Phase Ia/Ib Study of FXB0871 Monotherapy in Locally Advanced/Metastatic Solid Tumors
2026년 4월 23일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
138
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Caicun Zhou
- 전화번호: +86 13301825532
- 이메일: caicunzhoudr@163.com
연구 연락처 백업
- 이름: Fei Zhou
- 전화번호: +86 13801751704
- 이메일: story185@126.com
연구 장소
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200000
- Shanghai East Hospital
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연락하다:
- Caicun Zhou
- 전화번호: +86 13301825532
- 이메일: caicunzhoudr@163.com
-
연락하다:
- Fei Zhou
- 전화번호: +86 13801751704
- 이메일: story185@126.com
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
다른 이름들:
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실험적: 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.
다른 이름들:
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실험적: 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.
다른 이름들:
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실험적: 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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence and severity of dose-limiting toxicities (DLTs) in Phase Ia
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objective response rate (ORR) in Phase Ia
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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-∞)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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.
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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
기간: 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
기간: 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.
|
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
기간: 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.
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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
기간: 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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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 15일
기본 완료 (추정된)
2030년 4월 23일
연구 완료 (추정된)
2030년 11월 18일
연구 등록 날짜
최초 제출
2026년 4월 7일
QC 기준을 충족하는 최초 제출
2026년 4월 23일
처음 게시됨 (실제)
2026년 4월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 4월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 4월 23일
마지막으로 확인됨
2026년 4월 1일
추가 정보
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