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

23 апреля 2026 г. обновлено: 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.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

138

Фаза

  • Фаза 1

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Caicun Zhou
  • Номер телефона: +86 13301825532
  • Электронная почта: caicunzhoudr@163.com

Учебное резервное копирование контактов

  • Имя: Fei Zhou
  • Номер телефона: +86 13801751704
  • Электронная почта: story185@126.com

Места учебы

  • Китай
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Китай, 200000
        • Shanghai East Hospital
        • Контакт:
          • Caicun Zhou
          • Номер телефона: +86 13301825532
          • Электронная почта: caicunzhoudr@163.com
        • Контакт:
          • Fei Zhou
          • Номер телефона: +86 13801751704
          • Электронная почта: story185@126.com

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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
Биологический: 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.
Другие имена:
  • TEV-56278
Экспериментальный: 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
Биологический: 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.
Другие имена:
  • TEV-56278
Экспериментальный: 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
Биологический: 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.
Другие имена:
  • TEV-56278
Экспериментальный: 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
Биологический: 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.
Другие имена:
  • TEV-56278

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Incidence and severity of dose-limiting toxicities (DLTs) in Phase Ia
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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).

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Objective response rate (ORR) in Phase Ia
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: Predose up to Day 8
Maximum observed concentration
Predose up to Day 8
Time to maximum observed concentration (Tmax)
Временное ограничение: 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)
Временное ограничение: 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-∞)
Временное ограничение: 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)
Временное ограничение: Predose up to Day 8
Area under the concentration-time curve over the dosing interval
Predose up to Day 8
Trough concentration (Ctrough)
Временное ограничение: up to Day 8
Observed concentration at the end of a dosing interval, immediately before next administration
up to Day 8
Clearance (CL)
Временное ограничение: Predose up to Day 8
Systemic (total body) clearance following iv administration
Predose up to Day 8
Volume of distribution (Vz)
Временное ограничение: Predose up to Day 8
Volume of distribution following iv administration
Predose up to Day 8
Half-life (t1/2)
Временное ограничение: Predose up to Day 8
Terminal phase half-life
Predose up to Day 8
Average concentration (Cavg)
Временное ограничение: Predose up to Day 8
Average concentration over a dosing interval
Predose up to Day 8
Accumulation ratio (Rac)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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).

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

15 мая 2026 г.

Первичное завершение (Оцененный)

23 апреля 2030 г.

Завершение исследования (Оцененный)

18 ноября 2030 г.

Даты регистрации исследования

Первый отправленный

7 апреля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

23 апреля 2026 г.

Первый опубликованный (Действительный)

30 апреля 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

30 апреля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

23 апреля 2026 г.

Последняя проверка

1 апреля 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • FXB0871-I101

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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