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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2 / Phase 3INTERVENTIONAL

DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy

A Randomized,Multicenter, Open-Label,Phase II/III Study to Evaluate the Safety and Efficacy of Disitamab Vedotin Combined With Cadonilimab in Subjects With HER2-expressing Locally Advanced or Metastatic Gastric Cancer and Gastroesophageal Junction Adenocarcinoma Who Have Progressed on r First-line Therapy

DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy (NCT06221748) is a Phase 2 / Phase 3 interventional studying Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, sponsored by RemeGen Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Gastric Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 90 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Gastric Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Voluntarily agreed to participate in the study and signed an willing to sign a consent form form; 2. Age 18-75 years(both 18 and 75); 3. Expected survival ≥ 12 weeks 4. ECOG physical condition score of 0 or 1 5. Locally advanced or metastatic gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) confirmed by histology and/or cytology 6. Subjects 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. 7. Confirmation of HER2 (IHC 1+, 2+, or 3+) and PD-L1 expression: for Phase II enrolled subjects, results of investigator-confirmed HER2 and PD-L1 expression will be accepted; for Phase III enrolled subjects, HER2 and PD-L1 expression will be accepted only as results from the central laboratory. 8. Bone marrow function: 1. blood count (hemoglobin) at least 9 g/dL (no blood transfusion and no erythropoietin treatment within 2 weeks prior to the examination); 2. Absolute neutrophil count ≥ 1.5 × 109/L (must not receive granulocyte colony-stimulating factor treatment within 2 weeks prior to the examination) 3. Platelet count ≥ 90 × 109/L (no platelet transfusion or treatment with recombinant human thrombopoietin within 2 weeks before the test); 9. Liver function (based on normal values at the Clinical Trials Center): 1. Serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN); 2. 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; 10. 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 CrCl ≥ 60 mL/min; 11. Coagulation: 1. Prothrombin time (PT) ≤ 1.5 x ULN; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Voluntarily agreed to participate in the study and signed an informed consent form; 2. Age 18-75 years(both 18 and 75); 3. Expected survival ≥ 12 weeks 4. ECOG physical condition score of 0 or 1 5. Locally advanced or metastatic gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) confirmed by histology and/or cytology 6. Subjects 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. 7. Confirmation of HER2 (IHC 1+, 2+, or 3+) and PD-L1 expression: for Phase II enrolled subjects, results of investigator-confirmed HER2 and PD-L1 expression will be accepted; for Phase III enrolled subjects, HER2 and PD-L1 expression will be accepted only as results from the central laboratory. 8. Bone marrow function: 1. Hemoglobin ≥ 9 g/dL (no blood transfusion and no erythropoietin treatment within 2 weeks prior to the examination); 2. Absolute neutrophil count ≥ 1.5 × 109/L (must not receive granulocyte colony-stimulating factor treatment within 2 weeks prior to the examination) 3. Platelet count ≥ 90 × 109/L (no platelet transfusion or treatment with recombinant human thrombopoietin within 2 weeks before the test); 9. Liver function (based on normal values at the Clinical Trials Center): 1. Serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN); 2. 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; 10. 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 CrCl ≥ 60 mL/min; 11. Coagulation: 1. Prothrombin time (PT) ≤ 1.5 x ULN; 2. Thrombin time (TT) ≤ 1.5 × ULN; 3. Activated partial thromboplastin time (APTT) ≤ 1.5×ULN; 12. Cardiac function: * New York Heart Association (NYHA) classification \<3; * Left ventricular ejection fraction (LVEF) ≥ 50%; 13. 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 failure of first-line therapy; 14. Have at least one measurable lesion according to RECISTv1.1 criteria; 15. For female subjects: 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 6 months after the end of the study treatment period; must have had a negative blood pregnancy test within 7 days prior to the study drug administration and must not be breastfeeding; and must not donate eggs for a period of 6 months from the time of signing of the informed consent form to the time of the last administration of the study drug. No egg donation for 6 months. For male subjects: should be surgically sterilized or agree to use a medically approved method of contraception during and for 6 months after the end of study treatment; no sperm donation from the time of signing the informed consent until at least 4 months after the last dose of study drug; 16. Be able to understand the requirements of the trial and be willing and able to comply with the trial and follow-up procedures. Exclusion Criteria: 1. Metastatic CNS and/or meningeal carcinomatosis; 2. prior treatment with any antibody-drug conjugate including Disitamab Vedotin For Injection; prior treatment with cardinolizumab 3. 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 the drug determined by the investigators; 4. 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 of less than 30% of the bone marrow area; 5. Prior major surgery within 4 weeks before study dose start and incomplete recovery 6. 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 7. Third interstitial effusion associated with clinical symptoms or that requires symptomatic treatment; 8. Ongoing grade ≥2 sensorimotor or motoneuropathy; 9. serum virology (based on site normal values): 1. Positive Hepatitis B virus surface antigen (HBsAg) test result with a positive HBV DNA copy number; 2. 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); 3. Positive test result for human immunodeficiency virus antibody (HIVAb).; 10. 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, cerebral hemorrhage, myocardial infarction, angina pectoris, etc., except for lacunar cerebral infarction, which is asymptomatic and does not require clinical intervention, have occurred in the last 6 months prior to the study drug administration; 11. 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 consent form, risk of gastrointestinal hemorrhage in the judgment of the investigator, etc.), or receipt of blood transfusion 4 weeks prior to study drug administration;; 12. The occurrence of an active or progressive infection requiring systemic treatment (trial drug may be initiated 2 weeks after completion of anti-infective therapy); 13. The presence of unsteady controlled systemic disease as judged by the investigator, including diabetes and hypertension, hepatocirrhosis, interstitial pneumonitis, and obstructive lung disease. 14. 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 related replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for renal or pituitary insufficiency); 15. 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 thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated by radical surgery); 16. prior history of allogeneic hematopoietic stem cell transplantation or organ transplantation; 17. known hypersensitivity to immunosuppressants and any other antibody-drug conjugate and their components and any of the drugs in this study; 18. women who are pregnant or breast-feeding; 19. 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 that is unsuitable for the use of the study medication, would interfere with the interpretation of the results of the study, or puts the subject at a high risk of developing a condition; 20. subjects 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.

Treatments Being Tested

DRUG

Disitamab Vedotin Injection

Phase II and III study :2.5mg/kg, intravenous infusion,D1, every 2 weeks

DRUG

Cadonilimab Injection

Phase II and III study :6.0mg/kg, intravenous infusion,D1, every 2 weeks.

DRUG

Paclitaxel Injection

Phase II and III study :Calculate dosage based on body surface are,160mg/m2,intravenous infusion,D1,D8 every 3 weeks

Locations (12)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Shandong Cancer Hospital
Jinan, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Yunnan Cancer Hospital
Kunming, Yunnan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06221748), the sponsor (RemeGen Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06221748 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06221748?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06221748?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06221748. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06221748. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.