NCT06258408

A Phase 1 Study of BB102 in Participants With Advanced Solid Tumors

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Profiles and Efficacy of Oral BB102 Tablets in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (estimated)
• Sponsor: Broadenbio Ltd., Co. · Industry
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, efficacy and preliminary food effect of BB102, a highly selective and potent FGFR4 inhibitor, as monotherapy in subjects with advanced solid tumors. This study has two phase: dose escalation phase and expansion phase.

Detailed description

This first-in-human (FIH) study of BB102 will evaluate safety, tolerability, pharmacokinetics (PK), efficacy and preliminary food effect in subjects with advanced solid tumors. In dose escalation trial, the primary objective is to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of BB102 as monotherapy, and to evaluate the safety and tolerability of BB102. The secondary objectives include the assessments of PK profile, preliminary efficacy, preliminary food effect (FE), preliminary metabolites identification, biomarkers and C-QTcF analysis of BB102. In expansion trial, the primary objective is to evaluate the efficacy of BB102 in subjects with FGF19 or FGFR4 positive advanced primary hepatocellular carcinoma (HCC) or other advanced solid tumors. The secondary objectives include the assessments of PK profile, safety and biomarkers of BB102.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	BB102 tablet	BB102 tablets will be administered orally once daily(QD).

Timeline

• Start date: 2022-12-29
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-02-14
• Last updated: 2025-11-17

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study