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To Evaluate the Safety and Efficacy of TQB2858 Injection to the Subjects With Recurrent/Metastatic Nasopharyngeal Cancer

NCT05198531 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-01-21

No results posted yet for this study

Summary

This study is a single-arm, randomized, open-label, multi-cohort Phase Ib clinical trial. The experimental drug is TQB2858 Injection. The trial was divided into 3 cohorts. Cohort 1 included patients with advanced nasopharyngeal carcinoma who had previously failed platinum-based chemotherapy and immune checkpoint inhibitors (programmed cell death protein 1 (PD-1)/ Programmed death-ligand 1 (PD-L1), etc.). Cohorts 2 and 3 were randomized into patients with advanced, untreated nasopharyngeal carcinoma who had not received prior systemic therapy. A total of 60-90 subjects are required.

Conditions

  • Recurrent / Metastatic Nasopharyngeal Cancer

Interventions

DRUG

TQB2858 Injection

TQB2858 Injection, a bifunctional fusion protein against Programmed death ligand 1 (PD-LI) and transforming growth factor-β (TGF-β). TQB2858 Injection blocks the PD-1/PD-L1 pathway and neutralizes TGF-β in the tumor microenvironment.

DRUG

Anlotinib Hydrochloride Capsule

Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.

DRUG

Gemcitabine hydrochloride injection

Gemcitabine hydrochloride, cell cycle-specific antimetabolites, mainly acting on tumor cells in the DNA synthesis phase (S phase cell). Under certain conditions, it can prevent the progression from G1 phase to S phase.

DRUG

Cisplatin Injection

After cisplatin enters cells, it reacts with DNA to form cross-links between two points or two strands in DNA, thereby inhibiting DNA replication and transcription, resulting in DNA breaks and miscoding.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2022-10-31
Completion
2023-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05198531 on ClinicalTrials.gov