Intervention1：FXB0871: FXB0871 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: FXB0871 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: FXB0871 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: FXB0871 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
* At least one measurable lesion per RECIST v1.1.
* Pretreatment tumor tissue available (archival or fresh biopsy).
* Life expectancy ≥12 weeks.
* Oxygen saturation ≥92% on room air.
* Left ventricular ejection fraction \>50%.
* Adequate hematologic, coagulation, renal, hepatic, and cardiac function.
* Women of childbearing potential and sexually active men must use highly effective contraception.
* Tumor-specific eligibility applies, including prior anti-PD-(L)1 treatment failure for the selected cohorts.
Key Exclusion Criteria:
* 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.
* Active or untreated central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease.
* Uncontrolled infection or clinically significant unresolved toxicities from prior therapy.
* Clinically significant cardiovascular/cerebrovascular disease, uncontrolled effusions/ascites, uncontrolled hypertension, or QTcF \>470 ms.
* Active hepatitis B/C, syphilis, or HIV infection.
* Clinically significant interstitial lung disease or active noninfectious pneumonitis.
* Pregnancy or breastfeeding.
* Any other serious medical or psychiatric condition that, in the investigator's judgment, would make participation inappropriate.
Primary outcome measure(s)
Incidence and severity of dose-limiting toxicities (DLTs) in Phase Ia — First 2 cycles after first dose (each cycle = 14 days; approximately 28 days). 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 — From first dose through 90 days after last dose or initiation of new anti-tumor therapy, whichever occurs first 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 — From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study (assessed every 8±1 weeks; approximately up to 24 months). 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.
Trial sites (1)
Facility
City
Region
Status
Shanghai East Hospital
Shanghai
Shanghai Municipality
More Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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