Phase Ia/Ib Study of FXB0871 Monotherapy in Locally Advanced/Metastatic Solid Tumors
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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
138
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Caicun Zhou
- 電話番号：+86 13301825532
- メール：caicunzhoudr@163.com
研究連絡先のバックアップ
- 名前：Fei Zhou
- 電話番号：+86 13801751704
- メール：story185@126.com
研究場所
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200000
- Shanghai East Hospital
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コンタクト：
- Caicun Zhou
- 電話番号：+86 13301825532
- メール：caicunzhoudr@163.com
-
コンタクト：
- Fei Zhou
- 電話番号：+86 13801751704
- メール：story185@126.com
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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実験的：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.
他の名前：
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実験的：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.
他の名前：
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実験的：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Incidence and severity of dose-limiting toxicities (DLTs) in Phase Ia
時間枠：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
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Objective response rate (ORR) in Phase Ia
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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-∞)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月15日
一次修了 (推定)
2030年4月23日
研究の完了 (推定)
2030年11月18日
試験登録日
最初に提出
2026年4月7日
QC基準を満たした最初の提出物
2026年4月23日
最初の投稿 (実際)
2026年4月30日
学習記録の更新
投稿された最後の更新 (実際)
2026年4月30日
QC基準を満たした最後の更新が送信されました
2026年4月23日
最終確認日
2026年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。