Advanced Solid TumorPhase 1NCT06258408
A Phase 1 Study of BB102 in Participants With Advanced Solid Tumors
A Phase 1 study testing BB102 tablet in people with Advanced Solid Tumor, run by Broadenbio Ltd., Co. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- BB102 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 2 sitesChina
- Study dates
- 29 Dec 2022to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong
Yabing Guo, MD, gyabing@126.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Suxia Luo, MD, luosmrm@163.com
About this study
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
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.
Read the 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.
- Conditions
- Advanced Solid Tumor
- Being tested
- BB102 tablet
- Keywords
- BB102, FGFR4, First-in-Human, Dose Escalation, FGF19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BB102 tabletDrug
Also called BB102
BB102 tablets will be administered orally once daily(QD).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: BB102 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Blood samples will be collected for PK analyses
Measured: 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)
Blood samples will be collected for PK analyses
Measured: 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)
Blood samples will be collected for PK analyses
Measured: Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)
Pharmacokinetic Assessments: Elimination half-life (t½)
Blood samples will be collected for PK analyses
Measured: Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)
Objective response rate (ORR)
Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
Measured: 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
Duration of response (DOR)
Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
Measured: 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
Disease control rate (DCR)
Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
Measured: 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
Progression-free survival (PFS)
Tumor response measured by radiologic imaging techniques at baseline and throughout the study.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start29 Dec 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Broadenbio Ltd., Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suxia Luo, MD, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258408
- Sponsor's protocol ID
- BB102-ST-Ⅰ-02
- Status last verified
- Nov 2025
- First submitted
- 6 Feb 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06258408
- Acronym / sponsor ID
- BB102-ST-Ⅰ-02
- Conditions
- Advanced Solid Tumor
- Keywords
- BB102, FGFR4, First-in-Human, Dose Escalation, FGF19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Broadenbio Ltd., Co.Industry (pharma, biotech, devices)
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BB102 monotherapy | Experimental | Drug: BB102 tabletThe 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). |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BB102 tabletAlso: BB102BB102 tablets will be administered orally once daily(QD). | Drug | BB102 monotherapy |
Primary outcome
Number of subjects with dose limiting toxicities (DLTs)
Time frame: Single dose to the end of Cycle 1 (each cycle is 21 days)
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.
Number of subjects with adverse events (AEs) and serious adverse events (SAEs)
Time frame: From screening (Day -28 to Day -1) through up to 12 months or until disease progression
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.
8 secondary outcomes
Pharmacokinetic Assessments: Peak Plasma Concentration (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)
Pharmacokinetic Assessments: Elimination half-life (t½)
Time frame: Day 1, Day 8, Day 15 and at the end of Cycle 1 (each cycle is 21 days)
Objective response rate (ORR)
Time frame: 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
Duration of response (DOR)
Time frame: 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
Disease control rate (DCR)
Time frame: 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
Progression-free survival (PFS)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suxia Luo, MD principal investigator
Henan Cancer Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BB102 tablet in people with Advanced Solid Tumor, run by Broadenbio Ltd., Co. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qi Wang, PhD (+86-15311443674, qi.wang@broadenbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with dose limiting toxicities (DLTs) (time frame: Single dose to the end of Cycle 1 (each cycle is 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.