Phase Ia/Ib Study of FXB0871 Monotherapy in Locally Advanced/Metastatic Solid Tumors
23 de abril de 2026 actualizado por: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
A Phase 1a/1b Open-Label, Multicenter, Dose Escalation, and Dose Expansion Trial to Evaluate the Safety, Anti-tumor Activity, Pharmacokinetic/Pharmacodynamic Characteristics of FXB0871 as Monotherapy in Participants With Selected Locally Advanced or Metastatic Solid Tumors
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.
Descripción general del estudio
Estado
Aún no reclutando
Descripción detallada
This first-in-human study consists of a dose-escalation part (Part Ia) and a dose-expansion part (Part Ib). In Part Ia, adults with selected locally advanced or metastatic solid tumors will receive FXB0871 monotherapy by intravenous infusion every 2 weeks in sequential pre-determinde dose cohorts using a Bayesian optimal interval design. The planned dosing schedule is every 2 weeks, with a dose-limiting toxicity observation period of the first 2 treatment cycles. Additional intermediate dose levels, cohort expansion, and schedule optimization to every 3 or 4 weeks may be allowed according to protocol-defined safety, PK/PD, and preliminary antitumor activity data.
Part Ib will start after determination of the monotherapy recommended phase 2 dose (RP2D). Cohort A will enroll participants with PD-(L)1-resistant locally advanced or metastatic non-small cell lung cancer and randomize them 1:1 to receive FXB0871 at the RP2D or at a lower dose selected on the basis of Part Ia data. Cohort B will enroll participants with PD-(L)1-resistant locally advanced or metastatic hepatocellular carcinoma to receive FXB0871 at the RP2D. Participants may continue study treatment for up to 12 months or until unacceptable toxicity, disease progression, or another protocol-defined discontinuation criterion is met.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
138
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Caicun Zhou
- Número de teléfono: +86 13301825532
- Correo electrónico: caicunzhoudr@163.com
Copia de seguridad de contactos de estudio
- Nombre: Fei Zhou
- Número de teléfono: +86 13801751704
- Correo electrónico: story185@126.com
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200000
- Shanghai East Hospital
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Contacto:
- Caicun Zhou
- Número de teléfono: +86 13301825532
- Correo electrónico: caicunzhoudr@163.com
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Contacto:
- Fei Zhou
- Número de teléfono: +86 13801751704
- Correo electrónico: story185@126.com
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Arm1：Part Ia Dose Escalation
Participants with selected locally advanced or metastatic solid tumors will receive FXB0871 monotherapy by intravenous infusion every 2 weeks in sequential pre-determined dose-escalation cohorts or at intermediate dose levels every 2 weeks
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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.
Otros nombres:
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Experimental: Arm2：Part Ib Dose Expansion (NSCLC, RP2D)
Participants with locally advanced or metastatic IO-resistant NSCLC will be randomized 1:1 to receive FXB0871 monotherapy at RP2D from Phase Ia by intravenous infusion every 2 weeks
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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.
Otros nombres:
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Experimental: Arm3：Part Ib Dose Expansion(NSCLC, <RP2D)
Participants with locally advanced or metastatic IO-resistant NSCLC will be randomized 1:1 to receive FXB0871 monotherapy at a selected lower dose than RP2D from Phase Ia by intravenous infusion every 2 weeks
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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.
Otros nombres:
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Experimental: Arm4：Part Ib Dose Expansion(HCC, RP2D)
Participants with locally advanced or metastatic IO-resistant HCC will receive FXB0871 monotherapy at RP2D from Phase Ia by intravenous infusion every 2 weeks
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence and severity of dose-limiting toxicities (DLTs) in Phase Ia
Periodo de tiempo: First 2 cycles after first dose (each cycle = 14 days; approximately 28 days).
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Percentage of participants with protocol-defined DLTs during the DLT observation period in the dose-escalation phase
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First 2 cycles after first dose (each cycle = 14 days; approximately 28 days).
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Incidence and severity of adverse events (AEs), serious adverse events (SAEs), AEs leading to dose delay/interruption/reduction/treatment discontinuation in Phase Ia
Periodo de tiempo: From first dose through 90 days after last dose or initiation of new anti-tumor therapy, whichever occurs first
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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.
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From first dose through 90 days after last dose or initiation of new anti-tumor therapy, whichever occurs first
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Objective response rate (ORR) in Phase Ib
Periodo de tiempo: 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).
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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.
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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).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Objective response rate (ORR) in Phase Ia
Periodo de tiempo: From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study, whichever occurs first (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
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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.
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From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study, whichever occurs first (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
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Disease control rate (DCR) in Phase Ia
Periodo de tiempo: From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study, whichever occurs first (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
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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.
