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New drug SHR-A1811 targets HER2-Positive cancers in early trial

NCT ID NCT04513223

Disease control Sponsor: Jiangsu HengRui Medicine Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested a new drug called SHR-A1811 in 101 people with advanced stomach or colorectal cancers that have a specific protein called HER2. The main goals were to check the drug's safety, find the best dose, and see early signs of tumor shrinkage. Participants had cancers that no longer responded to standard treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SHR-A1811 (a targeted drug that attacks cancer cells with a specific protein called HER2)
What this could lead to
If successful, this could point toward a new treatment option for people with advanced stomach or colorectal cancers that have the HER2 protein and have not responded to standard therapies.
What could go wrong
This is an early Phase 1 trial with only 101 participants, so the main goals are safety and finding the right dose—not proving the drug works. The drug may cause side effects or fail to shrink tumors in later, larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

101 people

The number who actually took part.

Started

Mar 2021

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal carcinoma colorectal neoplasm gastric adenocarcinoma gastric cancer gastric neoplasm gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer Gastric cancer

Contacts and locations

Locations

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, Shanghai, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.