Double-Drug attack on Hard-to-Treat cancers

NCT ID NCT07704866

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This study tests a combination of two experimental drugs, FG-M108 and FG-B901, in people with advanced solid tumors that have a specific marker called Claudin 18.2. Participants must have tumors that have worsened despite standard treatments or for which no standard therapy exists. The trial aims to find a safe dose and see if the combination can shrink tumors or slow their growth.

What this could mean

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

Active substance
two experimental drugs called FG-M108 and FG-B901
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is an early-phase trial with a small number of participants, so the drugs may not prove effective or may cause significant side effects. The results may not apply to all tumor types.

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 120 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Feb 2029

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: * Voluntarily sign the informed consent form, understand the study, are willing to comply with and have the ability to complete all trial procedures; * Age 18-75 years (inclusive), any gender; * Have histologically or cytologically confirmed locally advanced or metastatic solid tumors, and have failed standard therapy, or are intolerant to standard therapy, or for whom standard therapy is not available; * CLDN18.2 positive (defined as ≥10% of tumor cells showing membrane staining ≥1+ by central laboratory IHC) * ECOG 0-1 * Expected survival ≥3 months; * Have at least one measurable tumor lesion according to RECIST 1.1 criteria; * Adequate cardiac, bone marrow, liver, renal function; Exclusion Criteria: * Have received a live vaccine within 3 months prior to the first dose; * Received radiotherapy within 4 weeks before the first dose * Received Chinese herbal medicine with antitumor indications within 2 weeks before the first dose * Previously received any therapy targeting CLDN18.2 * History of other malignancies within 3 years before the first dose * Experienced Grade ≥3 immune-related adverse events (irAEs) from prior immunotherapy or discontinued immunotherapy due to irAEs, or have irAEs from prior immunotherapy that the investigator judges to still have clinical impact * Toxicity from prior antitumor therapy has not recovered to NCI CTCAE v5.0 Grade 0-1 * History of severe allergic reactions, or hypersensitivity, or intolerance to any known component of the investigational products or other monoclonal antibodies * Have brain or leptomeningeal metastases with symptoms * Presence of clinically symptomatic body cavity effusions (pleural effusion, ascites, pericardial effusion, etc.) requiring local therapy or repeated drainage, or effusions that are poorly controlled per investigator judgment * Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases * Clinically uncontrolled diseases such as diabetes, thyroid disorders (hormone replacement therapy does not affect enrollment), or other severe systemic diseases requiring systemic treatment * Active or progressive infection requiring systemic treatment within 2 weeks before the first dose * Known or suspected active autoimmune disease requiring systemic treatment * Pregnant or breastfeeding female participants * Known history of Hepatitis C or chronic active Hepatitis B

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Claudin 18.2 are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

  • Harbin Medical University Cancer Hospital

    Ha’erbin, China

  • The First Hospital of China Medical University

    Shenyang, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.