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New cancer drug FH-006 enters human trials for solid tumors

NCT ID NCT06735144

Disease control Sponsor: Jiangsu HengRui Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called FH-006 in 200 people with advanced solid tumors that have not responded to standard treatments. The goal is to check the drug's safety, find the best dose, and see if it can shrink tumors. Participants receive FH-006 by IV every 2 or 3 weeks.

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 (an experimental drug given by IV)
What this could lead to
If successful, this could point toward 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 (Phase 1/2) with only 200 participants, so the drug may not work or could have serious side effects. It is not yet proven to be safe or effective.

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 200 people

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

Started

Dec 2024

Expected to finish

Dec 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. Women aged 18 to 75 (inclusive) 2. Subjects with histologically or cytologically confirmed recurrent or metastatic solid tumors who experience disease progression after standard treatment, or who do not have a standard treatment plan or are not suitable for standard treatment. 3. ECOG score is 0 or 1 4. An expected survival of ≥3 months 5. At least one target lesion according to RECIST v1.1 criteria 6. Has a good level of organ function 7. Patients voluntarily joined the study and signed informed consent Exclusion Criteria: 1. Have other malignancies within the past 5 years 2. Active central nervous system metastasis without surgery or radiotherapy 3. Presence with uncontrollable third space effusion 4. Have undergone other anti-tumor treatment within 4 weeks before the first dose 5. Has severe infection within 4 weeks before the first medication 6. Any active autoimmune disease or a history of autoimmune disease 7. A history of immune deficiency 8. Has serious cardiovascular and cerebrovascular diseases 9. Clinically significant history of lung disease 10. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I 11. Having undergone surgery on important organs within 4 weeks prior to the first use of medication 12. Used attenuated live vaccine within 28 days prior to the first use of the investigational drug 13. Presence of other serious physical or mental diseases or laboratory abnormalities

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Conditions

The condition(s) this trial relates to.

cancer

As listed by the trial registrant

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

Malignant 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

    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

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

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