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FXB0871 for advanced solid tumors, including lung and liver cancer

Tests FXB0871 for safety and effect in adults with advanced solid tumors.

Key facts

Who runs it
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Where
Shanghai, ChinaSee the site
Trial code
Registry title
Phase Ia/Ib Study of FXB0871 Monotherapy in Locally Advanced/Metastatic Solid Tumors
Status
Not yet recruiting
Phase
Phase 1
People taking part
138 people, planned
Started
15 May 2026
Expected to end
18 Nov 2030
Type of study
Interventional, 4 groups
Treatments tested
  • Intervention1：FXB0871
  • Intervention2：FXB0871
  • Intervention3：FXB0871
  • Intervention4：FXB0871
Record updated
30 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with certain advanced or spread solid tumors that got worse after standard treatment, cannot be treated with it, or have no standard treatment. Some groups need lung or liver cancer that stopped responding to PD-(L)1 treatment.

Age
18 years or older.
Sex
All sexes can join.
Disease stage
Locally advanced or metastatic solid tumor confirmed by tissue exam. In the expansion part: non-small cell lung cancer or hepatocellular carcinoma resistant to PD-(L)1 treatment. At least one measurable tumor lesion (RECIST v1.1).
Earlier treatment
The tumor must have progressed on standard therapy, or standard therapy was not tolerated or not available. Prior anti-PD-(L)1 treatment failure is needed for the selected groups. No prior IL-2, IL-15 or IL-7 treatment.
Biomarker or test result
Tumor tissue must be available (archival or fresh biopsy). Left ventricular ejection fraction above 50% and oxygen saturation of at least 92% on room air.

Main reasons for not taking part

  • Cancer treatment, major surgery or radical radiotherapy within 4 weeks before the first dose
  • Active autoimmune disease needing systemic treatment, or immunodeficiency
  • Active or untreated brain or central nervous system metastases
  • Active hepatitis B/C, syphilis or HIV infection
  • Pregnancy or breastfeeding

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Systemic corticosteroids (≥10 mg/day prednisone equivalent) or other immunosuppressive therapy within 28 days before first dose, with limited protocol-defined exceptions
  • Uncontrolled infection or clinically significant unresolved toxicities from prior therapy
  • Active autoimmune disease requiring systemic treatment or immunodeficiency
  • Active or untreated central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease
  • 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
  • Any other serious medical or psychiatric condition that, in the investigator's judgment, would make participation inappropriate
  • Pregnancy or breastfeeding

Where in China

  • Shanghai East HospitalShanghai, ChinaContact: Caicun ZhouNo longer taking part

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • Arm1：Part Ia Dose EscalationTreatment being tested

    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

    Treatment: Intervention1：FXB0871

  • Arm2：Part Ib Dose Expansion (NSCLC, RP2D)Treatment being tested

    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

    Treatment: Intervention2：FXB0871

  • Arm3：Part Ib Dose Expansion(NSCLC, <RP2D)Treatment being tested

    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

    Treatment: Intervention3：FXB0871

  • Arm4：Part Ib Dose Expansion(HCC, RP2D)Treatment being tested

    Participants with locally advanced or metastatic IO-resistant HCC will receive FXB0871 monotherapy at RP2D from Phase Ia by intravenous infusion every 2 weeks

    Treatment: Intervention4：FXB0871

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
FXB0871 for advanced solid tumors, including lung and liver cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
30 April 2026