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New cancer drug SHR-3821 enters first human trial

NCT ID NCT06618651

Disease control Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage study is testing a new drug called SHR-3821 in 162 people with advanced solid tumors that have not responded to standard treatments. The main goals are to check the drug's safety, find the right dose, and see if it can shrink tumors. Participants will receive the drug by injection, and researchers will monitor them closely for side effects and how the drug moves through the body.

What this could mean

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

Active substance
SHR-3821 injection
What this could lead to
If this early trial shows promise, it could point toward a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is a very early Phase 1 study with only 162 participants, so the drug may not prove safe or effective. Side effects are unknown, and many early-stage cancer drugs do not advance to later trials.

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

About 162 people

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

Started

Nov 2024

Expected to finish

Jan 2027

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: 1. Voluntary participation and written informed consent. 2. 18-75 years older, no gender limitation. 3. Eastern Cooperative Oncology Group (ECOG) score: 0-1. 4. With a life expectancy ≥ 3 months. 5. Pathologically diagnosed advanced solid tumor. 6. Be able to provide fresh or archived tumour tissue. 7. At least one measurable lesion according to RECIST v1.1. 8. Adequate bone marrow reserve and organ function. 9. Contraception is required during the trial. Exclusion Criteria: 1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis. 2. Uncontrollable tumor-related pain. 3. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms. 4. Received systemic antitumor therapy before the first dose. 5. Treated with similar target therapy as SHR-3821 before the first dose. 6. Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment. 7. Unresolved CTCAE 5.0\>=grade 2 toxicities from previous anticancer therapy. 8. Current or History of ILD. 9. Active severe digestive disease. 10. Previous or co-existing malignancies. 11. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-3821. 12. Active hepatitis B or active hepatitis C. 13. Other inappropriate situation considered by the investigator.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

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

Advanced solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • West China Hospital of Sichuan Hospital

    RECRUITING

    Chengdu, Sichuan, 610000, China

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