NCT06258408 A Phase 1 Study of BB102 in Participants With Advanced Solid Tumors
| NCT ID | NCT06258408 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Broadenbio Ltd., Co. |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2022-12-29 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 78 participants in total. It began in 2022-12-29 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. For the dose escalation trial, histologically, cytologically confirmed or clinically confirmed advanced solid tumors patients who without available standard treatment, have disease progression on standard treatment or cannot tolerate standard treatment. For the expansion trial, histologically or cytologically confirmed FGF19 or FGFR4 positive advanced primary HCC or other advanced solid tumors patients who without available standard treatment, have disease progression on standard treatment or cannot tolerate standard treatment. 2. For the dose escalation trial, at least one evaluable lesion as defined by RECIST v1.1. For the expansion trial, at least one measurable lesion as defined by RECIST v1.1. 3. Eastern Cooperative Oncology Group (ECOG) score ≤1. 4. Expected survival ≥ 3 months. 5. Adequate organ function. 6. Female subjects of childbearing potential must have a negative pregnancy test prior to the first dose and are required to use effective contraception from signing the ICF until 6 months after the last dose of study treatment. 7. Fully informed of the study and voluntarily signed the informed consent form (ICF), and willing to follow and have the ability to complete all trial procedures. Exclusion Criteria: 1. Use of systemic immunosuppressive or systemic cortisol (≥10 mg prednisone or other equivalent hormones) within 4 weeks. 2. Prior use of selective FGFR4 inhibitor and/or pan-FGFR inhibitor therapy. 3. Use of cytotoxic chemotherapeutics within 4 weeks, OR use of state-approved Chinese traditional patent drugs/Chinese traditional drugs with an antitumor effect within 2 weeks. 4. Anti-tumor endocrine therapy, radiotherapy, interventional embolization, radiofrequency, proton therapy, radioimmunotherapy, immunotherapy or other biotherapies within 4 weeks. 5. Use of other clinical investigational drug or therapy that was not marketed within 4 weeks. 6. The patient is receiving drugs or therapies prohibited in the protocol and cannot discontinue such use at least 2 weeks. 7. Pregnant or lactating females. 8. Presence of clinically significant gastrointestinal disorder that may affect the intake, transport, or absorption of the study drug at screening. 9. Patient with dual-source cancer within 5 years. 10. Presence of clinically symptomatic metastases to the central nervous system or meninges or other evidence showing that metastatic lesions in the central nervous system or meninges have not yet been controlled at screening, which, at the investigator's discretion, is not suitable for enrollment. 11. History of severe neurological or psychiatric disorders, including epilepsy, dementia, moderate to severe depression, etc. 12. Clinically significant and uncontrolled cardiovascular diseases. 13. Pulmonary embolism within 6 months. 14. Prior allogeneic stem cell transplantation, bone marrow transplantation or vital organ transplantation. 15. Presence of uncontrollable infectious disease, congenital immunodeficiency disease,acquired immunodeficiency syndrome, syphilis, active hepatitis B, hepatitis C virus (HCV) infection. 16. Severe active infection, including but not limited to bacteremia, severe pneumonia, etc., occurred within 2 weeks; an active infection that received therapeutic intravenous antibiotics within 2 weeks.
Contact & Investigator
Suxia Luo, MD
PRINCIPAL INVESTIGATOR
Henan Cancer Hospital
Frequently Asked Questions
Who can join the NCT06258408 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 78 Years, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06258408 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06258408 currently recruiting?
Yes, NCT06258408 is actively recruiting participants. Contact the research team at qi.wang@broadenbio.com for enrollment information.
Where is the NCT06258408 trial being conducted?
This trial is being conducted at Guangzhou, China, Zhengzhou, China.
Who is sponsoring the NCT06258408 clinical trial?
NCT06258408 is sponsored by Broadenbio Ltd., Co.. The principal investigator is Suxia Luo, MD at Henan Cancer Hospital. The trial plans to enroll 78 participants.