EUCTR2019-000907-34-ES进行中（未招募）1 期
A Phase I/II Study of TheraT® Vector(s) Expressing Human Papillomavirus 16 Positive (HPV 16+) Specific Antigens in Patients with HPV 16+ Confirmed Cancers
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All Patients:
- •-18 years of age or older
- •-= 1 measurable lesion by imaging for tumor response following RECIST and iRECIST
- •-ECOG performance status of 0 to 1.
- •-Prior curative radiation therapy must have been completed = 4 weeks prior to study treatment administration. Prior focal palliative
- •radiotherapy must have been completed = 2 weeks prior to study treatment administration.
- •-Screening laboratory values must meet protocol-specified criteria Treatment Group 1, Group 3, Group 4, Group 5 Group A, or Group D:
- •-Documentation of confirmed HPV 16+ HNSCC via genotype testing
- •-Tumor progression or recurrence on standard of care therapy, including = 1 systemic therapy or be a patient for whom standard of care therapy is contraindicated.
- •Treatment Group 2, Group 4, Group C, or Group F:
- •-Documentation of confirmed HPV 16+ cancer via genotype testing
- •-Tumor progression or recurrence on standard of care therapy, including = 1 systemic therapy
- •-Safe and accessible tumor site amenable for biopsy and IT administration
- •-Apart from the tumor site(s) amenable for biopsy and IT administration = 1 measurable lesion for RECIST assessment
- •- Female patients who are of childbearing potential must have a negative serum ß-human chorionic gonadotropin (ß-hCG) pregnancy test prior to the first administration of study treatment or be surgically/biologically sterile (hysterectomy or bilateral oophorectomy) or postmenopausal.
- •- Male patients with sexual partners of childbearing potential can participate in the study if they agree to use barrier contraception from signing of the ICF through 5 months after the last study treatment administration.
- •Treatment Group B or Group E:
- •-Documentation of confirmed HPV 16+ HNSCC via genotype testing
- •-Must be eligible, as per standard of care, to receive pembrolizumab
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •-Untreated and/or symptomatic metastatic central nervous system (CNS) disease, and/or carcinomatous meningitis. With some exceptions
- •for treated and stable brain/CNS metastases
- •-Any serious or uncontrolled medical disorder that, in the opinion of the Investigator, may increase the risk associated with study participation /
- •treatment administration
- •-Concurrent malignancy that is clinically significant or requires active intervention
- •-Active, known or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy
- •-Toxicity attributed to systemic prior anticancer therapy, including radiation and surgery, other than alopecia and fatigue that has not
- •resolved to Grade 1 or Baseline prior to the first administration of study
- •-Not meeting the protocol-specified washout periods for prohibited medications per the protocol
- •-Treatment with any chemotherapy, biological, or investigational therapy for cancer within 28 days of the first administration of study treatment.,
- •unless agreed otherwise between the Sponsor and the Investigator on a case-by-case basis based on the half-life of the anticancer therapy.
- •Exception: Ongoing treatment with pembrolizumab is permitted if the subject is enrolling in a backfill cohort continuing pembrolizumab and
- •adding either HB-201 monotherapy or HB-201 & HB-202 alternating two vector therapy.
- •-Prior anaphylactic or other severe reaction to human immunoglobulin or
- •antibody formulation administration
- •-Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
- •antibody, indicating acute or chronic infection
- •-Known history of AIDS.
- •For patients receiving pembrolizumab:
- •-History of severe hypersensitivity reaction to pembrolizumab
- •-Any contraindication to receiving pembrolizumab per package insert or
- •-Allogeneic tissue/solid organ transplant.
- •-History of (non-infectious) pneumonitis that required steroids or current pneumonitis.
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