NCT06963697Available不适用
Expanded Access To Neoantigen Synthetic Long Peptide Vaccines in Patients With Local Or Metastatic Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Available
- 试验地点
- 1
研究概览
简要总结
This is an intermediate patient expanded access protocol for treatment of patients with local or metastatic solid tumors with a neoantigen synthetic long peptide vaccine.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must satisfy the following criteria to be enrolled in the protocol:
- •Main Inclusion Criterion:
- •1. Patient who qualifies for treatment under 21 CFR 312.305 based on treating physician judgment, inability to enroll in study JLF-200, must have received or be ineligible for FDA-approved therapies for their specific cancer type, and an estimated 5-year survival of less than 50%.
- •Other Inclusion Criteria:
- •>= 12 years of age.
- •ECOG performance status ≤ 2 or Karnofsky score of >=
- •Adequate organ function allowing favorable benefit to risk ratio per the treating physician
- •Systemic corticosteroid therapy is permitted provided dosing is no greater than 4 mg per day (dexamethasone or equivalent) on the day of vaccine administration.
- •Ability to understand and willingness to sign an IRB approved written informed consent document.
排除标准
- •History of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty or known allergy to a component of the neoantigen synthetic long peptide vaccine.
- •Intercurrent illness requiring chronic use of medications that may interfere with rescue medications for treatment of vaccine-related anaphylaxis or attenuate immune response to vaccine treatment (immunosuppressive therapies).
- •Psychiatric illness or social situations that would limit compliance with study requirements.
- •History of pre-existing immunodeficiency disorder or autoimmune condition requiring immunosuppressive therapy that would preclude response to vaccine.
- •Females of childbearing potential may participate provided they agree to practice abstinence; and, if heterosexually active, agree to use at least 2 highly effective contraceptive methods throughout the study and for 3 months following the last dose of study drug; and have a negative serum pregnancy test.
- •6. Females of non-childbearing potential must be post-menopausal or have been surgically sterilized.
- •7. Male subjects with a female partner of childbearing potential must agree to practice abstinence or to use a physician-approved contraceptive method throughout the study and for 3 months following the last dose of study drug.
研究者
研究点 (1)
Loading locations...
相似试验
Available
不适用
Expanded Access to Ensartinib for Participants With ALK+ NSCLCALK Gene Rearrangement PositiveNon-Small Cell Lung CancerNCT04146571Xcovery Holdings, Inc.
Available
不适用
Expanded Access Program of Neladalkib (NVL-655) for Patients With Advanced ALK+ NSCLC or Other ALK+ Solid TumorsNCT06834074Nuvalent Inc.
Approved For Marketing
不适用
Treatment Use Study With Sunitinib (SU011248) For Patients With Cytokine-Refractory Metastatic Renal Cell CarcinomaCarcinoma, Renal CellNCT00130897Pfizer
Available
不适用
Expanded Access Use of L-MTP-PE for the Treatment of OsteosarcomaOsteosarcomaNCT04571229Memorial Sloan Kettering Cancer Center
Available
不适用
Expanded Access to TriheptanoinLong Chain Fatty Acid Oxidation DisordersNCT03773770Ultragenyx Pharmaceutical Inc