Metastatic Nasopharyngeal CarcinomaPhase 1NCT06886347
Metastatic Nasopharyngeal Carcinoma
A Phase 1 study testing Penplimab Injection, Antitinib Hydrochloride Capsules and Gemcitabine in people with Metastatic Nasopharyngeal Carcinoma, run by Chen Xiaozhong at 1 site in China.
Trial summary
To evaluaate the efficacy and safety of the regimen incuding Penpulimab, Gemcitabine and Anlotinib in the treatment of metastatic nasopharyngeal carcinoma. Using Progression-Free-Survival as the primary endpoint. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Nasopharyngeal Carcinoma
- What is being tested?
- Penplimab Injection, Antitinib Hydrochloride Capsules and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2023to 1 Apr 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participants voluntarily signed an informed consent form.
- Age of ≥ 18 years and ≤ 75 years at the time of enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- xpected survival of ≥ 3 months.
- Histologically or cytologically confirmed diagnosis of stage IVb NPC (AJCC 8th).
- Metastatic NPC patients who have not recieved the first-line platinumbased chemotherapy.
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- At least one measurable tumor lesion per RECIST 1.1 criteria.
- Adequate organ function.
- Female participants of childbearing potential must agree to use contraception (such as intrauterine device, contraceptive pill, or condom) during the study and for 6 months after the end of the study; must have a negative serum pregnancy test within 7 days before study entry and must not be lactating. Male participants must agree to use contraception during the study and for 6 months after the end of the study.
- The subjects are willing and able to comply with the visit schedule, treatment plan, laboratory examination, and other requirements of the study.
Who cannot join
- ubjects have had another malignancy within 3 years before the first dose, except nasopharyngeal carcinoma. Subjects with other malignancies that have been cured by local therapy such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervix or breast carcinoma in situ are not excluded.
- Participation in treatment with an investigational drug or use of an investigational device within 4 weeks before first study dosing.
- Palliative local treatment was performed for non target lesions within 2 weeks before the first administration; Received nonspecific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc., excluding IL-11 for the treatment of thrombocytopenia) within 2 weeks before the first administration; Received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week before the first administration.
- Progression during or within 6 months after receiving systemic treatment for locally advanced disease (including induction therapy, concurrent radiotherapy, adjuvant therapy) (excluding oral single agent chemotherapy maintenance).
- Patients with local recurrence and distant metastasis after radical treatment for locally advanced disease.
- Patients with recurrent nasopharyngeal lesions after radiotherapy and who have received secondary radiotherapy.
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- Have previously received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists , immune cell therapy, and other treatments against tumor immune mechanism.
- Previously received anti angiogenic therapy.
- According to the judgment of the investigator, there are subjects with concomitant diseases that seriously endanger the safety of subjects or affect the completion of the study, or subjects who believe that there are other reasons that are not suitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 325000
Xiaozhong Chen, Doctor, 0571-88128202, chenxz@zjcc.org.cn
About this study
Official title: Penpulimab Plus Gemcitabine and Anlotinib in the Treatment of Metastatic Nasopharyngeal Cancer, A Single Arm, Open-label, Phase Ib Clinical Trial
To evaluaate the efficacy and safety of the regimen incuding Penpulimab, Gemcitabine and Anlotinib in the treatment of metastatic nasopharyngeal carcinoma. Using Progression-Free-Survival as the primary endpoint.
- Conditions
- Metastatic Nasopharyngeal Carcinoma
- Being tested
- Penplimab Injection, Antitinib Hydrochloride Capsules, Gemcitabine
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Penplimab InjectionDrug
Penplimab Injection: Intravenous infusion of Penplimab 200 mg Q3W, with a 3-week treatment cycle.
Anlotinib Hydrochloride Capsules: 10 mg, taken orally on an empty stomach before breakfast once a day (the daily medication time should be the same as much as possible), delivered in warm water, continuously used for 2 weeks and stopped for 1 week, with a treatment cycle of 3 weeks.
Gemcitabine injection: Intravenous infusion of 1000mg/m2, administered on the 1st and 8th days of each cycle, 3 weeks per cycle for 4-6 cycles.
Antitinib Hydrochloride CapsulesDrug
10 mg, taken orally on an empty stomach before breakfast once a day (the daily medication time should be the same as much as possible), delivered in warm water, continuously used for 2 weeks and stopped for 1 week, with a treatment cycle of 3 weeks.
GemcitabineDrug
Intravenous infusion of 1000mg/m2, administered on the 1st and 8th days of each cycle, 3 weeks per cycle for 4-6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental: The dosage of penplimab injection is 200 mg per session, administered on the first day of each cycle, Q3W Receives: Drug: Penplimab Injection; Drug: Antitinib Hydrochloride Capsules; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
PFS defined as the time from the first dose until the first documented progressive disease (PD) or death from any cause.
Measured: Baseline up to 2 years
Secondary outcomes (8)
Objective Response Rate（ORR）
Percentage of subjects achieving complete response (CR) and partial response (PR)
Measured: Baseline up to 2 years
Disease Control Rate (DCR)
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD)
Measured: Baseline up to 2 years
Overall survival (OS)
OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up
Measured: Baseline up to 2 years
Time to Response (TTR)
TTR defined as the time from randomization to the first recorded CR or PR
Measured: Baseline up to 2 years
Duration of Response (DOR)
DOR defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first.
