Double-Drug attack on Hard-to-Treat cancers
NCT ID NCT07704866
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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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.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Harbin Medical University Cancer Hospital
Ha’erbin, China
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The First Hospital of China Medical University
Shenyang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A single arm, open label, dose-escalation phase i and dose-expansion phase IIa clinical study to evaluate the feasibility, safety, and efficacy of allogeneic chimeric antigen receptor (CAR) Gamma-Delta t cells CAR001 in subjects with Relapsed/Refractory solid tumors
- Can an antidepressant calm Chemotherapy's nerve pain?
- A new imaging agent aims to make solid tumors visible on PET scans
- Can a radioactive antibody seek out and destroy Hard-to-Treat tumors?
- Can a platform trial match the right drug combo to each tumor?
- Can immune cell infusions help fight solid tumors?