New antibody drug aims to outsmart tumors by targeting two immune pathways
NCT ID NCT07623707
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a new drug called FG-B901, a bispecific antibody that targets two immune proteins (PD-L1 and CD40) to activate the immune system against tumors while reducing side effects. It is given alone or with chemotherapy to 264 adults with advanced solid tumors that have not responded to standard treatments. The main goals are to check safety, find the best dose, and see if the drug can shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FG-B901 (a bispecific antibody targeting PD-L1 and CD40)
- What this could lead to
- If successful, this could lead to a new treatment option for advanced solid tumors that are resistant to standard therapies.
- What could go wrong
- This is an early phase I/II trial, so safety and effectiveness are not yet proven. The drug may cause side effects or fail to shrink tumors.
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 264 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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Jul 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; * Able to provide tumor tissue specimens and peripheral blood samples that meet testing requirements, or provide prior test reports that meet the requirements; * ECOG performance status of 0 or 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 randomization; * Have received radiotherapy within 4 weeks prior to randomization; * Have received other anti-tumor drug therapy within 4 weeks or within 5 half-lives of the anti-tumor drug prior to randomization; * Have undergone major surgery within 4 weeks prior to randomization; * Have received any clinical study drug treatment within 4 weeks prior to randomization; * Have undergone major surgery within 4 weeks prior to randomization; * Have a history of other (non-study tumor) malignancies within 3 years prior to randomization; * Have received any organ transplant or bone marrow transplant; * Have previously received any tumor necrosis factor receptor (TNFR) agonist antibody therapy, such as anti-CD40, anti-OX40, anti-CD137, anti-CD27, anti-CD357 antibodies, etc; * Have experienced Grade ≥3 immune-related adverse events (irAEs) from prior immunotherapy; * Have a history of severe allergic reactions or are allergic to the investigational drug (FG-B901); * Have a history of central nervous system metastases and/or carcinomatous meningitis; * Have adverse reactions from prior treatments that have not recovered to CTCAE v5.0 Grade ≤1 (excluding alopecia and anemia) prior to randomization; * Have a history of severe respiratory disease; * Have experienced a clinically significant cardiac disease within 6 months before the first dose of study drug; * Have uncontrolled systemic diseases assessed by the investigator, including diabetes, hypertension, pulmonary fibrosis, interstitial lung disease, etc.; * The investigator judges the subject to have obvious active gastrointestinal bleeding; * Known history of Hepatitis C or chronic active Hepatitis B; * Have experienced systemic treatment with corticosteroids within ≤2 weeks prior to randomization; * Any other condition of the subject (e.g., psychological, geographical, or medical condition) that does not permit compliance with the study and follow-up procedures; * Are pregnant or breastfeeding;
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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
1 site. 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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Fudan University Shanghai Cancer Center
Shanghai, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First human test of BI 4060107 aims to find safe dose for Hard-to-Treat tumors
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Can a new drug shield kidneys from chemotherapy damage?
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers