A Phase 1 Study of SHR-A1811 in Patients With Selected HER2 Expressing Tumors

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04513223
• Other study ID #: SHR-A1811-I-102
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 30, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 101
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Gastric Cancer

Intervention

Drug:
• SHR-A1811
There are six pre-defined dose regimens . Subjects will be enrolled with an initial dose

Locations

Country	Name	City	State
China	Shanghai East Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DLT and the recommended Phase 2 dose (RP2D)		Subjects will be treated and observed for dose-limiting toxicity(DLT) through the end of the first cycle (Days 1-21).