Back to resultsA Phase 1 Study of SHR-A1811 in Patients With Selected HER2 Expressing Tumors
Primary Purpose
Gastric Cancer, Colorectal Cancer
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR-A1811
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- Has a pathologically or cytologically documented advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma and colorectal cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- At least one evaluable or measurable lesion should be present and identified according to Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1.
- Has an ECOG PS 0-1.
- Has a life expectancy of ≥ 3 months.
- Has adequate organ function
Exclusion Criteria:
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
- Has received HER2 antibody drug conjugates,.
- Central nervous system metastasis or meningeal metastasis with clinical symptoms
- Has active infection requiring systemic treatment.
Sites / Locations
- Shanghai East HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SHR-A1811
Arm Description
Outcomes
Primary Outcome Measures
DLT and the recommended Phase 2 dose (RP2D)
Secondary Outcome Measures
Full Information
NCT ID
NCT04513223
First Posted
August 12, 2020
Last Updated
May 13, 2022
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04513223
Brief Title
A Phase 1 Study of SHR-A1811 in Patients With Selected HER2 Expressing Tumors
Official Title
Safety, Tolerability, Pharmacokinetics, and Antitumour Activity of SHR-A1811, in Patients With HER2-expressing Advanced Gastric or Gastroesophageal Junction Adenocarcinoma and Colorectal Cancer: a Phase 1 Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a single arm, open-label, dose escalation, PK expansion and efficacy expansion study of phase I. The purpose of this study is to assess the tolerability, safety, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2-expressing advanced gastric or gastroesophageal junction adenocarcinoma and colorectal cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
114 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR-A1811
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SHR-A1811
Intervention Description
There are six pre-defined dose regimens . Subjects will be enrolled with an initial dose
Primary Outcome Measure Information:
Title
DLT and the recommended Phase 2 dose (RP2D)
Time Frame
Subjects will be treated and observed for dose-limiting toxicity(DLT) through the end of the first cycle (Days 1-21).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has a pathologically or cytologically documented advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma and colorectal cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
At least one evaluable or measurable lesion should be present and identified according to Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1.
Has an ECOG PS 0-1.
Has a life expectancy of ≥ 3 months.
Has adequate organ function
Exclusion Criteria:
Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
Has received HER2 antibody drug conjugates,.
Central nervous system metastasis or meningeal metastasis with clinical symptoms
Has active infection requiring systemic treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qianna Zhan
Phone
+0518-82342973
Email
Qianna.zhan@hengrui.com
Facility Information:
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Li, Doctor
Phone
021-38804518
Email
lijin@csco.org.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Phase 1 Study of SHR-A1811 in Patients With Selected HER2 Expressing Tumors
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