Carcinoma, Basal Cell (BCC)Phase 4NCT06880848
Sonidegib in Adult Patients With Locally Advanced Basal Cell Carcinoma (laBCC) in China
A Phase 4 study testing Sonidegib Phosphate Capsules in people with Carcinoma, Basal Cell (BCC), run by Jemincare at 1 site in China.
Trial summary
This is a Phase IV, single arm, multicenter study designed to evaluate the efficacy and safety profile of Sonidegib in chinese participants with locally advanced basal cell carcinoma (laBCC) who are not amenable to radiation therapy, curative surgery or other local therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Basal Cell (BCC)
- What is being tested?
- Sonidegib Phosphate Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2023to 26 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Patients with a histologically confirmed diagnosis of laBCC that is not amenable to radiation therapy, curative surgery, or other local therapies. Patients with laBCC must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥ 10 mm, with MRI/CT scan or on color photographs.
- ECOG PS Score ≤ 2.
- Patients with adequate bone marrow, liver and renal function.
- Written informed consent obtained prior to any screening procedures.
- Patients are willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions.
- Females of childbearing potential agree to use contraception during treatment and for 20 months following the last dose; male patients (even after vasectomy) agree to use contraception during treatment and for 8 months after the last dose.
Who cannot join
- Subjects in the opinion of the investigator are immunosuppressed (e.g., organ transplant recipients, HIV, systemic invasive malignancy within past 5 years excluding Stage I cervical cancer, ductal carcinoma in situ of the breast or CLL stage 0, graft vs. host disease, etc.).
- LaBCC patients with skin lesions in multiple body locations will not be considered metastatic patients. LaBCC patients with positive (histological confirmation of BCC) regional nodal disease will be considered to have metastatic disease.
- Poorly controlled diabetes mellitus (as per Investigator's discretion in consultation with Sponsor's medical monitor).
- Major surgery within 4 weeks prior to study treatment.
- Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study or potentially affect the interpretation of the study data.
- Patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract or known malabsorption syndromes.
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- Patients who have previously been treated with systemic Sonidegib or with other Hh pathway inhibitors.
- Patients who have neuromuscular disorders (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy).
- Patients who are planning on embarking on a new strenuous exercise regimen after initiation of study treatment.
- Have participated in other clinical trials within 4 weeks prior to the first dose of sonidegib.
- Have received other anti-neoplastic therapy within 4 weeks prior to study treatment.
- Patients who are receiving medications known to be moderate and strong inhibitors or inducers of cytochrome P450 (CYP) 3A4/5 or drugs metabolized by CYP2B6 or CYP2C9 that have narrow therapeutic index, and that cannot be discontinued before starting treatment with sonidegib. Medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with sonidegib.
- Pregnant or nursing (lactating) women, confirmed by a positive hCG laboratory test (> 5mIU/mL).
- Unwilling or unable to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open-Label, Single-Arm, Multi-Center, Phase IV Efficacy and Safety Study of Sonidegib in Adult Patients With Locally Advanced Basal Cell Carcinoma (laBCC) in China
This is a Phase IV, single arm, multicenter study designed to evaluate the efficacy and safety profile of Sonidegib in chinese participants with locally advanced basal cell carcinoma (laBCC) who are not amenable to radiation therapy, curative surgery or other local therapies.
- Conditions
- Carcinoma, Basal Cell (BCC)
- Being tested
- Sonidegib Phosphate Capsules
- Keywords
- BCC, Basal Cell Carcinoma
- Medical subject headings
- Carcinoma, Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonidegib Phosphate CapsulesDrug
Sonidegib should be taken 1 hour before or 2 hours after a breakfast
| Study group | Role | What they receive |
|---|---|---|
| Sonidegib Phosphate Capsules | Experimental | Participants will receive continuous treatment with oral administration once a day until conditions for treatment termination are met. Receives: Drug: Sonidegib Phosphate Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the percentage of participants with a confirmed complete or partial response (CR or PR) , per modified Response Evaluation Criteria in Solid Tumors (mRECIST) as assessed by central review.
