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New cancer drug SPGL008 enters first human tests

NCT ID NCT07038005

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing a new biologic drug called SPGL008 in 96 adults with advanced solid tumors that have spread or cannot be removed. The main goals are to find a safe dose and check for side effects. The drug is given either through a vein or under the skin. This is a Phase 1 study, so it is too early to know if the drug works against cancer.

What this could mean

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

Active substance
SPGL008 (a biologic drug)
What this could lead to
If safe and effective, SPGL008 could become a new treatment option for advanced cancers that have not responded to other therapies.
What could go wrong
This is a very early Phase 1 trial focused on safety and dosing, not on curing cancer. Many drugs fail at this stage, and side effects are unknown. Results may not apply to all cancer types.
Why investors are watching

3SBio Inc. is watching a Phase 1 trial run by its subsidiary, Shenyang Sunshine Pharmaceutical, that tests the safety and early signs of effectiveness of the drug SPGL008 in 96 patients with advanced tumors. For a small-cap company, this early-stage readout matters because it is the first test of whether SPGL008 works well enough in people to justify further development. A clear safety signal and any sign of tumor control could make this drug a more valuable part of 3SBio's pipeline.

If it works: If SPGL008 shows acceptable safety and hints of disease control, 3SBio could advance the drug to later trials, which might strengthen its position in cancer treatment. Positive early data could also raise confidence in the company's research capabilities.

If it fails: Phase 1 trials often fail to show enough safety or benefit, and SPGL008 could be no exception. A poor result or a delay in the readout could set back the drug's development and reduce the value of this part of 3SBio's business.

AI-written from the trial record. Speculative, and not investment advice.

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 96 people

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

Started

Jul 2025

Expected to finish

Jun 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. Males and/or females, 18-75 years old; 2. Histologically and/or cytologically documented advanced or metastatic malignant Tumors; 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 4. Expected survival \>=3 months; 5. Signed informed consent form. Exclusion Criteria: 1. Known uncontrolled or symptomatic central nervous system metastatic disease; 2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI-CTCAE\] v.5.0); 3. Inadequate organ or bone marrow function; 4. Pregnant or breast-feeding woman; 5. Known allergies, hypersensitivity, or intolerance to SPGL008.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Chongqing University Cancer Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, 400030, China

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