RC48 Plus AK104 as First-line Treatment for HER2-overexpressing Advanced Gastric Cancer

NCT06492317 | Not Yet Recruiting Phase 2

• 1 other identifier: S2021-K006-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A single-arm, single-center phase II trial study to assess the efficacy and safety of disitamab vedotin plus cadonilimab as first-line therapy for HER2-overexpressing advanced stomach carcinoma

Conditions

HER2-positive Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR)

  The proportion of subjects with complete response (CR) and partial response (PR) in total subjects

  6 months after the last subject participating in

Secondary Outcomes (5)

• duration of response (DOR)

  12 months after the last subject participating in

• disease control rate (DCR)

  12 months after the last subject participating in

• time to response (TTR)

  12 months after the last subject participating in

• progression-free survival (PFS)

  12 months after the last subject participating in

• overall survival (OS)

  12 months after the last subject participating in

Study Arms (1)

Disitamab vedotin plus cadonilimab

EXPERIMENTAL

Disitamab vedotin: 2.5mg/kg, D1, ivdrip, Q2W (every 2 weeks) ; Cadonilimab: 6mg/kg, D1, ivdrip, Q2W (every 2 weeks) ; until progressive disease (PD) or intolerable toxicity

Drug: Disitamab Vedotin; Drug: Cadonilimab

Interventions

Disitamab Vedotin DRUG

Disitamab Vedotin: 2.5mg/kg, d1, ivdrip, Q2W (every 2 weeks)

Also known as: RC48

Disitamab vedotin plus cadonilimab

Cadonilimab DRUG

Cadonilimab: 6mg/kg, d1, ivdrip, Q2W (every 2 weeks)

Also known as: AK104

Disitamab vedotin plus cadonilimab

Eligibility Criteria

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

You may qualify if:

• Age: more than 18 years, gender is not limited;
• Confirmed locally advanced or distant metastasis gastric or gastroesophageal junction adenocarcinoma that is inoperable by pathological examination;
• Confirmed HER2 2+or 3+ by immunohistochemistry (IHC);
• At least 1 measurable lesion as determined by RECIST 1.1;
• There is no prior systematic treatment, or the patient has received neoadjuvant/adjuvant chemotherapy, and the disease progresses or relapses more than 6 months after the treatment;
• Eastern Cooperative Oncology Group (ECOG)performance status of 0-1;
• Adequate organ function:
• Bone marrow function: Hemoglobin count (HGB)≥80g/L;
• Neutrophil count (NE)≥1.5×109/L;
• White blood cell count (WBC)≥3.5×109/L;
• Platelet count (PLT)≥100×109/L；
• Liver function: i. Serum total bilirubin (TBIL)≤1.5×ULN; ii. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP)≤3×ULN, patients with liver metastasis≤5×ULN;
• Kidney function: Blood creatinine (Cr) ≤1.5×ULN or Cockcroft Gault formula ≥ 60 mL/min;
• Cardiac function: New York Heart Association (NYHA) classification\<Grade 3; Left ventricular ejection fraction≥50%;
• At least 3 months life expectancy ;

You may not qualify if:

• Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drugs;
• Uncontrollable cardiovascular and cerebrovascular events , such as:
• NYHA grade 2 or above heart failure;
• Unstable angina pectoris;
• Myocardial infarction occurred within 12 months;
• Supraventricular or ventricular arrhythmia with clinical significance needs treatment or intervention;
• Cerebral hemorrhage and cerebral infarction (except for lacunar cerebral infarction without symptoms and without treatment);
• Serious cardiovascular and cerebrovascular events occurred within 12 months; Uncontrolled hypertension, i.e. systolic blood pressure\>140 mmHg or diastolic blood pressure\>90 mmHg after treatment;
• A history of arterial thrombosis or deep vein thrombosis within 6 months , or with evidence of bleeding tendency or medical history within 2 months, regardless of the severity;
• Stroke event or transient ischemic attack occurred within 12 months.
• Received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks;
• A history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.);
• A history of active immune deficiency or autoimmune diseases, including HIV positive, or others acquired or congenital immune deficiency diseases, or organ transplantation;
• Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection. A history of active tuberculosis infection ≥ 1 year should also be excluded, unless proved has been completed appropriate treatment;
• Brain metastasis or leptomeningeal metastasis;

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

MeSH Terms

Interventions

disitamab vedotin

Central Study Contacts

Yanru Qin, Doctor

CONTACT

0371-66271157; yanruqin@163.com

Yongxu Jia, Doctor

CONTACT

0371-66271156; jiayongxu111@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: July 9, 2024
• Study Start: July 6, 2024
• Primary Completion (Estimated): July 6, 2026
• Study Completion (Estimated): July 6, 2027
• Last Updated: July 9, 2024

Record last verified: 2024-07

Locations

CN (1)