Measured: up to 1 year
Secondary outcomes (5)
Duration of Response (DoR)
The DOR for a responder is defined as the time from the participant's initial CR or PR to the first date of either disease progression or death, whichever occurs first. CR, PR and PD will be determined per mRECIST by investigator and central review, respectively
Measured: up to 1 year
Complete response rate (CRR) per central and investigator review
CRR is defined as the percentage of participants who achieved a complete response per mRECIST
Measured: up to 1 year
Progression-free Survival (PFS)
PFS is defined as the time from the participant's first dose of study treatment to the first date of either disease progression or death, whichever occurs first. Disease progression will be determined per mRECIST by investigator and central review, respectively
Measured: up to 1 year
Time to tumor response (TTR)
TTR is defined as the time from the participant's first dose of study treatment to the date of initial CR or PR. CR and PR will be determined per mRECIST by investigator and central review, respectively.
Measured: up to 1 year
Adverse event (AE)/Serious adverse event (SAE)/Treatment emergent adverse event (TEAE)
Adverse events, and changes from baseline in vital signs,etc
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start21 Jun 2023
- Primary completion26 Aug 2025
- Study completion26 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Basal Cell (BCC)Studies of the same condition, open and under way.
- More trials run by JemincareThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sun Pharmaceutical Industries Limited, Zhejiang Hangyu Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Hang Li, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880848
- Sponsor's protocol ID
- AM20220301
- Status last verified
- Sep 2025
- First submitted
- 12 Mar 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Single-Arm, Multi-Center, Phase IV Efficacy and Safety Study of Sonidegib in Adult Patients With Locally Advanced Basal Cell Carcinoma (laBCC) in China
- ClinicalTrials.gov ID
- NCT06880848
- Acronym / sponsor ID
- AM20220301
- Conditions
- Carcinoma, Basal Cell (BCC)
- Keywords
- BCC, Basal Cell Carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Collaborators
- Sun Pharmaceutical Industries Limited, Zhejiang Hangyu Pharmaceutical Co., Ltd.
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 26 Aug 2025 (actual)
- First posted
- 18 Mar 2025 (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 IV, single arm, multicenter study designed to evaluate the efficacy and safety profile of Sonidegib in chinese participants with locally advanced basal cell carcinoma (laBCC) who are not amenable to radiation therapy, curative surgery or other local therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sonidegib Phosphate Capsules | Experimental | Drug: Sonidegib Phosphate CapsulesParticipants will receive continuous treatment with oral administration once a day until conditions for treatment termination are met. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older.
- Patients with a histologically confirmed diagnosis of laBCC that is not amenable to radiation therapy, curative surgery, or other local therapies. Patients with laBCC must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥ 10 mm, with MRI/CT scan or on color photographs.
- ECOG PS Score ≤ 2.
- Patients with adequate bone marrow, liver and renal function.
- Written informed consent obtained prior to any screening procedures.
Key exclusion criteria (14 listed)
- Subjects in the opinion of the investigator are immunosuppressed (e.g., organ transplant recipients, HIV, systemic invasive malignancy within past 5 years excluding Stage I cervical cancer, ductal carcinoma in situ of the breast or CLL stage 0, graft vs. host disease, etc.).
- LaBCC patients with skin lesions in multiple body locations will not be considered metastatic patients. LaBCC patients with positive (histological confirmation of BCC) regional nodal disease will be considered to have metastatic disease.
- Poorly controlled diabetes mellitus (as per Investigator's discretion in consultation with Sponsor's medical monitor).
- Major surgery within 4 weeks prior to study treatment.
- Patients with concurrent uncontrolled medical conditions that may interfere with their participation in the study or potentially affect the interpretation of the study data.
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 |
|---|---|---|
| Sonidegib Phosphate CapsulesSonidegib should be taken 1 hour before or 2 hours after a breakfast | Drug | Sonidegib Phosphate Capsules |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 1 year
Objective response rate (ORR) is defined as the percentage of participants with a confirmed complete or partial response (CR or PR) , per modified Response Evaluation Criteria in Solid Tumors (mRECIST) as assessed by central review.
5 secondary outcomes
Duration of Response (DoR)
Time frame: up to 1 year
Complete response rate (CRR) per central and investigator review
Time frame: up to 1 year
Progression-free Survival (PFS)
Time frame: up to 1 year
Time to tumor response (TTR)
Time frame: up to 1 year
Adverse event (AE)/Serious adverse event (SAE)/Treatment emergent adverse event (TEAE)
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Hang Li principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sonidegib Phosphate Capsules in people with Carcinoma, Basal Cell (BCC), run by Jemincare at 1 site 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 7 inclusion and 14 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: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: up to 1 year). 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 24 Sep 2025.