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

Starting soon · Phase 1

Conditions studied: Solid Tumors, Non-Small Cell Lung Cancer, Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID

NCT07558200

Run by

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

People needed

138

Starts

2026-05-15

Expected to finish

2030-11-18

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Shanghai East Hospital — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

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