Actively Recruiting
RC118 Injection for Locally Advanced Unresectable or Metastatic Malignant Solid Tumors Targeting Claudin 18.2: An Open Phase I/IIa Multi-center Study
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
Researchers are evaluating the safety, tolerability, and effectiveness of RC118 in patients with locally advanced unresectable or metastatic malignant solid tumors that express Claudin 18.2. This open, single-arm, multi-center Phase I/IIa study aims to find the maximum tolerated dose (MTD) and recommended dose for Phase II trials in the Phase I portion. The Phase IIa part explores the long-term clinical effectiveness and safety of RC118 at the recommended dose across different tumor types, including gastric, esophageal, gastroesophageal junction, pancreatic, ovarian cancers, and cholangiocarcinoma. The study involves a dose-escalation phase with seven preset dose groups ranging from 0.25 mg/kg to 3.0 mg/kg of RC118, a novel antibody-drug conjugate targeting Claudin 18.2. After determining the MTD and maximum administered dose in Phase I, dose confirmation is done with 1 to 2 groups of 3 to 6 subjects each. Phase IIa expands to include about 30 subjects per tumor group treated at the recommended dose, focusing mainly on gastric and pancreatic cancers. Treatment is given by injection, and tumor tissue testing for Claudin 18.2 expression is required for eligibility. Participants will undergo assessments including imaging scans (CT/MRI) to measure tumor response, laboratory tests to monitor blood counts and organ function, and evaluations for adverse events. Safety monitoring occurs from consent through 28 days after the last treatment, with dose-limiting toxicity assessed within 28 days of first treatment. The main outcomes measured are safety, tolerability, and objective response rate over 15 months. Participants must have measurable tumors and adequate health status to join and will be followed closely throughout the study.
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
Complete this quick 3-step screening to check your eligibility
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here