BridgeMD
New treatment option for Gastric Cancer
Official title DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy
ClinicalTrials.gov ID: NCT06221748
What this study is testing
What is Disitamab Vedotin Injection?
Disitamab Vedotin Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric cancer.
Also referred to as DV,RC48.
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
- The purpose of this study is to evaluate the efficacy and safety of Disitamab Vedotin Combined with Cadonilimab in subjects with HER2-expressing locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma after progression on first-line therapy.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Voluntarily agreed to participate in the study and signed an informed consent form;
- Age 18-75 years(both 18 and 75);
- Expected survival ≥ 12 weeks
- ECOG physical condition score of 0 or 1
- Locally advanced or metastatic gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) confirmed by histology and/or...
You likely can't join if
- Metastatic CNS and/or meningeal carcinomatosis；
- prior treatment with any antibody-drug conjugate including Disitamab Vedotin For Injection; prior treatment with cardinolizumab
- Prior anti-cancer therapy resulting in toxicity that has not recovered to CTCAE (version 5.0) ≤ Grade 1 (except for hair loss, hyperpigmentation, or...
- Radical radiotherapy within 3 months prior to study dosing; palliative radiotherapy 2 weeks prior to dosing is permitted, at a dose that meets local...
- Prior major surgery within 4 weeks before study dose start and incomplete recovery
- Received a live vaccine within 28 days prior to the start of the first study dose or plan to receive any vaccine during the study period
See the full eligibility criteria
Who can join
- Voluntarily agreed to participate in the study and signed an informed consent form;
- Age 18-75 years(both 18 and 75);
- Expected survival ≥ 12 weeks
- ECOG physical condition score of 0 or 1
- Locally advanced or metastatic gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) confirmed by histology and/or cytology
- people will only have failed or been intolerant to prior standard first-line therapy (excluding paclitaxel), with no restriction on prior treatment with a PD-1/PD-L1 inhibitor.
- Confirmation of HER2 (IHC 1+, 2+, or 3+) and PD-L1 expression: for Phase II enrolled people, results of investigator-confirmed HER2 and PD-L1 expression will be accepted; for Phase III enrolled people, HER2 and PD-L1...
- Bone marrow function:
- Hemoglobin ≥ 9 g/dL (no blood transfusion and no erythropoietin treatment within 2 weeks prior to the examination);
- Absolute neutrophil count ≥ 1.5 × 109/L (must not receive granulocyte colony-stimulating factor treatment within 2 weeks prior to the examination)
- Platelet count ≥ 90 × 109/L (no platelet transfusion or treatment with recombinant human thrombopoietin within 2 weeks before the test);
- Liver function (based on normal values at the Clinical Trials Center):
- Serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN);
- Alanine aminotransferase (ALT) and Mentholatum aminotransferase (AST) ≤ 2.5 × ULN in the absence of hepatic metastases; ALT and AST ≤ 5 × ULN in the presence of hepatic metastases;
- Renal function (based on normal values at the Clinical Trials Center): Blood creatinine ≤ 1.5 x ULN, or creatinine clearance (CrCl) ≥ 60 mL/min calculated by the Cockcroft-Gault formula method, or measured 24-hour urine...
- Coagulation:
- Prothrombin time (PT) ≤ 1.5 x ULN;
- Thrombin time (TT) ≤ 1.5 × ULN;
- Activated partial thromboplastin time (APTT) ≤ 1.5×ULN;
- Cardiac function:
- New York Heart Association (NYHA) classification \<3;
- Left ventricular ejection fraction (LVEF) ≥ 50%;
- The subject is able to provide specimens for central laboratory testing/review (at least 5 tissue sections) from the site of the primary or metastatic focus of the tumor within 3 years, preferably specimens taken after...
- Have at least one measurable lesion according to RECISTv1.1 criteria;
- For female people: should be surgically sterilized, post-menopausal, or agree to use a medically approved contraceptive method (e.g., IUD, birth control pills, or condoms) for the duration of the study treatment and for...
- Be able to understand the requirements of the trial and be willing and able to comply with the trial and follow-up procedures.
What rules you out
- Metastatic CNS and/or meningeal carcinomatosis；
- prior treatment with any antibody-drug conjugate including Disitamab Vedotin For Injection; prior treatment with cardinolizumab
- Prior anti-cancer therapy resulting in toxicity that has not recovered to CTCAE (version 5.0) ≤ Grade 1 (except for hair loss, hyperpigmentation, or other conditions that do not increase the risk of the subject's use of...
- Radical radiotherapy within 3 months prior to study dosing; palliative radiotherapy 2 weeks prior to dosing is permitted, at a dose that meets local diagnostic criteria for palliative care and with radiotherapy coverage...
- Prior major surgery within 4 weeks before study dose start and incomplete recovery
- Received a live vaccine within 28 days prior to the start of the first study dose or plan to receive any vaccine during the study period
- Third interstitial effusion associated with clinical symptoms or that requires symptomatic treatment;
- Ongoing grade ≥2 sensorimotor or motoneuropathy;
- serum virology (based on site normal values):
- Positive Hepatitis B virus surface antigen (HBsAg) test result with a positive HBV DNA copy number;
- Positive test result for Hepatitis C Antibody (HCVAb) (enrollment in the study is only possible if the PCR test result for HCV RNA is negative);
- Positive test result for human immunodeficiency virus antibody (HIVAb).；
- Serious arterial/venous or cardiovascular accidents, such as deep vein thrombosis ( except asymptomatic interstitial vein thrombosis which does not require special treatment), pulmonary embolism, cerebral infarction...
- Tumor lesions with bleeding tendency (e.g., presence of active ulcerated tumor lesions with a positive fecal occult blood test, history of vomiting blood or black stools within 2 months prior to signing the informed...
- The occurrence of an active or progressive infection requiring systemic treatment (trial drug may be initiated 2 weeks after completion of anti-infective therapy);
- The presence of unsteady controlled systemic disease as judged by the investigator, including diabetes and hypertension, hepatocirrhosis, interstitial pneumonitis, and obstructive lung disease.
- The existence of active autoimmune disease requiring systemic therapy (e.g., use of immunomodulatory agents, corticosteroids, or immunosuppressive agents) within 2 years prior to the start of study dosing, allowing for...
- Other malignancy within 5 years prior to the start of study dosing, with the exception of the following: malignancies that are expected to resolve with treatment (including, but not limited to, adequately treated...
- prior history of allogeneic hematopoietic stem cell transplantation or organ transplantation;
- known hypersensitivity to immunosuppressants and any other antibody-drug conjugate and their components and any of the drugs in this study;
- women who are pregnant or breast-feeding;
- Any other disease, metabolic abnormality, physical examination abnormality, or laboratory test abnormality that, in the judgment of the Investigator, gives reason to suspect that the subject has a disease or condition...
- people whose participation in this study is estimated to be insufficiently adherent or who, in the judgment of the investigator, have other factors that make them unsuitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Xiamen, Fujian, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Xuzhou, Jiangsu, China
- Jinan, Shandong, China
- Qingdao, Shandong, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Kunming, Yunnan, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Xiamen, Fujian, China; Harbin, Heilongjiang, China; Zhengzhou, Henan, China; Wuhan, Hubei, China; Changsha, Hunan, China and 6 more location(s). 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.