Disitamab Vedotin Plus Trastuzumab in Patients With HER2 Positive GC/GEJ Patiens

Phase 1

Recruiting

• Conditions: HER2-positive Gastric Cancer; HER2-positive Gastroesophageal Junction Adenocarcinoma

• Registration Number: NCT06572319
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-23
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Sign the informed consent form; 2.18-75 years old (including 18 years old, excluding<br> 75 years old), gender not limited; 3. The pathological histology confirmed by<br> pathology is adenocarcinoma of the gastric/gastroesophageal junction; 4. HER2<br> positive tumor criteria (primary tumor or metastatic lesion, HER2 positive is<br> defined as IHC 2+/FISH+(HER2: CEP17 ratio = 2.0) or IHC (3+). Using the criteria for<br> interpreting HER2 in gastric cancer 5. Recurrent or metastatic diseases that cannot<br> be surgically treated, with at least one measurable lesion (RECIST 1.1 criteria) in<br> the subject and an estimated survival time of at least 12 weeks; 6. ECOG score<br> ranges from 0 to 1 points; 7. At least first-line systemic therapy has failed<br> (regardless of whether it includes anti-HER2 monoclonal antibody therapy); 8. Having<br> sufficient bone marrow, liver and kidney function:<br><br> - Absolute neutrophil count (ANC) = 1.5 × 109/L, platelets = 90 × 109/L, or<br><br> - hemoglobin = 9g/dL;<br><br> - ALT or AST levels without liver metastasis are less than 2.5 times the upper limit<br> of the normal range; When liver metastasis occurs, ALT or AST is less than 5 times<br> the upper limit of the normal range; Serum bilirubin is 1.5 times lower than the<br> upper limit of the normal reference range;<br><br> - Serum creatinine is lower than 1.5 times the upper limit of the normal reference<br> range or creatinine clearance rate is = 40ml/min; 9. Women of childbearing age and<br> their spouses are willing to use effective contraceptive methods within the last 7<br> months of treatment.<br><br>Exclusion Criteria:<br><br> 1. Known to be allergic to the received therapeutic drugs or excipients;<br><br> 2. Baseline LVEF<50% (measured by echocardiography or MUGA);<br><br> 3. Previously received treatment with anti-HER2 ADC drugs;<br><br> 4. Individuals who have undergone systemic immunotherapy, biologic therapy, or<br> participated in any clinical drug trials within the past 2 weeks;<br><br> 5. Those who have undergone surgery within 3 weeks before the start of the experimental<br> treatment and have not fully recovered;<br><br> 6. Patients with uncontrolled central nervous system (CNS) metastases or epilepsy<br> requiring medication treatment;<br><br> 7. Serious systemic diseases. Such as infected or uncontrolled diabetes;<br><br> 8. Suffering from other malignant tumors within 5 years, except for non melanoma skin<br> cancer and cervical carcinoma in situ;<br><br> 9. Clinically symptomatic active coronary heart disease, cardiomyopathy, or congestive<br> heart failure, NYHA III-IV; uncontrolled hypertension (systolic blood pressure>180<br> mmHg or diastolic blood pressure>100 mmHg), clinically symptomatic heart valve<br> disease, or high-risk arrhythmia;<br><br> 10. Patients receiving long-term or high-dose corticosteroid treatment (inhaled steroids<br> or short-term oral steroids are allowed to resist vomiting or promote appetite)<br><br> 11. Individuals without legal capacity, those whose medical or ethical reasons affect<br> the continuation of research;<br><br> 12. Pregnant and lactating female patients, or those who wish to become pregnant during<br> treatment;<br><br> 13. Uncontrolled pleural and peritoneal effusion;<br><br> 14. There is a persistent infection of>level 2 (CTC-AE 4.0); Wounds, ulcers, or<br> fractures that cannot heal, or patients with a history of organ transplantation;<br><br> 15. There are unresolved toxicity levels>1 caused by any previous treatment/procedure<br> (CTC-AE 4.0, excluding hair loss, anemia, and hypothyroidism);<br><br> 16. After comprehensive assessment of the patient's condition by the researchers, it is<br> deemed that they are not suitable to participate in this study;<br><br> 17. Simultaneously participating in another clinical study.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective response rate(ORR)

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS);Progression-free survival (PFS);Disease control rate (DCR);Incidence of Treatment-Emergent 3/4 Adverse Events