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Phase Ia/Ib Study of FXB0871 Monotherapy in Locally Advanced/Metastatic Solid Tumors

23. dubna 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

138

Fáze

  • Fáze 1

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Čína
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Čína, 200000
        • Shanghai East Hospital
        • Kontakt:
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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
Biologický: 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.
Ostatní jména:
  • TEV-56278
Experimentální: 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
Biologický: 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.
Ostatní jména:
  • TEV-56278
Experimentální: 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
Biologický: 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.
Ostatní jména:
  • TEV-56278
Experimentální: 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
Biologický: 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.
Ostatní jména:
  • TEV-56278

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Incidence and severity of dose-limiting toxicities (DLTs) in Phase Ia
Časové okno: 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
First 2 cycles after first dose (each cycle = 14 days; approximately 28 days).
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), AEs leading to dose delay/interruption/reduction/treatment discontinuation in Phase Ia
Časové okno: 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.
From first dose through 90 days after last dose or initiation of new anti-tumor therapy, whichever occurs first
Objective response rate (ORR) in Phase Ib
Časové okno: 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.
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).

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Objective response rate (ORR) in Phase Ia
Časové okno: 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).
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.
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).
Disease control rate (DCR) in Phase Ia
Časové okno: 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).
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.
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).
Duration of response (DOR) in Phase Ia
Časové okno: From first documented CR or PR until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
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.
From first documented CR or PR until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
Progression-free survival (PFS) in Phase Ia
Časové okno: From first dose until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
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.
From first dose until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
Peak serum concentration (Cmax)
Časové okno: Predose up to Day 8
Maximum observed concentration
Predose up to Day 8
Time to maximum observed concentration (Tmax)
Časové okno: Predose up to Day 8
Time to maximum observed drug concentration
Predose up to Day 8
Area under the serum concentration-time curve (AUC0-last)
Časové okno: Predose up to Day 8
Area under the serum concentration-time curve from time 0 to last measurable drug concentration
Predose up to Day 8
Area under the serum concentration-time curve (AUC0-∞)
Časové okno: Predose up to Day 8
Area under the concentration-time curve from time zero (pre-dose) extrapolation to infinite time
Predose up to Day 8
Area under the serum concentration-time curve (AUCtau)
Časové okno: Predose up to Day 8
Area under the concentration-time curve over the dosing interval
Predose up to Day 8
Trough concentration (Ctrough)
Časové okno: up to Day 8
Observed concentration at the end of a dosing interval, immediately before next administration
up to Day 8
Clearance (CL)
Časové okno: Predose up to Day 8
Systemic (total body) clearance following iv administration
Predose up to Day 8
Volume of distribution (Vz)
Časové okno: Predose up to Day 8
Volume of distribution following iv administration
Predose up to Day 8
Half-life (t1/2)
Časové okno: Predose up to Day 8
Terminal phase half-life
Predose up to Day 8
Average concentration (Cavg)
Časové okno: Predose up to Day 8
Average concentration over a dosing interval
Predose up to Day 8
Accumulation ratio (Rac)
Časové okno: Predose up to Day 8
Accumulation ratio
Predose up to Day 8
Incidence and severity of AEs/SAEs and AEs leading to dose modification or discontinuation in Phase Ib
Časové okno: From first dose through 90 days after last dose or initiation of new anti-tumor therapy, whichever occurs first.
Safety and tolerability in the dose-expansion phase.
From first dose through 90 days after last dose or initiation of new anti-tumor therapy, whichever occurs first.
ORR by modified RECIST (mRECIST) in the HCC cohort of Phase Ib
Časové okno: 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 in participants with hepatocellular carcinoma assessed by mRECIST.
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).
Disease control rate (DCR) in Phase Ib
Časové okno: 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).
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.
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).
Time to response (TTR) in Phase Ib
Časové okno: From first dose to first documented CR or PR (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
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.
From first dose to first documented CR or PR (tumor assessments every 8 ± 1 weeks; approximately up to 24 months).
Duration of response (DOR) in Phase Ib
Časové okno: From first documented CR or PR until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
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.
From first documented CR or PR until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
Title:Progression-free survival (PFS) in Phase Ib
Časové okno: From first dose until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
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.
From first dose until first documented disease progression or death from any cause, whichever occurs first (approximately up to 24 months).
Overall survival (OS) in Phase Ib
Časové okno: From first dose until death from any cause (approximately up to 24 months).
Overall survival measured from first dose to death from any cause.
From first dose until death from any cause (approximately up to 24 months).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

15. května 2026

Primární dokončení (Odhadovaný)

23. dubna 2030

Dokončení studie (Odhadovaný)

18. listopadu 2030

Termíny zápisu do studia

První předloženo

7. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

23. dubna 2026

První zveřejněno (Aktuální)

30. dubna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

30. dubna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

23. dubna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • FXB0871-I101

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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