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

NCT07558200 | Not Yet Recruiting Phase 1

• 1 other identifier: FXB0871-I101
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma; Solid Tumors; Non-Small Cell Lung Cancer

Keywords

FXB0871; TEV-56278; PD-1; IL-2; Dose Escalation; Dose Expansion

Outcome Measures

Primary Outcomes (3)

• Incidence and severity of dose-limiting toxicities (DLTs) in Phase Ia

  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

  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

  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).

Secondary Outcomes (22)

• Objective response rate (ORR) 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

  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

  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

  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)

  Predose up to Day 8

Study Arms (4)

Arm1：Part Ia Dose Escalation

EXPERIMENTAL

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

Biological: Intervention1：FXB0871

Arm2：Part Ib Dose Expansion (NSCLC, RP2D)

EXPERIMENTAL

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

Biological: Intervention2：FXB0871

Arm3：Part Ib Dose Expansion(NSCLC, <RP2D)

EXPERIMENTAL

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

Biological: Intervention3：FXB0871

Arm4：Part Ib Dose Expansion(HCC, RP2D)

EXPERIMENTAL

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

Biological: Intervention4：FXB0871

Interventions

Intervention1：FXB0871 BIOLOGICAL

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.

Also known as: TEV-56278

Arm1：Part Ia Dose Escalation

Intervention2：FXB0871 BIOLOGICAL

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.

Also known as: TEV-56278

Arm2：Part Ib Dose Expansion (NSCLC, RP2D)

Intervention3：FXB0871 BIOLOGICAL

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.

Also known as: TEV-56278

Arm3：Part Ib Dose Expansion(NSCLC, <RP2D)

Intervention4：FXB0871 BIOLOGICAL

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.

Also known as: TEV-56278

Arm4：Part Ib Dose Expansion(HCC, RP2D)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases

Central Study Contacts

Caicun Zhou

CONTACT

+86 13301825532; caicunzhoudr@163.com

Fei Zhou

CONTACT

+86 13801751704; story185@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 30, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): April 23, 2030
• Study Completion (Estimated): November 18, 2030
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

CN (1)