Actively Recruiting
JMT106 Injection in the Treatment of Advanced Solid Tumors
Led by Shanghai JMT-Bio Inc. · Updated on 2025-12-18
200
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is the first-in-human Phase I study of JMT106 injection, comprising two phases: Dose escalation with backfill and cohort expansion. The planned study population consists of subjects with advanced solid tumors. The objective is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of JMT106 injection as monotherapy in participants with advanced solid tumors
CONDITIONS
Official Title
JMT106 Injection in the Treatment of Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed advanced solid tumor
- Failure of at least one line of standard therapy, or no standard treatment available, or intolerant to standard treatment
- At least one measurable tumor lesion according to RECIST 1.1
- ECOG performance status of 0 or 1
- Expected survival of 3 months or more
- Adequate organ function as shown by laboratory tests without recent blood transfusion or growth factor treatment
- Agreement by fertile participants to use reliable contraception during the trial and for 180 days after last dose
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before enrollment
- Ability to understand and voluntarily sign the informed consent form
You will not qualify if you...
- Previous treatment with anti-GPC3 therapy
- Spinal cord compression or active brain metastases requiring treatment or symptomatic
- Long-term immunosuppressive or daily systemic steroid therapy exceeding specified doses
- Unresolved severe adverse reactions from prior antitumor therapy
- Recent antitumor therapy or investigational interventions within defined timeframes
- Grade 3 or higher immune-related adverse events from prior immunotherapy
- Participation in another interventional clinical trial
- Major surgery within 28 days before first dose or planned tumor surgery during study
- Significant bleeding risks or hereditary bleeding disorders
- Known severe allergy to study drug or excipients
- Active infections requiring intravenous treatment within 14 days before randomization
- Uncontrolled fluid accumulations requiring frequent drainage
- History of organ or stem cell transplantation
- Immunodeficiency including HIV positive status
- Active hepatitis B or C infection with viral load above thresholds
- History of tuberculosis treatment within 2 years
- Interstitial lung disease or severe lung dysfunction
- History of inflammatory bowel disease or chronic diarrhea
- Severe cardiovascular or cerebrovascular disease including recent major events or uncontrolled hypertension
- Other active cancers within 2 years except certain cured localized tumors
- Live vaccination within 28 days before first dose
- Pregnancy or lactation
- Other conditions deemed unsuitable by investigator including psychiatric disorders or tumor thrombus
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affilicated Hospital,Zhejiang University School of Medicine
Zhejiang, China
Actively Recruiting
Research Team
L
Liang Ting bo, Ph.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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