Can a new drug shrink tumors that resist other treatments?

NCT ID NCT07136142

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests an experimental drug called FH-006 in 150 people with advanced solid tumors that cannot be removed by surgery or have spread. The goal is to see if FH-006 is safe, tolerable, and can shrink tumors. Researchers will measure how the drug moves through the body and track any side effects. The study is open to adults with measurable tumors who are otherwise in good health.

What this could mean

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

Active substance
FH-006 for injection, an experimental drug
What this could lead to
If FH-006 proves safe and effective, it could become a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is an early-phase trial, so FH-006 may not work as hoped or may cause side effects. The results will only show preliminary signs of effectiveness, not a proven cure.

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 150 people

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

Started

Sep 2025

Expected to finish

Feb 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 with ability to understand and voluntarily agree to participate by giving written informed consent for the study. 2. Patients with unresectable recurrent or metastatic solid tumors. 3. There is at least one lesion that could be measured. 4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1. 5. Adequate organ functions as defined. 6. Life expectancy ≥ 3 months. Exclusion Criteria: 1. Patients with known active central nervous system (CNS) metastases. 2. Subjects who had other malignancy in five years before the first dose. 3. Patients with tumor-related pain that can not be controlled as determined. 4. Patients with serious cardiovascular and cerebrovascular diseases. 5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion. 6. Patients with severe infections. 7. History of immunodeficiency. 8. History of autoimmune diseases. 9. Unresolved CTCAE Grade \>1 toxicity attributed to any prior anti-tumor therapy. 10. Active infection. 11. Pregnant or nursing women. 12. 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.

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

    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

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Tianjin Medical Unversity Cancer Institute & Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300181, China

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