NCT04513223

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P75+ for phase_1 gastric-cancer

Timeline
Completed

Started Mar 2021

Typical duration for phase_1 gastric-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

March 30, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2025

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

August 12, 2020

Last Update Submit

February 4, 2026

Conditions

Gastric CancerColorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • 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).

Study Arms (1)

SHR-A1811

EXPERIMENTAL
Drug: SHR-A1811

Interventions

SHR-A1811DRUG

There are six pre-defined dose regimens . Subjects will be enrolled with an initial dose

SHR-A1811

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, Shanghai, China

Location

MeSH Terms

Conditions

Stomach NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 14, 2020

Study Start

March 30, 2021

Primary Completion

March 28, 2025

Study Completion

March 28, 2025

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations

CN(1)