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New injectable drug tested for safety in Hard-to-Treat solid tumors

NCT ID NCT07830199

NEW 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 trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are running a phase 1 trial of SHR-4595, an experimental injectable drug, in adults with advanced solid tumors that have not responded to standard treatments. The study checks how safe and tolerable the drug is, how the body processes it, and what dose might work best for later trials. About 208 participants will receive different doses of SHR-4595, and doctors will track side effects and tumor responses.

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 injectable drug called SHR-4595
What this could lead to
If SHR-4595 proves safe and tolerable, researchers could move it into larger phase 2 trials to see whether it shrinks tumors or slows their growth.
What could go wrong
This is a phase 1 trial, so its main goal is safety, not cure. The drug may cause side effects, and early-phase treatments often fail to help patients or never reach later testing.

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 208 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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 years and older

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: A subject must satisfy all of the following criteria to be considered for inclusion in the study. 1. The subjects voluntarily joined the study and signed the ICF. 2. Measurable disease, as defined by RECIST v1.1. 3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1. 4. Life expectancy ≥ 12 weeks. 5. Subjects with cytologically or histologically confirmed advanced solid tumors who have failed or are intolerant to standard therapy, have no standard therapy, or refuse standard therapy. Exclusion Criteria: A subject who meets any of the following criteria will be excluded from study entry. 1. Symptomatic, untreated or active central nervous system metastases. 2. Have uncontrolled or severe cardiovascular disease Have clinical symptoms or disease of the heart that are not well controlled. 3. With any active autoimmune disease or history of autoimmune disease. 4. Patients with active hepatitis B or hepatitis C. 5. Severe infections prior to initiation of study treatment.

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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.

Solid tumor

How to take part

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

  1. The places running it

    2 sites. 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

  • Cancer Hospital of Dalian University of Technology (Liaoning Cancer Hospital & Institute)

    Shenyang, Liaoning, 110042, China

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300060, China

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