EUCTR2021-005136-34-BG进行中（未招募）1 期
A Multicenter, Open-Label, Dose-Finding, Phase 2 Study Evaluating THIO Sequenced with Cemiplimab (LIBTAYO®) in Subjects with Advanced Non-Small Cell Lung Cancer (NSCLC) - THIO-101
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 176
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
- 性别
- All
入选标准
- •1. At least 18 years of age at the time of signing the Informed Consent Form (ICF) prior to initiation of any study specific activities/procedures.
- •2. Stage 3 or 4 histologically or cytologically confirmed NSCLC which has progressed or relapsed after treatment in the advanced setting
- •Stage 4 subjects – must have progressed or relapsed after first line treatment.
- •Stage 3 subjects – must have already failed, or be ineligible for, local,
- •curative-intent therapy including surgery and/or chemoradiation. Stage 3 subjects with documented relapse/progression after consolidation therapy with durvalumab following definitive chemoradiotherapy are eligible.
- •Patients with primary resistance, as defined by the Society for
- •Immunotherapy of Cancer (SITC) immunotherapy resistance task force,
- •are excluded:
- •Subjects with drug exposure >6 weeks who achieved a PR or CR,
- •then progressed before 6 months would still be eligible.
- •3. Only one prior treatment for NSCLC in the advanced setting, which must have included one anti-PD-1/PD-L1 agent with documented radiographic disease progression on or after treatment.
- •Prior treatment may have been with anti-PD-1/PD-L1 agent either alone or in combination with a non-anti-PD-1/PD-L1 treatment (e.g., chemotherapy).
- •Prior platinum-based chemotherapy is not required for eligibility.
- •Subjects receiving more than one ICI in the advanced setting (e.g., anti-PD-1/PD-L1 and anti-CTLA-4 compounds) will not be eligible.
- •4. At least one measurable target lesion that meets the definition of
- •RECIST v1.1.
- •5. An archival tissue sample (FFPE tissue block or unstained slides) is
- •required if tissue is available at baseline. Sample does not need to be
- •received by central lab prior to C1D1. Subjects without archival tissue
- •available at baseline may be eligible with medical monitor approval.
- •Diagnostic Assessments
- •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •7. Demonstrate adequate organ function as defined below. All screening
- •laboratories should be performed up 14 days before initiating IP:
- •Bone marrow function: neutrophil count = 1500/mm3, hemoglobin
- •= 9.0 g/dL, platelet count = 100,000/mm3;
- •Liver function:
- •Total bilirubin = 1.5 x the upper limit of normal (ULN), up to = 3
- •x ULN due to Gilbert's syndrome
- •Alanine aminotransferase (ALT) and aspartate aminotransferase
- •(AST) = 1.5 xULN. For subjects with liver metastases present at
- •baseline, ALT and/or AST= 3xULN iis permitted.
- •Renal function: Creatinine clearance = 60 mL/min calculated by the
- •Cockcroft-Gault formula using actual body weight or 24-hour urine
- •collection.
- •Gender and Reproductive Considerations
- •8. Women of childbearing potential (WOCBP) must have negative serum
- •pregnancy test (minimum sensitivity 25 IU/L or equivalent units of
- •human chorionic gonadotropin [HCG]) within 72 hours prior to receiving
- •the first administration of IP.
- •9.Contraception use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •10. WOCBP must agree to use a highly effective birth control and refrain
- •from oocyte donation during the study (prior to the first dose with THIO,
- •for the duration of the treatment with THIO plus 6 months after last dose
- •of IP), if conception is possible during this interval.
- •11. Male subjects and WOCBP partners of male subjects should use a
- •combination of the methods specified in Section 10.4 for the women
- •along with a male condom from first dos
排除标准
- •Medical Conditions
- •1. Have not recovered from adverse events (must be Grade =1) due to prior anti-cancer
- •2. Untreated or symptomatic central nervous system (CNS) metastases.
- •Note: subjects with treated asymptomatic brain metastasis are eligible.
- •3. Active gastrointestinal bleeding as evidenced by either hematemesis or melena.
- •4. History of another concurrent malignancy other than the present condition (except
- •nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission
- •and off all therapy for that disease for a minimum of 3 years.
- •5. A condition requiring systemic treatment with either corticosteroids (> 10 mg daily
- •prednisone equivalents) or other immunosuppressive medications within 14 days of study
- •drug administration. Inhaled or topical steroids, adrenal replacement doses 10 mg daily
- •prednisone equivalents, and systemic corticosteroids to manage adverse events (AEs) are
- •permitted in the absence of active autoimmune disease.
- •6. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy within
- •2 weeks of screening.
- •7. Positive for Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active hepatitis B
- •or hepatitis C.
- •8. Significant cardiovascular impairment (history of New York Heart
- •Association Functional Classification System Class III or IV) or a history
- •of myocardial infarction or unstable angina within the past 6 months
- •prior to IP initiation.
- •a) QTcF > 480 msec at screening (based on average of triplicate ECGs at
- •i. If the QTc is prolonged in a subject with a pacemaker or bundle branch
- •block, the subject may be enrolled in the study if confirmed by the
- •medical monitor.
- •9. Ongoing immune-related/stimulated adverse events (irAEs) from
- •other agents or required permanent discontinuation of prior ICIs due to
- •irAEs. Subjects with resolved irAE will be allowed to enroll following
- •consultation with Sponsor's Medical Monitor (or designee).
- •10. Active autoimmune diseases or history of autoimmune diseases that
- •may relapse, with the following exceptions:
- •Controlled type 1 diabetes;
- •Hypothyroidism (provided it is managed with hormone-replacement
- •therapy only);
- •Controlled celiac disease;
- •Skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis,
- •or alopecia);
- •Any other disease that is not expected to recur in the absence of
- •external triggering factors.
- •11. Pregnancy or lactating.
- •12. A serious nonmalignant disease (e.g., psychiatric, substance abuse,
- •uncontrolled intercurrent illness, etc.) that could compromise protocol
- •objectives in the opinion of the investigator and/or the Sponsor.
- •13. Any other condition that, in the opinion of the investigator, would
- •prohibit the subject from participating in the study.
- •Prior Therapy
- •14. Prior chemotherapy and/or non-biologic targeted therapy within 4
- •weeks, or biologic targeted therapy, immunotherapy and/or radiation
- •therapy within 6 weeks prior to Cycle 1 Day 1. Subjects who receive
- •targeted radiation therapy for localized palliative care may be eligible to
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