Measured: Baseline up to 2 years
PD-L1 expression
Evaluating the correlation between PD-L1 expression and efficacy in tumor tissue samples.
Measured: Tumor tissue samples must be provided to the research center prior to initial administration
Blood EBV level
Evaluate the correlation between the copy number of EBV DNA in the blood of subjects and their efficacy.
Measured: Baseline up to 2 years
Evaluate the health-related quality of life (HRQoL) of subjects
Evaluate the health-related quality of life (HRQoL) of subjects using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire scale。The minimum values is 1，the maximum values is 4，and whether higher scores mean a worse outcome.
Measured: Baseline up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start7 Jul 2023
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Nasopharyngeal CarcinomaStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Xiaozhong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chen Xiaozhong, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886347
- Sponsor's protocol ID
- ALTN-AK105-Ib-02
- Status last verified
- Mar 2025
- First submitted
- 11 Jul 2023
- Last updated
- 20 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penpulimab Plus Gemcitabine and Anlotinib in the Treatment of Metastatic Nasopharyngeal Cancer, A Single Arm, Open-label, Phase Ib Clinical Trial
- ClinicalTrials.gov ID
- NCT06886347
- Acronym / sponsor ID
- ALTN-AK105-Ib-02
- Conditions
- Metastatic Nasopharyngeal Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Chen XiaozhongUniversity, hospital or other
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 20 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.
To evaluaate the efficacy and safety of the regimen incuding Penpulimab, Gemcitabine and Anlotinib in the treatment of metastatic nasopharyngeal carcinoma. Using Progression-Free-Survival as the primary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Penplimab Injection, Drug: Antitinib Hydrochloride Capsules, Drug: GemcitabineExperimental: The dosage of penplimab injection is 200 mg per session, administered on the first day of each cycle, Q3W |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The participants voluntarily signed an informed consent form.
- Age of ≥ 18 years and ≤ 75 years at the time of enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- xpected survival of ≥ 3 months.
- Histologically or cytologically confirmed diagnosis of stage IVb NPC (AJCC 8th).
Key exclusion criteria (9 listed)
- ubjects have had another malignancy within 3 years before the first dose, except nasopharyngeal carcinoma. Subjects with other malignancies that have been cured by local therapy such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervix or breast carcinoma in situ are not excluded.
- Participation in treatment with an investigational drug or use of an investigational device within 4 weeks before first study dosing.
- Palliative local treatment was performed for non target lesions within 2 weeks before the first administration; Received nonspecific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc., excluding IL-11 for the treatment of thrombocytopenia) within 2 weeks before the first administration; Received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week before the first administration.
- Progression during or within 6 months after receiving systemic treatment for locally advanced disease (including induction therapy, concurrent radiotherapy, adjuvant therapy) (excluding oral single agent chemotherapy maintenance).
- Patients with local recurrence and distant metastasis after radical treatment for locally advanced disease.
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 |
|---|---|---|
| Penplimab InjectionPenplimab Injection: Intravenous infusion of Penplimab 200 mg Q3W, with a 3-week treatment cycle. Anlotinib Hydrochloride Capsules: 10 mg, taken orally on an empty stomach before breakfast once a day (the daily medication time should be the same as much as possible), delivered in warm water, continuously used for 2 weeks and stopped for 1 week, with a treatment cycle of 3 weeks. Gemcitabine injection: Intravenous infusion of 1000mg/m2, administered on the 1st and 8th days of each cycle, 3 weeks per cycle for 4-6 cycles. | Drug | Experimental group |
| Antitinib Hydrochloride Capsules10 mg, taken orally on an empty stomach before breakfast once a day (the daily medication time should be the same as much as possible), delivered in warm water, continuously used for 2 weeks and stopped for 1 week, with a treatment cycle of 3 weeks. | Drug | Experimental group |
| GemcitabineIntravenous infusion of 1000mg/m2, administered on the 1st and 8th days of each cycle, 3 weeks per cycle for 4-6 cycles. | Drug | Experimental group |
Primary outcome
PFS
Time frame: Baseline up to 2 years
PFS defined as the time from the first dose until the first documented progressive disease (PD) or death from any cause.
8 secondary outcomes
Objective Response Rate（ORR）
Time frame: Baseline up to 2 years
Disease Control Rate (DCR)
Time frame: Baseline up to 2 years
Overall survival (OS)
Time frame: Baseline up to 2 years
Time to Response (TTR)
Time frame: Baseline up to 2 years
Duration of Response (DOR)
Time frame: Baseline up to 2 years
PD-L1 expression
Time frame: Tumor tissue samples must be provided to the research center prior to initial administration
Blood EBV level
Time frame: Baseline up to 2 years
Evaluate the health-related quality of life (HRQoL) of subjects
Time frame: Baseline up to 2 years
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 20 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Penplimab Injection, Antitinib Hydrochloride Capsules and Gemcitabine in people with Metastatic Nasopharyngeal Carcinoma, run by Chen Xiaozhong 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 10 inclusion and 9 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 20 Mar 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 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 Xiaozhong Chen, Doctor (0571-88128202, chenxz@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Baseline up to 2 years). 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 20 Mar 2025.