2025-522632-14-00招募中2 期
A Phase 1/2 Study to Evaluate STK-012 as a Single Agent and in Combination Therapy in Subjects with Front-line Advanced NSCLC and Other Selected Indications
Synthekine Inc.10 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2025年12月19日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 17
- 试验地点
- 10
- 主要终点
- ORR is the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR) per blinded independent central review (BICR).
研究概览
简要总结
To compare the ORR in 1L PD-L1 negative NSQ NSCLC subjects treated with STK-012 2.25mg + PCT vs. PCT (Arms A vs. C)
研究设计
- 分配方式
- Randomized
- 主要目的
- Part G (PCT ± STK-012)
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent to participate in the study and follow the study procedures.
- •Subjects must have measurable disease by RECIST 1.1 as assessed by the local site investigator or radiology department. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Adequate organ function within 28 days of treatment initiation, as defined by the protocol.
- •Female subjects of childbearing potential must agree to use a highly effective method of birth control, as defined by the protocol.
- •Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours of the first dose of study treatment.
- •Male subjects with female partners of childbearing potential must agree to use highly effective methods of birth control, as defined by the protocol, or a male condom plus spermicide and must refrain from donating sperm during the treatment period and for 180 days after the last dose of study treatment.
- •Female partners (of childbearing potential) of male subjects must also use a highly effective method of birth control, as defined by protocol, during the treatment period and for 180 days after the last dose of study treatment, if the male subject’s only birth control method is male condom plus spermicide.
- •Subjects who received adjuvant, neoadjuvant or consolidation chemotherapy are eligible if the therapy was completed >6 months prior to initiation of study treatment. Subjects must not have received any prior adjuvant, neoadjuvant or consolidation ICI therapy.
- •Subjects are able and willing to complete the entire study according to the applicable study schedule of assessments.
- •Subjects must have histologically or cytologically confirmed diagnosis of stage IV (M1a, M1b or M1c per AJCC 8th edition) or stage IIIB/IIIC (N2 or N3 per AJCC 8th edition) NSQ NSCLC if they are not candidates for definitive treatment.
- •Subject’s tumor must have predominantly non-squamous cell histology NSCLC. Subject’s tumor must not have small cell, neuroendocrine or sarcomatoid components.
- •No known AGAs by tumor or ctDNA testing in EGFR, ALK, or ROS1 or other AGAs for which there is a local SoC available as 1L therapy.
- •Subjects must have a tumor that is negative for PD-L1 (TPS <1%) per local assessment
- •Subjects must not have received prior systemic treatment for their advanced NSQ NSCLC.
- •Male and female subjects age ≥18 years on day of signing ICF.
- •Life expectancy >3 months as determined by the investigator.
排除标准
- •Received systemic anti-cancer therapy within 3 weeks of the first dose of study treatment or small molecule kinase inhibitors within 6 elimination half-lives of the first dose of study treatment.
- •Known active or history of autoimmune disease or a syndrome that requires steroids or immunosuppressive agents. Subjects are permitted to enroll if they have vitiligo, type 1 diabetes mellitus, resolved childhood asthma; residual hypo- or hyperthyroidism due to an autoimmune condition not requiring immunosuppressive treatment; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs).
- •Diagnosis of immunodeficiency or are receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. Exceptions include inhaled or topical corticosteroids or brief courses of corticosteroids given for prophylaxis of contrast dye allergic response are permitted.
- •History of allogenic tissue/solid organ transplant.
- •Clinically significant (ie. active) cardiovascular disease or risk factors at screening, as defined by the protocol.
- •History or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic, or psychiatric) other than their primary malignancy, that in the opinion of the investigator would pose a risk to subject safety or interfere with study evaluations, procedures, or completion.
- •Subjects with uncontrolled intercurrent illnesses, including immune colitis, interstitial lung disease, or a history of immune pneumonitis or pulmonary fibrosis that required oral or intravenous glucocorticoids.
- •Evidence of any serious active bacterial, viral, parasitic, or systemic fungal infections requiring systemic therapy within the 30 days prior to the first dose of study drug.
- •Known additional malignancy that is progressing or has required active treatment within the past 2 years. Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma and CC in situ) that have undergone potentially curative therapy are not excluded.
- •Receipt of a live-virus vaccine within 30 days prior to first dose of study drug and while on study (seasonal flu vaccines and coronavirus disease 2019 [COVID-19] vaccines that do not contain live-virus are permitted).
- •Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.
- •Received radiotherapy ≤ 7 days prior to the 1st dose of study treatment.
- •HIV infection confirmed during the Screening Period by a positive serum HIV test.
- •Active hepatitis B virus infection or hepatitis C virus (HCV) infection confirmed during the Screening Period by a positive hepatitis B surface antigen or positive anti-hepatitis C virus antibody (anti-HCV) test. Exceptions include subjects with a reactive or indeterminate/equivocal anti-HCV test with a negative HCV RNA test.
- •Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, defined as starting with the screening visit through 180 days after the last dose of study treatment.
- •Received prior IL-2-based or IL-15-based cytokine therapy.
- •History of idiopathic pulmonary fibrosis (including pneumonitis), drug or radiation induced pneumonitis, organizing pneumonia (ie, bronchiolitis obliterans and cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan.
- •05.Currently participating in or have participated in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of study treatment. Subjects who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- •Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anti-cancer treatment to Grade ≤
- •Any history of carcinomatous meningitis.
- •Known untreated central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate provided they are clinically stable and without requirement of steroid treatment for at least 7 days prior to first dose of study treatment.
- •Severe hypersensitivity (NCI CTCAE Grade ≥3) to monoclonal antibodies, including pembrolizumab and/or any of its excipients.
结局指标
主要结局
ORR is the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR) per blinded independent central review (BICR).
ORR is the proportion of subjects with confirmed complete response (CR) or confirmed partial response (PR) per blinded independent central review (BICR).
次要结局
- PFS is the time from randomization until the first documentation of disease progression per BICR or death due to any cause, whichever occurs first.
- ORR is the proportion of subjects with confirmed CR or confirmed PR per BICR.
- OS is the time from randomization until death due to any cause.
- Safety including but not limited to: TEAEs, SAEs, deaths, and clinical laboratory abnormalities per NCI CTCAE v5.0 except for CRS, which will be graded according to the ASTCT guidelines.
- Incidence of STK-012 antibodies and qualitative assessment of safety outcomes.
- PK characterization of STK-012 (eg, AUC, Cmax, Tmax, t1/2).
研究者
STK Contact
Scientific
Synthekine Inc.
研究点 (10)
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