Metastatic Nasopharyngeal Carcinoma

NCT06886347 | Recruiting Phase 1

• 1 other identifier: ALTN-AK105-Ib-02
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• PFS

  PFS defined as the time from the first dose until the first documented progressive disease (PD) or death from any cause.

  Baseline up to 2 years

Secondary Outcomes (8)

• Objective Response Rate（ORR）

  Baseline up to 2 years

• Disease Control Rate (DCR)

  Baseline up to 2 years

• Overall survival (OS)

  Baseline up to 2 years

• Time to Response (TTR)

  Baseline up to 2 years

• Duration of Response (DOR)

  Baseline up to 2 years

Study Arms (1)

Experimental group

EXPERIMENTAL

Experimental: The dosage of penplimab injection is 200 mg per session, administered on the first day of each cycle, Q3W

Drug: Penplimab Injection; Drug: Antitinib Hydrochloride Capsules; Drug: Gemcitabine

Interventions

Penplimab Injection DRUG

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.

Experimental group

Antitinib Hydrochloride Capsules DRUG

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.

Experimental group

Gemcitabine DRUG

Intravenous infusion of 1000mg/m2, administered on the 1st and 8th days of each cycle, 3 weeks per cycle for 4-6 cycles.

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Chen Xiaozhong: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Xiaozhong Chen, Doctor

CONTACT

0571-88128202; chenxz@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief physicians

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: March 20, 2025
• Study Start: July 7, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

CN (1)