Real-world Study of HER2-overexpressed Advanced Solid Tumors After Progression of First-line Standard Therapy

A Non-interventional, Multi-cohort, Multi-center, Prospective Real-world Study of Treatment Pattern and Clinical Outcomes in Patients With HER2-overexpressed Advanced Solid Tumors After Progression of First-line Standard Therapy

The goal of this observational study is to learn about in describe treatment pattern and clinical outcomes in patients with HER2-overexpressed advanced solid tumors after progression of first-line standard therapy. The main questions it aims to answer are:

• To evaluate the real-world safety and efficacy of Disitamab Vedotin in second-line and beyond treatment of advanced solid tumors with HER2 overexpression
• To describe the treatment pattern and clinical outcomes of patients with advanced gastric cancer with HER2 overexpression in real world Settings after the failure of first-line standard therapy.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Tumor; Advanced Gastric Cancer; Advanced Gastroesophageal Junction Adenocarcinoma; HER2
• Intervention / Treatment: Drug: Disitamab Vedotin

Detailed Description

This is a prospective, non-interventional, multi-cohort, multi-center real-world study to evaluate the treatment pattern and clinical outcomes of patients with advanced HER2-overexpressed solid tumors after the progression of first-line standard therapy. Enrolled subjects in this study were treated according to the treatment protocol established by physicians according to clinical routine. The tests, examinations and drug use in the study were consistent with the requirements of the clinical practice. No additional tests, examinations and drugs were generated from the data collection in this study. The study included 306 patients with HER2-overexpressed advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma and other advanced solid tumors who had failed previous first-line standard therapy. HER2 overexpression was defined as IHC2+ or IHC3+ detected by immunohistochemistry (IHC) (either primary or metastatic tumor tissue).

• Study Type: Observational
• Enrollment (Anticipated): 306

Contacts and Locations

• Study Contact: Name: Lin Shen, MD; Phone Number: 86-010-88196561; Email: doctorshenlin@sina.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
      • Contact: Lin Shen, MD; Phone Number: 86-010-88196561; Email: doctorshenlin@sina.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced solid tumors with HER2 overexpression after previous first-line standard therapy failure

Description

Inclusion Criteria:

• Signing informed consent and agreeing to comply with study requirements;
• Age ≥18 years old, gender unlimited;
• ECOG physical status 0-2 points;
• Patients with locally advanced or metastatic solid tumors confirmed histologically or cytologically;Cohort1-2 cohort: patients who had received at least previous first-line standard therapy (HER2 IHC3+ or IHC2+/FISH+ patients with first-line trastuzumab (or its biosimilar) combined with chemotherapy (fluorouracil and/or platinum-based chemotherapy);IHC2+/FISH- patients with first-line Immunotherapy combined with chemotherapy (fluorouracil and/or platinum-based chemotherapy) or chemotherapy alone);In Cohort3 cohort, patients received at least the standard first-line treatment clearly recommended by the guidelines. Patients with clear disease progression confirmed by the investigator or documented history.
• HER2 overexpression was defined as 2+ or 3+ immunohistochemistry (both primary and metastatic tumor tissue were acceptable), and previous patient test results (confirmed by the investigator) or center test results were acceptable.
• Have measurable or evaluable lesions according to RECIST1.1 criteria;
• The investigator evaluated that the patients would benefit from the study treatment;
• Good compliance, willing and able to follow the trial and follow-up procedures;
• Have traceable patient medical records.

Exclusion Criteria:

• Known hypersensitivity or delayed allergic reactions to certain components of the study drug or similar drugs;
• Participating in any interventional clinical trials;
• The investigator assessed inappropriate inclusion.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort1; Cohort1: About 186 patients with histologically or cytologically confirmed gastric/gastroesophageal junction (GEJ) adenocarcinoma with HER2 overexpression who received a regimen containing Disitamab Vedotin;	Drug: Disitamab Vedotin; Cohort 1: received a regimen containing Disitamab Vedotin. Cohort 2: received an investigator-selected regimen in addition to Disitamab Vedotin; Treatment options selected by the investigator: no treatment containing Disitamab Vedotin was given, and other systemic antitumor agents (including chemotherapy, such as paclitaxel, docetaxel, irinotecan, and fluorouracil) were selected by the investigator in line with clinical practice. Targeted therapy: such as apatinib, ramucirumab; Combination therapy: ramucirumab + paclitaxel; Immune checkpoint inhibitors such as PD1/PD-L1); Cohort 3: receiving a regimen containing Disitamab Vedotin.; Other Names: RC48
Cohort2; Cohort2: About 80 patients with histologically or cytologically confirmed HER2-overexpressed gastric cancer /GEJ adenocarcinoma who received an investigator-selected regimen in addition to Disitamab Vedotin;	Drug: Disitamab Vedotin; Cohort 1: received a regimen containing Disitamab Vedotin. Cohort 2: received an investigator-selected regimen in addition to Disitamab Vedotin; Treatment options selected by the investigator: no treatment containing Disitamab Vedotin was given, and other systemic antitumor agents (including chemotherapy, such as paclitaxel, docetaxel, irinotecan, and fluorouracil) were selected by the investigator in line with clinical practice. Targeted therapy: such as apatinib, ramucirumab; Combination therapy: ramucirumab + paclitaxel; Immune checkpoint inhibitors such as PD1/PD-L1); Cohort 3: receiving a regimen containing Disitamab Vedotin.; Other Names: RC48
Cohort3; Cohort3: Approximately 40 patients with other advanced solid tumors histologically or cytologically confirmed with HER2-overexpression and receiving a regimen containing Disitamab Vedotin.	Drug: Disitamab Vedotin; Cohort 1: received a regimen containing Disitamab Vedotin. Cohort 2: received an investigator-selected regimen in addition to Disitamab Vedotin; Treatment options selected by the investigator: no treatment containing Disitamab Vedotin was given, and other systemic antitumor agents (including chemotherapy, such as paclitaxel, docetaxel, irinotecan, and fluorouracil) were selected by the investigator in line with clinical practice. Targeted therapy: such as apatinib, ramucirumab; Combination therapy: ramucirumab + paclitaxel; Immune checkpoint inhibitors such as PD1/PD-L1); Cohort 3: receiving a regimen containing Disitamab Vedotin.; Other Names: RC48

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of grade 3 and above adverse events associated with Disitamab Vedotin treatment during the study period.	The incidence of grade 3 and above adverse events associated with Disitamab Vedotin treatment during the study period.	From January 2023 to January 2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence, drug correlation, and severity of adverse events during the study period	Incidence, drug correlation, and severity of adverse events during the study period	From January 2023 to January 2025
Overall survival (OS)	Time from the start of administration to death from any cause	From January 2023 to January 2025
Progression-free survival (PFS)	The first objective record of disease progression or death from any cause (whichever occurs first) occurred after patients were enrolled and given the drug	From January 2023 to January 2025
Objective response rate (ORR)	Refers to the proportion of patients with an optimal overall response rating of CR or PR	From January 2023 to January 2025

Collaborators and Investigators

• Sponsor: Shen Lin
• Collaborators: RemeGen Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 5, 2022
• First Posted (Estimate): December 13, 2022

Study Record Updates

• Last Update Posted (Estimate): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: DVReal-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No