CTIS2022-503060-33-00进行中（未招募）1 期
A Phase 1/2 Dose Escalation/Expansion Study of NGM707 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies - NGM707-IO-101
gm Biopharmaceuticals Inc.0 个研究点目标入组 120 人开始时间: 2023年3月13日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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 65+（—）
- 性别
- All
入选标准
- •Males or females =18 years of age who comprehend and are willing and able to provide an ICF, and able to comply with scheduled visits, treatment schedule, and laboratory tests, including the other requirements for the study., Women of childbearing potential must agree to use of 2 methods of acceptable contraception from screening until 4 months after the last dose of study drug (see Section 5.4). Acceptable methods of contraception are defined as those that result, alone or in combination, in a low failure rate (ie, less than 1% per year) when used consistently and correctly, such as surgical sterilization, an intrauterine device, or hormonal contraception in combination with a barrier method. In certain countries (if permitted by law), women of childbearing potential may agree to abide by heterosexual sexual abstinence during the time of participation in this study., Males who are sexually active with a female partner of childbearing potential must agree to use a barrier contraception (eg, condom with spermicidal foam/gel/film/cream/suppository) from screening until 4 months following the last dose of study drug, in addition to their female partner using either an intrauterine device or hormonal contraception and continuing until 4 months following the last dose of study drug. This criterion may be waived for male patients who have had a vasectomy >6 months before signing the ICF., An archival tumor biopsy must be provided and should be taken within 1 year of enrollment. If not available, a fresh tumor biopsy is acceptable (see Section 8.7.2.2)., Part 2b Have at least 1 measurable lesion per RECIST v1.1 criteria., Part 2b Disease cohort specific criteria as follows: • Cohort A (2L or 3L Squamous NSCLC) - Histologically or cytologically confirmed diagnosis of advanced/metastatic NSCLC (squamous cell carcinoma subtype); mixed histology (e.g., adeno-squamous) is allowed if there is predominant squamous cell histology in the biopsy specimen. - Received prior anti- PD(L)1-directed therapy plus/minus platinum- or pemetrexedbased doublet chemotherapy, either as combination or in any sequence. No more than 2 prior lines of systemic therapy allowed. • Cohort B (2L or 3L Non-Squamous NSCLC) - Histologically or cytologically confirmed diagnosis of advanced/metastatic NSCLC (predominant cell histology of adenocarcinoma in the biopsy specimen). - Received prior anti- PD(L)1-directed therapy plus/minus platinum- or pemetrexedbased doublet chemotherapy, either as combination or in any sequence. No more than 2 prior lines of systemic therapy allowed. • Cohort C (2L or 3L SCCHN) - Histologically confirmed diagnosis of primary tumor location of oral cavity, oropharynx, hypopharynx, or larynx. Patient may not have a primary tumor site of nasopharynx (any histology). Results from testing of HPV status assessed by P16 with initial diagnosis must be available and recorded for oropharyngeal cancer patients. - Provide fresh baseline biopsy during the screening period. - Received prior anti-PD(L)1-directed therapy plus/minus chemotherapy, either as combination or in any sequence. No more than 2 prior lines of systemic therapy allowed., Histologically or cytologically documented locally advanced or metastatic solid tumor malignancy (see specific histology types for each part of study below), Patients must not be amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy), ECOG PS of =1., Adequate bone mar
排除标准
- •History of prior malignancy other than the cancer under treatment in this study, except for adequately treated in situ cancer, basal cell, or squamous cell skin cancer, or other cancers (eg, breast, prostate) for which the patient has been disease-free for at least 3 years., Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, significant hemoptysis, or melena in the past 6 months, History of allergy or known hypersensitivity to study drug components originated from CHO cells., Inadequately controlled arterial hypertension (approximately above 150 or 100 mmHg in systolic and diastolic pressure, respectively). Consult the Sponsor with any questions. Anti hypertensive therapy to achieve these parameters is allowable, Patients with a history of interstitial lung disease/non infectious pneumonitis that required steroid, radiation pneumonitis, active pulmonary tuberculosis, or evidence of active pneumonitis on screening chest CT scan. Patients with radiation therapy to the lung that is >30 Gy within 6 months of the first dose of treatment are excluded. Patients with active lung infections requiring treatment are also excluded., Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect patient safety or interpretation of study results (eg, baseline QTcF interval >470 msec, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST T interval changes suggestive of active myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias). -If the baseline uncorrected QT interval is >470 msec, this interval should be rate corrected using the QTcF and the resulting QTcF should be used for decision making and reporting (additional details are in the protocol), Any of the following in the previous 6 months: cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, and/or other clinically significant episodes of thromboembolic disease. Venous thromboembolic events that are non–life threatening and stable on low molecular weight heparin or factor Xa inhibitors that can be reversed by andexanet a are allowed., Any of the following in the previous 6 months: myocardial infarction, symptomatic congestive heart failure (NYHA Class >II; see Appendix 2), unstable angina, coronary/peripheral artery bypass graft, or unstable cardiac arrhythmia requiring medication. Ongoing cardiac dysrhythmias of National Cancer Institute (NCI) CTCAE > Grade 2, atrial fibrillation of any grade (> Grade 2 in the case of asymptomatic lone atrial fibrillation). Patients with LVEF <45% as measured by screening echocardiogram or MUGA are not eligible. Patients with cardiac rhythm device/pacemaker must be discussed in detail with Sponsor’s Medical Monitor to judge eligibility, Clinically significant and unmanageable ascites defined as requiring constant therapeutic paracentesis (limited medical treatment to control ascites is permitted, but all patients who received paracentesis within 3 months of expected first dosing date will require review by Sponsor’s Medical Monitor)., Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator, would preclude the patient from adhering to the protocol, Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study drug. Note: Administration of killed vaccines are allowed., Active brain or leptomeningeal met
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