A Phase 1 Study of BB102 in Participants With Advanced Solid Tumors

NCT06258408 | Recruiting Phase 1 FDA Drug

• 1 other identifier: BB102-ST-Ⅰ-02
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Solid Tumor

Keywords

BB102; FGFR4; First-in-Human; Dose Escalation; FGF19

Outcome Measures

Primary Outcomes (2)

• Number of subjects with dose limiting toxicities (DLTs)

  To assess the safety and tolerability of BB102 tablet as monotherapy in subjects with advanced solid tumors and to determine the maximum tolerated dose (MTD) of BB102 tablet, and to provide a basis for determination of the recommended dose (RP2D) for Phase II clinical trials.

  Single dose to the end of Cycle 1 (each cycle is 21 days)

• Number of subjects with adverse events (AEs) and serious adverse events (SAEs)

  AEs and SAEs will be characterized by type, seriousness, relationship to study treatment, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 5.0) and timing. FGF19 or FGFR4 positive advanced primary HCC or other advanced solid tumors.

  From screening (Day -28 to Day -1) through up to 12 months or until disease progression

Secondary Outcomes (8)

• Pharmacokinetic Assessments: Peak Plasma Concentration (Cmax)

  Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)

• Pharmacokinetic Assessments: Time to Peak Concentration (Tmax)

  Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)

• Pharmacokinetic Assessments: Area under the plasma concentration-time curve (AUC)

  Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)

• Pharmacokinetic Assessments: Elimination half-life (t½)

  Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)

• Objective response rate (ORR)

  From date of screening until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Study Arms (1)

BB102 monotherapy

EXPERIMENTAL

The study is composed of fasted dose cohorts and fed dose cohort. BB102 will be administered orally daily alone as monotherapy in all cohorts. In the fasted dose cohorts, the subjects will receive once daily of BB102 monotherapy fasted across approximately 6 ascending dose levels. The starting dose is 50mg/day. In the fed dose cohort, the subjects will receive once daily of BB102 monotherapy in a fed condition. The dose selected for fed dose cohort must be deemed safe as assessed by safety monitoring committee (SMC).

Drug: BB102 tablet

Interventions

BB102 tablet DRUG

BB102 tablets will be administered orally once daily(QD).

Also known as: BB102

BB102 monotherapy

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Eastern Cooperative Oncology Group (ECOG) score ≤1.
• Expected survival ≥ 3 months.
• Adequate organ function.
• 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.
• 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.

You may not qualify if:

• Use of systemic immunosuppressive or systemic cortisol (≥10 mg prednisone or other equivalent hormones) within 4 weeks.
• Prior use of selective FGFR4 inhibitor and/or pan-FGFR inhibitor therapy.
• 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.
• Anti-tumor endocrine therapy, radiotherapy, interventional embolization, radiofrequency, proton therapy, radioimmunotherapy, immunotherapy or other biotherapies within 4 weeks.
• Use of other clinical investigational drug or therapy that was not marketed within 4 weeks.
• The patient is receiving drugs or therapies prohibited in the protocol and cannot discontinue such use at least 2 weeks.
• Pregnant or lactating females.
• Presence of clinically significant gastrointestinal disorder that may affect the intake, transport, or absorption of the study drug at screening.
• Patient with dual-source cancer within 5 years.
• 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.
• History of severe neurological or psychiatric disorders, including epilepsy, dementia, moderate to severe depression, etc.
• Clinically significant and uncontrolled cardiovascular diseases.
• Pulmonary embolism within 6 months.
• Prior allogeneic stem cell transplantation, bone marrow transplantation or vital organ transplantation.
• Presence of uncontrollable infectious disease, congenital immunodeficiency disease,acquired immunodeficiency syndrome, syphilis, active hepatitis B, hepatitis C virus (HCV) infection.

Sponsors & Collaborators

• Broadenbio Ltd., Co.: lead

Study Sites (2)

Nanfang Hospital

Guangzhou, Guangdong, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, China

RECRUITING

Study Officials

• Suxia Luo, MD

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qi Wang, PhD

CONTACT

+86-15311443674; qi.wang@broadenbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 14, 2024
• Study Start: December 29, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (2)