Actively Recruiting
DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy
Led by RemeGen Co., Ltd. · Updated on 2024-04-03
90
Participants Needed
12
Research Sites
196 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DV Combined With Cadonilimab in Subjects With HER2-expressing Gastric Cancer and Gastroesophageal Junction Adenocarcinoma After Progression on First-line Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agreed to participate and signed informed consent
- Age between 18 and 75 years inclusive
- Expected survival of at least 12 weeks
- ECOG physical condition score of 0 or 1
- Confirmed locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma by histology or cytology
- Failed or intolerant to prior standard first-line therapy (excluding paclitaxel); prior PD-1/PD-L1 inhibitor allowed
- Confirmation of HER2 expression (IHC 1+, 2+, or 3+) and PD-L1 expression
- Adequate bone marrow function with specified hemoglobin, neutrophil, and platelet counts
- Liver function within defined limits based on bilirubin and liver enzymes
- Renal function with creatinine or creatinine clearance within specified limits
- Coagulation parameters within specified limits
- Cardiac function with NYHA classification less than 3 and left ventricular ejection fraction 50% or more
- Ability to provide tumor tissue specimens for testing within 3 years
- At least one measurable lesion per RECISTv1.1 criteria
- For females: surgically sterilized, post-menopausal, or agree to use contraception during and 6 months after treatment; negative pregnancy test; not breastfeeding; no egg donation for 6 months
- For males: surgically sterilized or agree to contraception during and 6 months after treatment; no sperm donation until 4 months after last dose
- Ability to understand and comply with trial and follow-up procedures
You will not qualify if you...
- Metastatic central nervous system or meningeal carcinomatosis
- Prior treatment with antibody-drug conjugates including Disitamab Vedotin or Cadonilimab
- Unresolved toxicity from prior anti-cancer therapy greater than CTCAE Grade 1 (except certain conditions)
- Recent radical radiotherapy within 3 months; palliative radiotherapy less than 2 weeks prior permitted under conditions
- Major surgery within 4 weeks before study without full recovery
- Live vaccine within 28 days before first dose or planned vaccination during study
- Symptomatic third interstitial effusion requiring treatment
- Ongoing grade 2 or higher sensorimotor or motoneuropathy
- Positive tests for active Hepatitis B, Hepatitis C (unless RNA negative), or HIV
- Serious cardiovascular events within 6 months prior to study drug
- Tumor lesions with bleeding risk or recent blood transfusion
- Active or progressive infection needing treatment
- Uncontrolled systemic diseases including diabetes, hypertension, liver cirrhosis, lung diseases
- Active autoimmune disease requiring systemic therapy within 2 years
- Other malignancies within 5 years except certain treated cancers
- History of allogeneic hematopoietic stem cell or organ transplantation
- Known hypersensitivity to study drugs or similar agents
- Pregnant or breastfeeding women
- Any other medical condition or abnormality making study participation unsafe or unsuitable
- Estimated insufficient adherence or other investigator-determined unsuitability for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361003
Not Yet Recruiting
3
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
4
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
5
Hubei Cancer Hospital
Wuhan, Hubei, China, 430079
Not Yet Recruiting
6
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Actively Recruiting
7
Xuzhou Central Hospital
Xuzhou, Jiangsu, China, 221009
Actively Recruiting
8
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
9
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266003
Not Yet Recruiting
10
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Not Yet Recruiting
11
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
12
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650118
Actively Recruiting
Research Team
J
Jianmin Fang, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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