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New hope for advanced cancer: experimental drug SHR-1681 enters human trials

NCT ID NCT06737731

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests an experimental drug called SHR-1681 in 300 people with advanced solid tumors that have not responded to standard treatments. The goal is to find a safe dose and see if the drug can shrink tumors. It is an early-stage trial, so the main focus is on safety and how the drug behaves in 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-1681 (an experimental drug given by injection)
What this could lead to
If it works, this could lead to a new treatment option for people with advanced solid tumors who have run out of standard therapies.
What could go wrong
This is an early-phase trial, so the drug may not be effective or could have serious side effects. Success in this small group may not apply to all patients.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 300 people

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

Started

Jan 2025

Expected to finish

Jul 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. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form; 2. Subjects with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently; 3. Have at least one measurable tumor lesion per RECIST v1.1; 4. ECOG performance score of 0-1; 5. Life expectancy ≥ 3 months; 6. Adequate bone marrow and organ function. Exclusion Criteria: 1. Subjects with active central nervous system metastases or meningeal metastases; 2. History of serious cardiovascular and cerebrovascular diseases; 3. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; 4. Severe infection within 4 weeks prior to the first dose; 5. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug; 6. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

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Conditions

The condition(s) this trial relates to.

cancer neoplasm

As listed by the trial registrant

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

Malignant 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

  • Shanghai Dongfang Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200433, China

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