Actively Recruiting
A Phase 1 Study of BB102 in Participants With Advanced Solid Tumors
Led by Broadenbio Ltd., Co. · Updated on 2025-11-17
78
Participants Needed
2
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1 Study of BB102 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For dose escalation: adults with histologically, cytologically, or clinically confirmed advanced solid tumors without standard treatment options, with disease progression or intolerance to standard treatment.
- For expansion: adults with histologically or cytologically confirmed FGF19 or FGFR4 positive advanced primary hepatocellular carcinoma or other advanced solid tumors without standard treatment options, with disease progression or intolerance to standard treatment.
- At least one evaluable or measurable lesion per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
- Expected survival of 3 months or more.
- Adequate organ function.
- Female participants of childbearing potential must have a negative pregnancy test before first dose and agree to use effective contraception from consent until 6 months after last dose.
- Willingness and ability to provide informed consent and complete all trial procedures.
You will not qualify if you...
- Use of systemic immunosuppressive or corticosteroid therapy (≥10 mg prednisone or equivalent) within 4 weeks.
- Prior treatment with selective FGFR4 inhibitors or pan-FGFR inhibitors.
- Use of cytotoxic chemotherapy within 4 weeks or Chinese traditional antitumor drugs within 2 weeks.
- Anti-tumor endocrine therapy, radiotherapy, interventional embolization, radiofrequency, proton therapy, radioimmunotherapy, immunotherapy, or other biotherapies within 4 weeks.
- Use of other investigational drugs not marketed within 4 weeks.
- Inability to discontinue prohibited treatments for at least 2 weeks.
- Pregnant or lactating females.
- Clinically significant gastrointestinal disorders affecting drug absorption.
- Dual-source cancer within 5 years.
- Uncontrolled or symptomatic central nervous system metastases.
- Severe neurological or psychiatric disorders.
- Uncontrolled cardiovascular diseases.
- Pulmonary embolism within 6 months.
- Prior allogeneic stem cell, bone marrow, or vital organ transplantation.
- Uncontrollable infectious diseases, immunodeficiency, active hepatitis B or C, syphilis, or AIDS.
- Severe active infections within 2 weeks or recent intravenous antibiotic treatment for infection.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Nanfang Hospital
Guangzhou, Guangdong, China
Actively Recruiting
2
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
Research Team
Q
Qi Wang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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