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From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study, whichever occurs first (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
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Duration of response (DOR) in Phase Ia
Periodo de tiempo: From first documented CR or PR until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
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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.
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From first documented CR or PR until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
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Progression-free survival (PFS) in Phase Ia
Periodo de tiempo: From first dose until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
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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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From first dose until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
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Peak serum concentration (Cmax)
Periodo de tiempo: Predose up to Day 8
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Maximum observed concentration
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Predose up to Day 8
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Time to maximum observed concentration (Tmax)
Periodo de tiempo: Predose up to Day 8
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Time to maximum observed drug concentration
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Predose up to Day 8
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Area under the serum concentration-time curve (AUC0-last)
Periodo de tiempo: Predose up to Day 8
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Area under the serum concentration-time curve from time 0 to last measurable drug concentration
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Predose up to Day 8
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Area under the serum concentration-time curve (AUC0-∞)
Periodo de tiempo: Predose up to Day 8
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Area under the concentration-time curve from time zero (pre-dose) extrapolation to infinite time
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Predose up to Day 8
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Area under the serum concentration-time curve (AUCtau)
Periodo de tiempo: Predose up to Day 8
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Area under the concentration-time curve over the dosing interval
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Predose up to Day 8
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Trough concentration (Ctrough)
Periodo de tiempo: up to Day 8
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Observed concentration at the end of a dosing interval, immediately before next administration
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up to Day 8
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Clearance (CL)
Periodo de tiempo: Predose up to Day 8
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Systemic (total body) clearance following iv administration
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Predose up to Day 8
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Volume of distribution (Vz)
Periodo de tiempo: Predose up to Day 8
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Volume of distribution following iv administration
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Predose up to Day 8
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Half-life (t1/2)
Periodo de tiempo: Predose up to Day 8
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Terminal phase half-life
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Predose up to Day 8
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Average concentration (Cavg)
Periodo de tiempo: Predose up to Day 8
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Average concentration over a dosing interval
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Predose up to Day 8
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Accumulation ratio (Rac)
Periodo de tiempo: Predose up to Day 8
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Accumulation ratio
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Predose up to Day 8
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Incidence and severity of AEs/SAEs and AEs leading to dose modification or discontinuation in Phase Ib
Periodo de tiempo: From first dose through 90 days after last dose or initiation of new anti-tumor therapy, whichever occurs first.
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Safety and tolerability in the dose-expansion phase.
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From first dose through 90 days after last dose or initiation of new anti-tumor therapy, whichever occurs first.
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ORR by modified RECIST (mRECIST) in the HCC cohort of Phase Ib
Periodo de tiempo: 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).
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ORR in participants with hepatocellular carcinoma assessed by mRECIST.
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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).
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Disease control rate (DCR) in Phase Ib
Periodo de tiempo: From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study, whichever occurs first (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
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Disease control rate (DCR), defined as the proportion of participants with a best overall response of CR, PR, or SD, as assessed per RECIST v1.1 in Phase Ib.
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From first dose until disease progression, start of new anti-tumor therapy, withdrawal, death, or end of study, whichever occurs first (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
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Time to response (TTR) in Phase Ib
Periodo de tiempo: From first dose to first documented CR or PR (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
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Time to response (TTR), defined as the time from first dose to the first documented CR or PR, as assessed per RECIST v1.1 in Phase Ib.
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From first dose to first documented CR or PR (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
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Duration of response (DOR) in Phase Ib
Periodo de tiempo: From first documented CR or PR until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
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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 Ib.
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From first documented CR or PR until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
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Title:Progression-free survival (PFS) in Phase Ib
Periodo de tiempo: From first dose until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
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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 Ib.
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From first dose until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
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Overall survival (OS) in Phase Ib
Periodo de tiempo: From first dose until death from any cause (approximately up to 24 months).
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Overall survival measured from first dose to death from any cause.
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From first dose until death from any cause (approximately up to 24 months).
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de mayo de 2026
Finalización primaria (Estimado)
23 de abril de 2030
Finalización del estudio (Estimado)
18 de noviembre de 2030
Fechas de registro del estudio
Enviado por primera vez
7 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
23 de abril de 2026
Publicado por primera vez (Actual)
30 de abril de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de abril de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
23 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por sitio
- Neoplasias
- Enfermedades de las vías respiratorias
- Neoplasias por tipo histológico
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades pulmonares
- Enfermedades del HIGADO
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Neoplasias Hepaticas
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Neoplasias Pulmonares
- Carcinoma
- Carcinoma Broncogénico
- Neoplasias Bronquiales
- Carcinoma Hepatocelular
- Carcinoma de pulmón de células no pequeñas
Otros números de identificación del estudio
- FXB0871-I101
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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