Evaluating BB102 for 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

This study is testing a new drug called BB102 to see if it is safe and effective for people with advanced solid tumors, especially those with specific liver cancers.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years to 78 Years
• Sex: All
• Sponsor: Broadenbio Ltd., Co. (Industry-sponsored)
• Drugs / interventions: immunotherapy, prednisone
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT06258408 on ClinicalTrials.gov

What this trial studies

This Phase 1 study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BB102, a selective FGFR4 inhibitor, in patients with advanced solid tumors. The study consists of a dose escalation phase to determine the maximum tolerated dose and a subsequent expansion phase focusing on patients with FGF19 or FGFR4 positive advanced primary hepatocellular carcinoma or other solid tumors. Participants will receive BB102 as a monotherapy, and various assessments will be conducted to evaluate its effects and safety profile.

Who should consider this trial

Good fit: Ideal candidates include patients with advanced solid tumors who have disease progression on standard treatments or cannot tolerate them, particularly those with FGF19 or FGFR4 positive tumors.

Not a fit: Patients with early-stage tumors or those who have not progressed on standard treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: While this is a first-in-human study, similar approaches targeting FGFR4 have shown promise in other studies, indicating potential for success.

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.

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• Nanfang Hospital — Guangzhou, Guangdong, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Principal investigator: Suxia Luo, MD — Henan Cancer Hospital
• Study coordinator: Qi Wang, PhD

Conditions Advanced Solid Tumor; BB102; FGFR4; First-in-Human; Dose Escalation; FGF19