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

NCT06572319 | Recruiting Phase 1

• 1 other identifier: IRB-2024-278
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a single center, single arm, open label clinical study aimed at evaluating the efficacy and safety of the combination therapy of Disitamab Vedotin and trastuzumab in the treatment of advanced HER-2 positive gastric/gastroesophageal junction tumors

Conditions

HER2-positive Gastric Cancer; HER2-positive Gastroesophageal Junction Adenocarcinoma

Keywords

HER-2; ADC; Disitamab Vedotin; trastuzumab

Outcome Measures

Primary Outcomes (1)

• Objective response rate(ORR)

  he number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%)

  12 months

Secondary Outcomes (4)

• Overall survival (OS)

  up to 36 months

• Progression-free survival (PFS)

  up to 12 months

• Disease control rate (DCR)

  up to 12 months

• Incidence of Treatment-Emergent 3/4 Adverse Events

  up to 12 months after enrollment or study close

Study Arms (1)

Phase Ⅰ/Ⅱ： Disitamab Vedotin(RC48) Plus Tratuzumab

EXPERIMENTAL

Dose exploration： Disitamab Vedotin（RC48）: 2.5mg/kg，ivgtt，D1, every 2 weeks for a treatment cycle. Tratuzumab:"3+3"Design，1mg/kg Q2W，2.5mg/kg Q2W，4mg/kg Q2W Dose expansion： Disitamab Vedotin（RC48）: 2.5mg/kg，ivgtt，D1, every 2 weeks for a treatment cycle. Tratuzumab: RP2D

Drug: Disitamab Vedotin(RC48) Plus Tratuzumab

Interventions

Disitamab Vedotin(RC48) Plus Tratuzumab DRUG

Disitamab Vedotin: 2.5mg/kg，ivgtt，D1, every 2 weeks for a treatment cycle. Tratuzumab: RP2D，ivgtt，D1, every 2 weeks for a treatment cycle.

Phase Ⅰ/Ⅱ： Disitamab Vedotin(RC48) Plus Tratuzumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Sign the informed consent form; 2.18-75 years old (including 18 years old, excluding 75 years old), gender not limited; 3. The pathological histology confirmed by pathology is adenocarcinoma of the gastric/gastroesophageal junction; 4. HER2 positive tumor criteria (primary tumor or metastatic lesion, HER2 positive is defined as IHC 2+/FISH+(HER2: CEP17 ratio ≥ 2.0) or IHC (3+). Using the criteria for interpreting HER2 in gastric cancer 5. Recurrent or metastatic diseases that cannot be surgically treated, with at least one measurable lesion (RECIST 1.1 criteria) in the subject and an estimated survival time of at least 12 weeks; 6. ECOG score ranges from 0 to 1 points; 7. At least first-line systemic therapy has failed (regardless of whether it includes anti-HER2 monoclonal antibody therapy); 8. Having sufficient bone marrow, liver and kidney function:
• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets ≥ 90 × 109/L, or
• hemoglobin ≥ 9g/dL;
• ALT or AST levels without liver metastasis are less than 2.5 times the upper limit of the normal range; When liver metastasis occurs, ALT or AST is less than 5 times the upper limit of the normal range; Serum bilirubin is 1.5 times lower than the upper limit of the normal reference range;
• Serum creatinine is lower than 1.5 times the upper limit of the normal reference range or creatinine clearance rate is ≥ 40ml/min; 9. Women of childbearing age and their spouses are willing to use effective contraceptive methods within the last 7 months of treatment.

You may not qualify if:

• Known to be allergic to the received therapeutic drugs or excipients;
• Baseline LVEF\<50% (measured by echocardiography or MUGA);
• Previously received treatment with anti-HER2 ADC drugs;
• Individuals who have undergone systemic immunotherapy, biologic therapy, or participated in any clinical drug trials within the past 2 weeks;
• Those who have undergone surgery within 3 weeks before the start of the experimental treatment and have not fully recovered;
• Patients with uncontrolled central nervous system (CNS) metastases or epilepsy requiring medication treatment;
• Serious systemic diseases. Such as infected or uncontrolled diabetes;
• Suffering from other malignant tumors within 5 years, except for non melanoma skin cancer and cervical carcinoma in situ;
• Clinically symptomatic active coronary heart disease, cardiomyopathy, or congestive heart failure, NYHA III-IV; uncontrolled hypertension (systolic blood pressure\>180 mmHg or diastolic blood pressure\>100 mmHg), clinically symptomatic heart valve disease, or high-risk arrhythmia;
• Patients receiving long-term or high-dose corticosteroid treatment (inhaled steroids or short-term oral steroids are allowed to resist vomiting or promote appetite)
• Individuals without legal capacity, those whose medical or ethical reasons affect the continuation of research;
• Pregnant and lactating female patients, or those who wish to become pregnant during treatment;
• Uncontrolled pleural and peritoneal effusion;
• There is a persistent infection of\>level 2 (CTC-AE 4.0); Wounds, ulcers, or fractures that cannot heal, or patients with a history of organ transplantation;
• There are unresolved toxicity levels\>1 caused by any previous treatment/procedure (CTC-AE 4.0, excluding hair loss, anemia, and hypothyroidism);

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Study Officials

• Jieer Ying, M.D.

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jieer Ying, M.D.

CONTACT

13858195803; jieerying@aliyun.com

Jieer Ying, M.D.

CONTACT

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: MD

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 27, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)