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New hope for stomach cancer: drug combo targets tumors

NCT ID NCT05980481

Disease control Sponsor: RemeGen 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug (RC48-ADC) combined with immunotherapy (toripalimab) and either chemotherapy or another targeted drug (trastuzumab) as a first treatment for people with advanced stomach cancer. About 201 adults aged 18-75 with HER2-positive or HER2-negative stomach cancer that cannot be removed by surgery or has spread will participate. The goal is to see if these combinations shrink tumors and help control the disease.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 201 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Oct 2026

An estimate. End dates often move.

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: * Voluntary agreement to provide written informed consent. * Age:18-75 years（including 18 and 75）. * Predicted survival ≥ 12 weeks. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Adequate organ function. * All subjects must have inoperable, advanced or metastatic gastric or or gastroesophageal adenocarcinoma. * Subject must be previously untreated with systemic treatment; Subject that received neoadjuvant chemotherapy with recurrence \>6 months from completion of therapy are permitted; * HER2-expressing status determined by laboratory to be IHC 1+, 2+ or 3+ or IHC0. Exclusion Criteria: * Active central nervous system (CNS) metastases. * Known active hepatitis B, active hepatitis C, or human immunodeficiency virus (HIV) infection. * History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, thyroid cancer ,etal. * Known hypersensitivity to antibody-drug conjugate(ADC) or PD-(L)1 or any of its components. * Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.

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Conditions

The condition(s) this trial relates to.

gastric cancer gastric neoplasm

As listed by the trial registrant

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

Gastric cancer

Contacts and locations

Locations

  • Beijing Cancer Hospital

    Beijing, China

More trials for these conditions

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