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Experimental drug SHR-7367 takes first step against advanced cancers

NCT ID NCT05740202

Disease control Sponsor: Shanghai Hengrui Pharmaceutical 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time

Summary

This early-stage trial tests an experimental drug called SHR-7367 in people with advanced solid tumors that have spread or cannot be removed by surgery. The main goals are to check the drug's safety, find the best dose, and see if it can shrink tumors. About 22 participants will receive the drug in escalating doses.

What this could mean

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

Active substance
an experimental drug called SHR-7367
What this could lead to
If successful, this could lead to 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 trial with only 22 participants, so the drug may prove unsafe or ineffective. Side effects and lack of tumor shrinkage are possible.

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

22 people

The number who actually took part.

Started

Mar 2023

Finished

Aug 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: 1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study; 2. Male or female aged ≥18 years and ≤75 years at the time of signing the ICF; 3. Histopathologically or cytologically documented advanced or metastatic malignancies; 4. At least 1 measurable lesion conforming to RECIST 1.1 criteria; 5. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; 6. Female and male patients of reproductive potential must agree to use highly effective contraception. Exclusion Criteria: 1. Any immunostimulants administered within 4 weeks; 2. Systemic anti-tumor therapy within 4 weeks; 3. Any investigational cancer therapy administered within 4 weeks; 4. Surgical procedures requiring general anesthesia within 4 weeks; 5. History of autoimmune diseases; 6. History of immunodeficiency; 7. Severe infections within 2 weeks prior to the first study treatment; 8. Clinically significant cardiovascular condition; 9. Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment; 10. Known history of serious allergic reactions to the investigational product or its main ingredients.

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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

Contacts and locations

Locations

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

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