Actively Recruiting
A Study of RC118 in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors
Led by RemeGen Co., Ltd. · Updated on 2025-01-27
135
Participants Needed
2
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In Phase I, This study will explore the tolerability and safety of RC118 in patients with locally advanced unresectable or metastatic malignant solid tumors with positive Claudin 18.2 expression, and determine the maximum tolerated dose (MTD) and the recommended dose in phase II clinical trials (RP2D); In Phase IIa, to explore the clinical effectiveness and safety of long-term use of RC118 at RP2D doses for patients with different tumor types。
CONDITIONS
Official Title
A Study of RC118 in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer to participate and sign informed consent
- Age between 18 and 75 years, any gender
- ECOG performance status of 0 or 1
- Expected survival time longer than 12 weeks
- Disease progression or no remission after standard treatment, or unable to tolerate standard treatment
- Agree to provide tumor tissue samples for Claudin 18.2 testing
- Have at least one measurable or evaluable tumor lesion by CT or MRI
- Adequate bone marrow, liver, and kidney function as defined by specific lab values
- Agree to use effective contraception during the study and for 6 months after last treatment if of reproductive potential
You will not qualify if you...
- Pregnant or breastfeeding women, or positive pregnancy test during screening (unless infertile)
- Positive test for hepatitis B, hepatitis C, or HIV during screening
- History of acquired or congenital immunodeficiency or organ/bone marrow transplant
- Prior targeted therapy for Claudin 18.2 or participation in other drug trials within 4 weeks
- Vaccinated within 4 weeks before first dose or planning vaccination during study
- Allergy to study drug ingredients
- Use of vitamin K antagonists or therapeutic heparin (preventive heparin allowed)
- Anti-tumor therapy within 4 weeks before first dose (palliative radiotherapy for bone metastases within 2 weeks)
- Previous treatment toxicities not resolved to grade 0 or 1 (except hair loss)
- Active pleural, pericardial, or abdominal effusions requiring drainage
- Active infections or other serious diseases affecting safety or study completion
- QTc interval >480 ms or significant cardiac arrhythmias
- Recent serious heart conditions or uncontrolled hypertension
- History of alcohol or drug abuse
- Long-term systemic steroid therapy (short-term use allowed)
- Uncontrolled brain tumors or severe peripheral neuropathy
- Severe mental illness
- Poor compliance or inability to complete study procedures
- Recent serious thrombosis or cardiovascular events
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
2
The first affiliated hospital, zhejiang universtity school of medicine
Hangzhou, Zhejiang, China, 310009
Not Yet Recruiting
Research Team
J
Jianming Fang, 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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