Posterior-line Treatment With Disitamab Vedotin Plus PD-1 in Advanced HER2-low Expressing Gastric Cancer

NCT06078982 | Unknown Phase 1

• 1 other identifier: RCVDGIIIR011
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastric Cancer; HER2-low-expressing Gastric Cancer

Keywords

HER2-low-expressing

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Progression-free survival (PFS)

  12 months after the last subject participating in

• Overall survival (OS)

  12 months after the last subject participating in

• Disease control rate (DCR)

  12 months after the last subject participating in

• Drug-related safety indicators

  12 months after the last subject participating in

Study Arms (1)

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).

Drug: Disitamab Vedotin; Drug: Toripalimab

Interventions

Disitamab Vedotin DRUG

2.0mg/kg, intravenously D1, once every 14 days (Q2W)

Also known as: RC48

Combination of Disitamab Vedotin and Toripalimab

Toripalimab DRUG

3.0 mg/kg, once every 14 days (Q2W)

Combination of Disitamab Vedotin and Toripalimab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Bone marrow function: hemoglobin ≥ 9g/dL; absolute neutrophil count ≥ 1.5×109/L; platelet ≥ 100×109/L;
• Liver function: serum total bilirubin ≤ 1.5 times the upper limit of normal (ULN); when there is no liver metastasis, alanine aminotransferase (ALT), aspartate aminotransferase (AST and alkaline phosphatase (ALP) ≤ 2.5×ULN, and in the presence of liver metastases ALT, AST, and ALP are ≤ 5×ULN;
• Renal function (subject to the normal value of the clinical trial center): blood creatinine ≤ 1.5×ULN, or creatinine clearance rate (CrCl) ≥ 60 mL/min calculated by Cockcroft-Gault formula method, or 24-hour urine CrCl ≥ 60 mL/min;
• Heart function: New York Heart Association (NYHA) classification \< Grade 3; left ventricular ejection fraction ≥ 50%;

You may not qualify if:

• Brain metastasis or leptomeningeal metastasis;
• Tumor lesions with a bleeding tendency (e.g., 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, risk of gastrointestinal hemorrhage in the judgment of the investigator) or previous blood transfusions in the 4 weeks prior to study drug administration;
• Suffering from other malignant tumors within 5 years before signing the informed consent form (non-melanoma skin cancer, cervical carcinoma in situ, ductal carcinoma in situ or other tumors that have been effectively treated, except for malignant tumors that are considered cured);
• Received chemotherapy, radiotherapy, and immune therapy within 4 weeks before the start of the study drug
• Received palliative radiotherapy for bone metastases within 2 weeks before the start of the study drug;
• Received anti-tumor traditional Chinese medicine treatment within 2 weeks before the start of the study drug;
• The toxicity caused by previous anti-tumor therapy has not recovered to CTCAE (version 4.03) grade 0-1 (except for alopecia, hyperpigmentation, and long-term toxicity caused by radiotherapy, which in the judgment of the investigator cannot be recovered);
• Prior treatment with T-DM1 or participation in a clinical study of this type of drug;
• The study drug has been used within 4 weeks before the start of the study drug;
• Major surgery has been performed within 4 weeks before the start of the study drug and the patient has not fully recovered;
• Have been vaccinated with live vaccines within 4 weeks before the start of the study drug or plan to receive any vaccines during the study period;
• Arterial/venous thrombotic events, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis, pulmonary embolism, and myocardial infarction, occurred within 1 year before the study drug;
• Suffering from uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, liver cirrhosis, angina pectoris, serious arrhythmia, etc.;
• Suffering from active infection requiring systemic treatment;
• History of active tuberculosis;

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

disitamab vedotin; toripalimab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Jin Li, MD,PhD

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Li, MD,PhD

CONTACT

+86-13761222111; lijin@csco.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: October 12, 2023
• Study Start: June 6, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: October 12, 2023

Record last verified: 2023-10

Locations

CN (1)