CTIS2023-507536-21-00进行中（未招募）1 期
A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination with an Immune Checkpoint Inhibitor in Patients with Advanced Solid Tumors - MDNA11-01
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 115
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
- •Aged at least 18 years (inclusive at the time of informed consent)., Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and within 72 hours before the first dose of study drug(s). Women must not be breastfeeding. Note: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required., Agree to use highly effective contraception methods. WOCBP must agree to use birth control (defined as those, alone or in combination, that result in a low failure rate [i.e., < 1% per year] when used consistently and correctly, such as oral contraceptives, surgical sterilization, an intrauterine device, and/or 2-barrier methods [e.g., condom and cervical barrier such as a diaphragm]). Protections against pregnancy must be continued for at least 6 months after the last dose of study drug. This criterion may be waived for males who have had a vasectomy > 6 months before signing the ICF. Males must agree to refrain from sperm donation during the treatment period and for at least 6 months after the last dose of study drug(s). N.B. WOCBP are defined as those who are not surgically sterile or post-menopausal. Females will be considered postmenopausal if they have been amenorrheic for 12 months without an alternative medical cause. Females < 50 years old who meet the criteria for post-menopausal status without previous surgical sterilization should be considered for further investigation with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels to confirm serological post-menopausal status., Criteria for Patient known to be Human Immunodeficiency Virus (HIV) Positive: HIV infected participants must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease defined as: • Participants on ART must have a CD4+ T-cell count >350 cells/mm3 at time of screening; • Participants on ART must have achieved and maintained virologic suppression as evidenced by HIV RNA below the limit of detection at screening and for at least 12 weeks prior to screening; • Participants must be on an approved and stable ART regimen, without changes in drug(s) or dose modification, for at least 8 weeks prior to start of treatment. • HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease are not eligible. All Patients - Consent for Fresh Tumor Biopsies (Optional): Investigators are encouraged to identify patients who are suitable candidates for paired fresh tumor biopsies in which case the following will apply: • Baseline: Fresh biopsy collected within 28 days prior to start of treatment • On-Treatment: Fresh biopsy collected ~1 week after Target Dose 2 or 3 (timing of the on-treatment biopsy may be adapted based on emergent data from the study) Biopsy requirement for patients enrolled in a combination cohort (MDNA11+ pembrolizumab): • Patient must consent to obtaining pre-treatment archival tumor tissue [at least 15 formalin-fixed, paraffin embedded (FFPE) slides or 1 FFPE block], or baseline fresh (i.e., de novo) tumor samples (if archived sample is not available) where safe to do so in accordance with local institutional practice. Cytological or FNA samples are not acceptable. • Patients without any archival tissue, or for whom this is inaccessible, or who refuse to consent to provide archival tissue may be approved to enroll on a case-by-case basis in discussion with the Sponsor., Eastern Cooperative Oncology Group (ECOG) Perfor
排除标准
- •Last administration of prior antitumor therapy: • Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment. • Has received prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease. • Has received radiation therapy to the lung that is > 30Gy within 6 months prior to start of treatment. • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. • Concomitant participation in an observational study must be discussed on a case-by-case basis with the MM for approval. Note: Patients who have entered the follow-up phase of an investigational study may participate provided it has been 4 weeks after the last dose/use of the previous investigational agent/device., Severe pulmonary, cardiac, or other systemic disease, specifically: a. New York Heart Association = class 2 congestive heart failure within 6 months prior to start of treatment (may be considered , if unless currently asymptomatic and well controlled with medication upon review with MM); b. Uncontrolled or clinically significant cardiovascular disease, i.e., new, uncontrolled, or unstable significant arrhythmia (e.g., sustained ventricular tachycardia), thromboembolic events, treatment resistant hemodynamic instability, severe treatment-resistant uncontrolled hypertension, significant symptomatic restrictive cardiomyopathy and/or constrictive pericarditis. Patients with paroxysmal, persistent or permanent atrial arrythmias are permitted if the rhythm and/or rate (both as appropriate) are adequately controlled; c. Coronary/peripheral artery bypass grafting, myocardial infarction, stroke, unstable angina, or symptomatic pulmonary embolism (PE) within 4 months prior to start of treatment. Clinically stable patients with deep vein thrombosis (DVT) or PE on appropriate therapeutic anticoagulation may be considered on a case-by-case basis; d. Documented LVEF < 40% determined by any appropriate cardiac imaging modality, e.g., echo, CMR, nuclear imaging (SPECT, MUGA). Patients with suboptimal imaging may have LVEF quantified by another modality; e. QT interval corrected for heart rate using Fridericia formula (QTcF) prolongation > 470 msec at screening, except for right or left bundle branch block on discussion with the MM. Patients with congenital long QT to be discussed with the MM; f. Uncontrolled or clinically significant pulmonary disease (such as = Grade 2 dyspnea according to CTCAE 5.0 i.e., shortness of breath with minimal exertion; limiting instrumental ADL or hypoxia [PaO2 < 60 mmHg (8 KPa)] at rest and/or SpO2 or SaO2 < 90% or requirement for supplemental oxygen); N.B. Patients with known or suspected chronic respiratory disease (e.g., asthma, COPD, pulmonary fibrosis), Grade 1 dyspnea (i.e., shortness of breath with moderate exertion), moderate or greater pleural effusion(s), and/or abnormal peripheral/arterial oxygen saturation (SpO2 or SaO2 <95%) must be discussed on a case-by-case basis with the Sponsor to determine eligibility; g. Patients with a diagnosis of adrenal insufficiency or severe autonomic failure. Those with suspected potential adrenal insufficiency or au
研究者
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