Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06258408
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-02-06
Brief Title:
A Phase 1 Study of BB102 in Participants With Advanced Solid Tumors
Sponsor:
BrodenBio Co Ltd
Organization:
BrodenBio Co Ltd
Study Overview
Official Title:
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
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None