Actively Recruiting
RC48-ADC Combined With Radiotherapy in the Treatment of Locally Advanced Solid Tumors With HER2 Expression
Led by RemeGen Co., Ltd. · Updated on 2023-11-27
24
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of Disitamab Vedotin(DV, RC48-ADC) intravenously combined with radiotherapy in the treatment of locally advanced solid tumors with HER2 expression
CONDITIONS
Official Title
RC48-ADC Combined With Radiotherapy in the Treatment of Locally Advanced Solid Tumors With HER2 Expression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary signed informed consent
- Male or female, aged 18 years or older
- Predicted survival of at least 12 weeks
- Locally advanced solid tumors (such as head and neck squamous cell carcinoma, esophageal carcinoma, urothelium carcinoma, cervical carcinoma) that are unresectable, with standard care being concurrent chemoradiation but patient ineligible or refusing standard chemotherapy
- No prior anti-tumor systemic therapy or radiotherapy for the locally advanced solid tumors
- Confirmed HER2 expression by IHC 1+, 2+, or 3+
- At least one measurable lesion according to RECIST 1.1
- ECOG performance status score of 0 or 1
- Adequate heart, bone marrow, liver, and kidney functions within 7 days before study drug administration, including left ventricular ejection fraction ≥ 50%, hemoglobin ≥ 9g/dL, ANC ≥ 1.5 × 10^9/L, platelets ≥ 100 × 10^9/L, serum total bilirubin ≤ 1.5 times ULN, ALT and AST ≤ 2.5 × ULN, blood creatinine ≤ 1.5 × ULN or CrCl ≥ 50 mL/min
- Female subjects must be surgically sterilized, postmenopausal, or agree to use medically approved contraception during treatment and for 6 months after, with a negative pregnancy test within 7 days prior to enrollment and non-lactating
- Male subjects must be surgically sterile or agree to use medically approved contraception during treatment and for 6 months after
- Willing and able to comply with the trial schedule and follow-up procedures
You will not qualify if you...
- Prior anti-tumor therapy before this study, including radiotherapy, targeted therapy, immunotherapy, or participation in other anti-tumor clinical studies
- Major surgery within 4 weeks prior to study without full recovery
- Positive serum virology tests for active Hepatitis B or C infection or HIV
- Received live vaccine within 4 weeks prior to study drug administration or plans to receive vaccines during the study (except Covid-19 vaccine)
- Heart failure of grade 3 or higher (NYHA classification)
- Serious thrombotic events or cardiovascular/cerebrovascular accidents within 1 year prior to study drug, except lacunar cerebral infarction without symptoms or intervention
- Active or progressive infections requiring systemic treatment
- Uncontrolled systemic diseases including diabetes, hypertension, cirrhosis, interstitial pneumonia, obstructive pulmonary disease
- Active autoimmune diseases requiring systemic treatment prior to drug administration
- Other malignant tumors within 5 years prior to study
- Prior treatment with other antibody conjugated drugs
- Known allergy to recombinant humanized anti-HER2 ADC or its components
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shandong Cancer hospital &Institute
Jinan, Shandong, China
Actively Recruiting
Research Team
J
Jianmin Fang, PhD
CONTACT
N
Na Su, PhD
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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