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Solid TumorPhase 1/2NCT07623707

A Study of FG-B901 Monotherapy or Combination With Chemotherapy in Advanced or Metastatic Solid Tumors

A Phase 1/2 study testing FG-B901 and standard or investigator-determined chemotherapy in people with Solid Tumor, run by FutureGen Biopharmaceutical (Beijing) Co., Ltd at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

FG-B901 is a recombinant humanized IgG2 bispecific antibody targeting PD-L1 and CD40. It is designed to provide PD-L1-dependent CD40 agonism, thereby enhancing selectivity for the tumor microenvironment and reducing systemic toxicity compared with conventional CD40 agonists. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Solid Tumor
What is being tested?
FG-B901 and standard or investigator-determined chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
264 participants
Where
1 siteChina
Study dates
Jul 2026to Jul 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • 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;
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  • 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;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhaoyu Jin, Ph.D contact

010-60709130

pr@futuregenbiopharm.com

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai

    Jian Zhang, +86-021-64175590, syner2000@163.com

    Xianjun Yu, +86-021-64175590, yuxianjun@fudanpci.org

Other trials in China

About this study

Official title: An Open-Label, Multicenter Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FG-B901 Injection as Monotherapy and in Combination With Standard or Investigator-Determined Chemotherapy in Subjects With Unresectable Locally Advanced or Metastatic Solid Tumors

FG-B901 is a recombinant humanized IgG2 bispecific antibody targeting PD-L1 and CD40. It is designed to provide PD-L1-dependent CD40 agonism, thereby enhancing selectivity for the tumor microenvironment and reducing systemic toxicity compared with conventional CD40 agonists. Preclinically, FG-B901 promotes antigen-presenting cell activation and synergizes with PD-L1/PD-1 blockade to potentiate T-cell anti-tumor immunity. This is an open-label, multicenter phase I/II trial in subjects with unresectable locally advanced or metastatic solid tumors. The primary objectives are to evaluate the safety, tolerability, and pharmacokinetics of FG-B901 as monotherapy and in combination with chemotherapy. Secondary objectives include preliminary anti-tumor efficacy (e.g., objective response rate, disease control rate, progression-free survival, and overall survival).

Conditions
Solid Tumor
Being tested
FG-B901, standard or investigator-determined chemotherapy
Keywords
CD40 agonist

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FG-B901Drug

    Accelerated titration method, IV infusion Q3W; Adaptive BOIN design, IV infusion Q3W. (21-day cycles)

  • standard or investigator-determined chemotherapyDrug

    standard or investigator-determined chemotherapy depending on the type of tumors.

Study groups in NCT07623707
Study groupRoleWhat they receive
Monotherapy Dose Escalation CohortExperimentalNine dose levels of FG-B901 will be tested according to an accelerated titration method followed by a adaptive BOIN design.
Receives: Drug: FG-B901
Monotherapy Dose Expansion CohortExperimentalOnce the effective dose has been determined, 1~2 expansion cohorts will be opened to evaluate the efficacy and safety of the selected dose.
Receives: Drug: FG-B901
Combined-therapy Dose Escalation CohortExperimentalThree dose levels of FG-B901 will be tested according to an accelerated titration method followed by a adaptive BOIN design.
Receives: Drug: FG-B901; Drug: standard or investigator-determined chemotherapy
Combined-therapy Dose Expansion CohortExperimentalOnce the effective dose has been determined, 1~2 expansion cohorts will be opened to evaluate the efficacy and safety of the selected dose.
Receives: Drug: FG-B901; Drug: standard or investigator-determined chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety assessed by Adverse Events (AEs)

    An AE is any adverse medical event that occurs during a clinical study, whether or not related with medicinal product, including signs, symptoms, abnormal laboratory test results and diseases. The incidence and severity of AEs during the clinical study are recorded and analyzed.

    Measured: Up to 24 months

  2. Maximum Tolerated Dose (MTD)

    MTD

    Measured: 21 days

Secondary outcomes (8)

  1. Objective Response Rate (ORR)

    ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation per RECIST 1.1.

    Measured: Up to 24 months

  2. Disease control rate (DCR)

    DCR is defined as the proportion of participants who have a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) as assessed by investigator evaluation per RECIST 1.1.

    Measured: Up to 24 months

  3. Progression Free Survival (PFS)

    PFS is defined as the duration from randomization to the first imaging confirmation of progressive disease per RECIST 1.1 by investigator evaluation or death due to any cause (whichever occurs first).

    Measured: Up to 24 months

  4. Duration Of Response (DOR)

    DOR is defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by investigator evaluation per RECIST 1.1 or death due to any cause (whichever occurs first).

    Measured: Up to 24 months

  5. Overall Survival (OS)

    OS is defined as the time from randomization to deathdue to any cause.

    Measured: Up to 24 months

  6. Maximum measured plasma concentration of FG-B901

    Cmax

    Measured: Up to 24 months

  7. Time to maximum plasma concentration of FG-B901

    Tmax

    Measured: Up to 24 months

  8. Half-life of FG-B901

    T1/2

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2026
  2. Study startJul 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
264 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07623707
Sponsor's protocol ID
FG-B901-01
Status last verified
May 2026
First submitted
29 May 2026
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing FG-B901 and standard or investigator-determined chemotherapy in people with Solid Tumor, run by FutureGen Biopharmaceutical (Beijing) Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhaoyu Jin, Ph.D (010-60709130, pr@futuregenbiopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety assessed by Adverse Events (AEs) (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07623707.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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