tolerability, and pharmacokinetics after four administrations.
4 drug administration visits every 2 or 3 weeks
Duration - Variable duration depending on therapeutic effect and tolerability
Participants who respond well and tolerate the drug continue receiving CMAB017 to observe long-term safety, pharmacokinetics, immunogenicity, and anti-tumor effects.
Visits scheduled according to continued drug administration in the extension period
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, China, 200123
Actively Recruiting
Research Team
Y
Ye Guo Principal Investigator
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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