jRCT2031220585进行中（未招募）不适用
A phase I/Ib, open-label, multi-center, study of QEQ278 in patients with advanced solid tumors
Novartis Pharma. K.K.0 个研究点目标入组 9 人开始时间: 2023年5月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 9
- 主要终点
- Safety
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Signed informed consent must be obtained prior to participation in the study.
- •Adult men and women >= 18 years of age.
- •Histologically confirmed and documented advanced malignancies (locally advanced malignancies, non-curable by surgery or radiotherapy and metastatic disease). Disease must be measurable, including presence of at least one measurable lesion, as determined by RECIST v1.
- •In the opinion of the treating investigator, patients must have received, but are not benefitting from standard therapies, be intolerant or ineligible to receive such therapy, or have no standard therapy option for the respective disease types (diseases listed below), as well as any other therapies deemed to be standard by local/institutional standard.
- •Non-small cell lung cancer
- •Esophageal squamous cell carcinoma
- •Renal cell carcinoma
- •HPV-associated head and neck squamous cell carcinoma
- •Must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines. The patient must be willing to undergo a new tumor biopsy at screening and during treatment.
排除标准
- •Active previously documented or suspected autoimmune disease. Patients with vitiligo, type I diabetes, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur should not be excluded. Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded.
- •Patients with a history of or current interstitial lung disease or pneumonitis >= Grade
- •Patients who discontinued prior anti-PD-1 therapy due to an anti-PD-1-related toxicity
- •Clinically significant cardiac disease or risk factors at screening
- •Insufficient bone marrow function at screening:
- •Infections:
- •Known history of testing positive for Human Immunodeficiency Virus infection.
- •Active Hepatitis B and / or Hepatitis C.
- •Active, documented COVID-19 infection
- •Known history of tuberculosis
- •Any serious uncontrolled infection (acute or chronic).
- •Systemic chronic steroid therapy (>10 mg/day prednisone or equivalent) or any immunosuppressive therapy, other than replacement-dose steroids in the setting of adrenal insufficiency, within 7 days of the first dose of study treatment. Topical, inhaled, and ophthalmic steroids are allowed.
结局指标
主要结局
Safety
时间窗: dose limiting toxicity evaluation period
Incidence and nature of dose limiting toxicities during the dose limiting toxicity evaluation period for single agent QEQ278. Incidence and severity of adverse events and serious adverse events, including changes in laboratory values, vital signs, and electrocardiograms
Tolerability
Dose interruptions, reductions, and dose intensity
Safety (Dose expansion part)
时间窗: dose limiting toxicity evaluation period
Incidence and nature of dose limiting toxicities during the dose limiting toxicity evaluation period. Incidence and severity of adverse events and serious adverse events, including changes in laboratory values, vital signs, and electrocardiograms
Tolerability (Dose expansion part)
Dose interruptions, reductions, and dose intensity
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
A study to investigate the safety and tolerability of dostarlimab in adult participants with chronic HBV infection on nucleos(t)ide analogue (NA) treatment2023-509027-41-00Glaxosmithkline Research & Development Limited23
招募中
不适用
A Study to investigate the safety and tolerability of sirolimus in patients with primary immunodeficiencyjRCTs03123029620
进行中（未招募）
不适用
A study investigating the safety and tolerability of deferiprone in patients with Friedreich's Ataxia - NDpatients affected by Friedreich AtaxiaMedDRA version: 9.1Level: LLTClassification code 10017374Term: Friedreich's ataxiaEUCTR2007-003331-23-ITAPOPHARMA INC., TORONTO, ONTARIO80
已完成
1 期
A programme to develop a skin patch containing two medicines (physostigmine and hyoscine), Study 6: Assessment of blood levels of the two medicines and any associated symptoms in healthy female participants.ISRCTN15358284Dstl36
已完成
不适用
A study to investigate safety, tolerability, and pharmacokinetics of AZD7503 in healthy Japanese participants.nonalcoholic fatty liver diseasejRCT2071230075Astrazeneca K.K12