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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 34
- 主要终点
- Phase I Dose Escalation: Determine Phase II dose based on incidence of dose-limiting toxicities.
研究概览
简要总结
This is a First in Human (FIH) Phase I/II, multinational, multicenter, open-label study of HB-201 single vector therapy and HB-201 & HB-202 two-vector therapy in patients with HPV 16+ confirmed cancers comprising two parts: Phase I Dose Escalation and Phase II Dose Expansion.
详细描述
HB-201 and HB-202 are study drugs which are designed to train the body to recognize and fight substances found in HPV 16+ cancer. This trial studies the safety and anti-cancer effect of HB-201 and HB-202 in people.
The trial is enrolling patients with metastatic/recurrent head and neck cancer who have not yet received treatment in this setting (1L, first line) and who are eligible to receive pembrolizumab as part of their standard of care. This trial is also enrolling patients with metastatic/recurrent head and neck who have received prior treatment in this setting (2L+, second and later line) who are eligible to receive pembrolizumab as part of their standard of care. Patients will receive the study drugs in addition to their pembrolizumab standard of care regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 未提供
排除标准
- •All patients:
- •Metastatic central nervous system disease, and/or carcinomatous meningitis.
- •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, unless protocol-defined criteria are met.
- •Active, known or suspected, autoimmune or inflammatory disorders requiring immunosuppressive therapy.
- •Has a life expectancy of less than 3 months.
- •Any toxicities attributed to systemic prior anticancer therapy o that have not resolved to Grade 1 or baseline prior to the first administration of study drug, unless protocol-defined criteria is met.
- •Not meeting the protocol-specified washout periods for prohibited medications.
- •Prior anaphylactic reaction to or known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s).
- •Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody, indicating acute or chronic infection.
- •Known history of acquired immunodeficiency syndrome.
- •For patients in Groups E or F and certain backfill cohorts:
- •History of severe hypersensitivity reaction to or other contraindication to receiving pembrolizumab.
- •History of/Presently having non-infectious pneumonitis requiring treatment.
- •Was discontinued due to a Grade 3 or higher immune-related AE (irAE) after receiving prior therapy with check point inhibitors.
- •Imaging Sub-Study (for specific participants at Memorial Sloan Kettering Cancer Center only):
- •Having splenic disorders or prior splenectomy, and can compromise protocol objectives per Investigator and/or Sponsor.
- •Meeting requirements of exclusion criteria for Treatment Group 3
研究组 & 干预措施
Ph I, sub-study
Patients with HPV 16+ HNSCC who had tumor progression or recurrence on standard of care therapy
干预措施: HB-201 or HB-201/HB-202 alternating treatment using CD8 PET Tracer (Zr-Df-IAB22M2C) (Drug)
Ph I, Group 1 and Group 2
Patients with HPV 16+ HNSCC or Non-HNSCC who had tumor progression or recurrence on standard of care therapy.
干预措施: HB-201 intravenous administration. (Drug)
Ph I, Group 3 and Group 4
Patients with HPV 16+ HNSCC or Non-HNSCC who had tumor progression or recurrence on standard of care therapy.
干预措施: HB-202 intravenous administration alternating with HB-201 intravenous administration. (Drug)
Ph II, Group B
Patients with HPV 16+ HNSCC who are eligible to receive immune checkpoint inhibitor as part of standard of care.
干预措施: HB-201 intravenous administration + standard of care regimen including pembrolizumab. (Drug)
Ph II, Group E
Patients with HPV 16+ HNSCC who are eligible to receive pembrolizumab as part of 1L standard of care.
干预措施: HB-202 / HB-201 alternating intravenous administration + standard of care regimen including pembrolizumab. (Drug)
Ph II, Group F
Patients with HPV 16+ cancers who had tumor progression or recurrence on standard of care therapy and who are eligible to receive pembrolizumab as part of 2L+ standard of care..
干预措施: HB-202 / HB-201 alternating intravenous administration + pembrolizumab. (Drug)
结局指标
主要结局
Phase I Dose Escalation: Determine Phase II dose based on incidence of dose-limiting toxicities.
时间窗: From dosing until 21-28 days after first dose
Determine the recommended Phase II dose in terms of safety and tolerability for intravenously administered HB-201, and intravenously administered HB-202 by assessing drug limiting toxicities.
Phase II Dose Expansion: Number of participants with preliminary antitumor activity based on objective response rate.
时间窗: Until progression, (estimated up to 30-months)
Assess the preliminary antitumor activity of dosage regimens of HB-201 and HB-202 using Response Evaluation Criteria in Solid Tumors (RECIST) to determine objective response rate (ORR).
次要结局
- Phase I Dose Escalation: Number of participants with preliminary antitumor activity based on objective response rate and disease control rate.(Until progression, (estimated up to 30-months))
- Phase I Dose Escalation: Number of participants with adverse events (type, frequency, severity).(From informed consent through 30 days after last dose.)
- Phase II Dose Expansion: Number of participants with confirmed duration of preliminary antitumor activity.(Up to 30-months (until progression))
- Phase II Dose Expansion: Number of participants with adverse events (type, frequency, severity).(From informed consent through 30 days after last dose)