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 - H-200-001

Hookipa Biotech GmbH0 个研究点目标入组 2 人开始时间: 待定最近更新: 2024年7月8日

适应症

试验速览

阶段: 2 期
状态: 尚未招募
发起方: Hookipa Biotech GmbH
入组人数: 2

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•All Patients:
•- 18 years of age or older
•- >= 1 measurable lesion by imaging for tumor response following RECIST and
•- 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
•- Female patients who are of childbearing potential must have a negative serum
•β-human chorionic gonadotropin (β-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 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
•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

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 SmPC
•- Allogeneic tissue/solid organ transplant.
•- History of (non-infectious) pneumonitis that required steroids or current
•pneumonitis.

研究者

发起方

Hookipa Biotech GmbH

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