Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single-arm, prospective, non-randomized, multi-center/single-center, open-label, phase I clinical study aimed at evaluating the efficacy and safety of Disitamab Vedotin in combination with PD-1 as posterior line treatment for patients with advanced HER2-low expressing gastric cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination of Disitamab Vedotin and Toripalimab | Experimental | Participants will receive Disitamab Vedotin + Toripalimab every 2 weeks (Q2W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Disitamab Vedotin | Drug | 2.0mg/kg, intravenously D1, once every 14 days (Q2W) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR) per RECIST version 1.1 | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Progression-free survival (PFS per RECIST 1.1) is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first | 12 months after the last subject participating in |
| Overall survival (OS) |
Not provided
Inclusion Criteria:
Must voluntarily join this study and sign an informed consent form;
Age 18-70 years old (including 18 years old and 70 years old);
Expected survival period ≥ 12 weeks;
ECOG physical fitness score 0 or 1 point;
Patients with incurable and unresectable locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) confirmed by histology or cytology;
The HER2 immunohistochemistry (IHC) test results are IHC 1+, the subject's previous test results (confirmed by the investigator) or the test results of the research center are acceptable;
The patient has received second-line treatment (at least) after tumor recurrence/metastasis
Evidence of tumor disease progression during or after the most recent treatment, as documented by medical history or confirmed by the investigator;
At least one measurable lesion according to RECIST 1.1;
For female subjects: should be surgically sterilized, postmenopausal patients, or agree to use at least one medically approved contraceptive measure (such as an intrauterine device, contraceptives) during the study treatment period and within 6 months after the end of the study treatment period. pills or condoms), must have a negative blood pregnancy test within 7 days prior to study enrollment, and must be non-lactating; for male subjects: should for surgical sterilization, or agree to use a medically approved contraceptive method during the study treatment period and within 6 months after the end of the study treatment period of the experimental group subjects;
Sufficient organ function:
Able to understand trial requirements, willing and able to comply with trial and follow-up procedures.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Li, MD,PhD | Contact | +86-13761222111 | lijin@csco.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jin Li, MD,PhD | Shanghai East Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Recruiting | Shanghai | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000722994 | disitamab vedotin |
| C000656314 | toripalimab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Toripalimab | Drug | 3.0 mg/kg, once every 14 days (Q2W) |
|
OS is defined as the time from the starting date of study drug to the date of death due to any cause. |
| 12 months after the last subject participating in |
| Disease control rate (DCR) | The proportion of subjects with complete response (CR) and partial response (PR) and stable disease (SD)in total subjects | 12 months after the last subject participating in |
| Drug-related safety indicators | Exposure to the investigational drug and incidence, nature, and severity of adverse events, including serious adverse events(n, %) | 12 months after the last subject participating in |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |