NCT06143007

A Phase 1 Study of BB3008 in Participants With Advanced Solid Tumors

A Phase I, Open-label, Multicenter Study to Assess Safety, Tolerability, Pharmacokinetic, Efficacy and Preliminary Food Effect of BB3008 Tablet Administered Orally to Patients With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Broadenbio Ltd., Co. · Industry
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 dose escalation study to evaluate the safety, tolerability, pharmacokinetics, efficacy and preliminary food effect of BB3008 as monotherapy in subjects with advanced solid tumors.

Detailed description

This first-in-human (FIH) study of BB3008 will evaluate safety, tolerability, pharmacokinetics (PK) efficacy and preliminary food effect of BB3008 in subjects with advanced solid tumors. The primary objective is to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of BB3008 as monotherapy, and to evaluate the safety and tolerability of BB3008. The secondary objectives include the assessments of PK profile, preliminary efficacy, preliminary food effect (FE) and preliminary metabolites identification of BB3008. The exploratory objectives are to explore biomarkers and C-QTcF analysis.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	BB3008 tablet	BB3008 tablets will be administered orally once daily (QD).

Timeline

• Start date: 2023-10-26
• Primary completion: 2025-05-22
• Completion: 2026-04-01
• First posted: 2023-11-22
• Last updated: 2025-11-17

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study