NCT04183166进行中（未招募）1 期
A Randomized Phase I/II Trial in Patients With Newly Diagnosed, Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) Evaluating a Mutanome-directed Immunotherapy.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Transgene
- 入组人数
- 80
- 试验地点
- 14
- 主要终点
- Phase I: Safety and tolerability (Adverse Event reported per CTCAE v5)
研究概览
简要总结
This is a multicenter, open-label, two arms, randomized, phase I/II study evaluating the safety and tolerability as well as some activity parameters of TG4050 in patients with squamous cell carcinoma of the head and neck (SCCHN).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Newly diagnosed stage III or IV, amenable to surgery (AJCC 8th edition) squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
- •Female or male patients, aged at least 18 years
- •Patients in Complete Response after treatment of their primary tumor.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or
- •Adequate hematological, hepatic and renal functions
排除标准
- •Patients with carcinoma of the nasopharynx, squamous cell-carcinoma of unknown primary, squamous cell carcinoma that originates from the skin and salivary gland or paranasal sinus, non-squamous histologies.
- •Prior exposure to anti-cancer vaccines and any antibody targeting T-cell co-regulatory proteins such as anti-PD1, anti-PDL1 or anti-CTLA4 antibodies.
- •Other active malignancy requiring concurrent systemic intervention.
- •Patients with previous malignancies other than the target malignancy to be investigated in this trial
- •Known history of positive testing for Human Immunodeficiency Virus (HIV) or known Acquired Immune Deficiency Syndrome (AIDS)
- •Clinical or laboratory history or evidence of Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) indicating acute or chronic infection
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 10 mIU/mL)
- •Treatment with another investigational agent since the beginning of the screening period
- •Uncontrolled intercurrent illness
研究组 & 干预措施
Arm A : Early study treatment initiation
Experimental
TG4050 treatment initiation at completion of primary treatment
干预措施: TG4050 (Drug)
Arm B: Study treatment initiation at recurrence
Experimental
TG4050 treatment initiation at the time of recurrence
干预措施: TG4050 (Drug)
结局指标
主要结局
Phase I: Safety and tolerability (Adverse Event reported per CTCAE v5)
时间窗: Up to 2 Years.
Incidence of Adverse Event reported per CTCAE v5.
Phase I/II: Disease-Free Survival
时间窗: Up to 2 years.
Time from randomization to documented recurrence of disease.
次要结局
- Phase I/II: Distant Metastases-Free Survival(Up to 2 years.)
- Phase I: Tumor response rate(Up to 2 years.)
- Phase I/II: Overall Response Rate in patients with recurrent disease(Up to 2 years.)
- Phase I/II: Safety and tolerability (Adverse Event reported per CTCAE v5)(Up to 2 years.)
- Phase I: Disease-Free Survival(Up to 2 Years.)
- Phase I/II: Loco-Regional Relapse-Free Survival(Up to 2 years.)
研究者
研究点 (14)
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相关资讯
Transgene's TG4050 Achieves 100% Two-Year Disease-Free Survival in Head and Neck Cancer Phase I Trial- Transgene's individualized neoantigen vaccine TG4050 demonstrated 100% two-year disease-free survival when used as adjuvant monotherapy in patients with high-risk, resected HPV-negative head and neck squamous cell carcinoma.
- The Phase I trial showed TG4050 induced neoantigen-specific T cell responses in 73% of evaluable patients, with durable cytotoxic and effector responses lasting up to one year after treatment completion.
- The comprehensive clinical and translational data from the randomized Phase I/II trial have been published as a preprint on medRxiv, supporting TG4050's potential to prevent cancer relapse through personalized immunotherapy.
- TG4050 was well-tolerated with no unexpected safety signals, and the vaccine encodes up to 30 predicted tumor neoantigens delivered via Modified Ankara Virus vector technology.8 months agoTransgene's TG4050 Shows Promise in Head and Neck Cancer Trial- Transgene's TG4050 demonstrated a strong clinical proof of principle in adjuvant head and neck cancer, with all 16 patients remaining disease-free after 24.1 months.
- The TG4050 vaccine induced specific immune responses against personalized antigen targets, showing strong immunogenicity and sustained immune responses over seven months.
- BT-001, Transgene's oncolytic virus, induced tumor regression in patients unresponsive to prior anti-PD(L)-1 treatment, both as a monotherapy and in combination with pembrolizumab.
- Transgene confirms financial visibility into Q4 2025, enabling continued progress and news flow on its immunotherapy portfolio.last yearTransgene and NEC's TG4050 Shows Sustained Disease-Free Survival in Head and Neck Cancer Trial- TG4050, an individualized immunotherapy, demonstrates 100% disease-free survival at 24.1 months in head and neck cancer patients after standard adjuvant therapy.
- The neoantigen cancer vaccine induced immune responses targeting selected neoantigens in all treated patients, showing strong and sustained immunogenicity.
- The ongoing Phase I/II trial is expanding internationally, with Phase II currently enrolling patients to further confirm these promising findings.
- TG4050 combines Transgene's myvac platform with NEC's AI to personalize cancer treatment by stimulating the immune system against tumor-specific mutations.last yearTransgene and NEC's TG4050 Cancer Vaccine Shows Sustained Disease-Free Survival in Head and Neck Cancer Trial- TG4050, an individualized immunotherapy, demonstrates a 100% disease-free rate in head and neck cancer patients after a median follow-up of 24.1 months.
- The Phase I trial data highlights the vaccine's strong immunogenicity, with immune responses targeting selected neoantigens observed in all patients.
- The ongoing trial has been expanded to a Phase I/II study to further evaluate TG4050's efficacy in preventing relapse in this high-risk patient population.
- TG4050 leverages Transgene's myvac® platform and NEC's AI to optimize antigen selection, offering a personalized approach to cancer treatment.last yearTG4050 Neoantigen Vaccine Shows Sustained Disease-Free Survival in Head and Neck Cancer Trial- A Phase I trial of TG4050 in head and neck cancer showed that all patients treated with the vaccine after standard care remained disease-free after 24.1 months.
- The individualized immunotherapy induced specific and sustained immune responses against selected neoantigens in all treated patients, demonstrating strong immunogenicity.
- Based on these promising results, the trial has been expanded into a Phase I/II study, with the Phase II portion currently enrolling patients internationally.
- The neoantigen cancer vaccine TG4050 demonstrates potential to prevent relapse in patients with locally advanced resected head and neck squamous cell carcinoma (HNSCC).last year
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