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New treatment option for Solid Tumor
Official title RC48-ADC Combined With Radiotherapy in the Treatment of Locally Advanced Solid Tumors With HER2 Expression
ClinicalTrials.gov ID: NCT05940896
What this study is testing
What is Disitamab vedotin?
Disitamab vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor.
Also referred to as RC48-ADC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Voluntary signed informed consent,
- Male or female, aged ≥18 years,
- Predicted survival ≥ 12 weeks;
- Based on the investigator's evaluation (histopathological classification and clinical staging), patients with locally advanced solid tumors (head and...
- The subject has not been given any anti-tumor systemic therapy or radiotherapy for locally advanced solid tumors in the past
You likely can't join if
- Received anti-tumor therapy before this study, including radiotherapy, target therapy, immunotherapy, and any anti-tumor clinical studies;
- The subject was given a major surgery and did not fully recover within 4 weeks prior to the study;
- Serum virology examination (based on the normal value of the site): HBsAg or HBcAb test results are positive, while HBV DNA copy is detected as...
- The subject was given live vaccine within 4 weeks before the study drug is given or planed to receive any vaccine during the study period (except for...
- Heart failure≥ 3 grade（NYHA）
- Serious arteriovenous thrombotic events or cardiovascular and cerebrovascular accidents, such as deep vein thrombosis, pulmonary embolism, cerebral...
See the full eligibility criteria
- Voluntary signed informed consent,
- Male or female, aged ≥18 years,
- Predicted survival ≥ 12 weeks;
- Based on the investigator's evaluation (histopathological classification and clinical staging), patients with locally advanced solid tumors (head and neck squamous cell carcinoma, esophageal carcinoma, urothelium...
- The subject has not been given any anti-tumor systemic therapy or radiotherapy for locally advanced solid tumors in the past
- HER2 expression is confirmed by the site: 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, which should meet the following standards within 7 days before the study drug is given (based on the normal values of the site) : Left ventricular ejection...
- Female people: should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive (such as an intrauterine device, contraceptives, or condoms) during study treatment and within 6 months...
- Willing and able to comply with the schedules of the trial and follow-up procedures.
- Received anti-tumor therapy before this study, including radiotherapy, target therapy, immunotherapy, and any anti-tumor clinical studies;
- The subject was given a major surgery and did not fully recover within 4 weeks prior to the study;
- Serum virology examination (based on the normal value of the site): HBsAg or HBcAb test results are positive, while HBV DNA copy is detected as positive; The HCVAb test result is positive (only when the PCR test result...
- The subject was given live vaccine within 4 weeks before the study drug is given or planed to receive any vaccine during the study period (except for Covid-19 vaccine);
- Heart failure≥ 3 grade（NYHA）
- Serious arteriovenous thrombotic events or cardiovascular and cerebrovascular accidents, such as deep vein thrombosis, pulmonary embolism, cerebral infarction, cerebral hemorrhage, myocardial infarction, etc., occurred...
- There are active or progressive infections that require systematic treatment, such as active pulmonary tuberculosis;
- There are systemic diseases that have not been controlled stably as judged by the investigator, including diabetes, hypertension, cirrhosis, interstitial pneumonia, obstructive pulmonary disease, etc;
- Active autoimmune diseases that require systematic treatment (such as the use of immunomodulators, corticosteroids, or immunosuppressants) prior to the start of drug administration, allowing for related alternative...
- Patients with other malignant tumors within 5 years prior to the start of study administration;
- Previously received other antibody conjugated drug treatments;
- Those who are known to be allergic to recombinant humanized anti HER2-ADC and components;
- Pregnant or lactating women;
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.