Solid Tumor
Conditions
Keywords
CD40 agonist
Brief 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. 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).
Interventions
DRUGFG-B901
Accelerated titration method, IV infusion Q3W; Adaptive BOIN design, IV infusion Q3W. (21-day cycles)
DRUGstandard or investigator-determined chemotherapy
standard or investigator-determined chemotherapy depending on the type of tumors.
Sponsors
FutureGen Biopharmaceutical (Beijing) Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessed by Adverse Events (AEs) | Up to 24 months | 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. |
| Maximum Tolerated Dose (MTD) | 21 days | MTD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to 24 months | 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. |
| Disease control rate (DCR) | Up to 24 months | 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. |
| Progression Free Survival (PFS) | Up to 24 months | 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). |
| Duration Of Response (DOR) | Up to 24 months | 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). |
| Overall Survival (OS) | Up to 24 months | OS is defined as the time from randomization to deathdue to any cause. |
| Maximum measured plasma concentration of FG-B901 | Up to 24 months | Cmax |
| Time to maximum plasma concentration of FG-B901 | Up to 24 months | Tmax |
| Half-life of FG-B901 | Up to 24 months | T1/2 |
Countries
China
Contacts
CONTACTZhaoyu Jin, Ph.D
Outcome results
None listed