This is a phase 1a/1b, open-label, multicenter, dose-escalation and dose-expansion study evaluating the safety, tolerability, antitumor activity, pharmacokinetics, and pharmacodynamics of FXB0871 monotherapy in adults with selected locally advanced or metastatic solid tumors. In Part Ia, participants with selected solid tumors that have progressed after, are intolerant to, or are not suitable for standard therapy will receive FXB0871 in dose-escalation cohorts to determine the maximum tolerated dose and/or recommended phase 2 dose. In Part Ib, participants with PD-(L)1-resistant non-small cell lung cancer or hepatocellular carcinoma will receive FXB0871 in dose-expansion cohorts to further evaluate antitumor activity, safety, and dose optimization.
Signed informed consent.
Age ≥18 years.
Histologically confirmed selected locally advanced or metastatic solid tumor with progression on, intolerance to, or no suitable standard therapy.
ECOG performance status 0 or 1.
Systemic anti-cancer therapy, major surgery, or radical radiotherapy within 4 weeks before first dose.
Prior treatment with IL-2, IL-15, or IL-7.
Active autoimmune disease requiring systemic treatment or immunodeficiency.
Systemic corticosteroids (≥10 mg/day prednisone equivalent) or other immunosuppressive therapy within 28 days before first dose, with limited protocol-defined exceptions.
Parallel
Intervention1：FXB0871
Biological/VaccineFXB0871 is administered by intravenous infusion at pre-determined dose level in Part Ia every 2 weeks. Treatment may continue for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met.
Intervention2：FXB0871
Biological/VaccineFXB0871 is administered by intravenous infusion at pre-determined dose level in Phase Ib every 2 weeks. Treatment may continue for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met.
Intervention3：FXB0871
Biological/VaccineFXB0871 is administered by intravenous infusion at pre-determined dose level in Phase Ib every 2 weeks. Treatment may continue for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met.
Intervention4：FXB0871
Biological/VaccineFXB0871 is administered by intravenous infusion at pre-determined dose level in Phase Ib every 2 weeks. Treatment may continue for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met.
Incidence and severity of dose-limiting toxicities (DLTs) in Phase Ia
Percentage of participants with protocol-defined DLTs during the DLT observation period in the dose-escalation phase
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), AEs leading to dose delay/interruption/reduction/treatment discontinuation in Phase Ia
Safety assessed by the incidence of treatment-emergent adverse events, serious adverse events, AEs leading to dose delay/interruption/reduction/treatment discontinuation in Phase Ia.
Objective response rate (ORR) in Phase Ib
ORR defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) per RECIST v1.1 in Phase Ib.
Objective response rate (ORR) in Phase Ia
Objective response rate (ORR), defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR), as assessed per RECIST v1.1 in Phase Ia.
Disease control rate (DCR) in Phase Ia
Disease control rate (DCR), defined as the proportion of participants with a best overall response of CR, PR, or stable disease (SD), as assessed per RECIST v1.1 in Phase Ia.
Duration of response (DOR) in Phase Ia
Duration of response (DOR), defined for participants with confirmed CR or PR as the time from first documented response to first documented disease progression or death from any cause, whichever occurs first, as assessed per RECIST v1.1 in Phase Ia.
Progression-free survival (PFS) in Phase Ia
Progression-free survival (PFS), defined as the time from first dose to first documented disease progression or death from any cause, whichever occurs first, as assessed per RECIST v1.1 in Phase Ia.
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