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

NCT05649163 | Unknown

• 1 other identifier: DVReal-001
• Study Type: observational
• Target: 306
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HER2; Advanced Gastric Cancer; Advanced Gastroesophageal Junction Adenocarcinoma; Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Incidence, drug correlation, and severity of adverse events during the study period

  From January 2023 to January 2025

• Overall survival (OS)

  From January 2023 to January 2025

• Progression-free survival (PFS)

  From January 2023 to January 2025

• Objective response rate (ORR)

  From January 2023 to January 2025

Study Arms (3)

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

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

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

Interventions

Disitamab Vedotin DRUG

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.

Also known as: RC48

Cohort1; Cohort2; Cohort3

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Known hypersensitivity or delayed allergic reactions to certain components of the study drug or similar drugs;
• Participating in any interventional clinical trials;

Sponsors & Collaborators

• Shen Lin: lead
• RemeGen Co., Ltd.: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Interventions

disitamab vedotin

Study Officials

• Lin Shen, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Shen, MD

CONTACT

86-010-88196561; doctorshenlin@sina.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 13, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: May 1, 2025
• Last Updated: December 16, 2022

Record last verified: 2022-12

Locations

CN (1)