NCT07027514招募中1 期
A Phase 1b, Two-Part Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1/PD-L1 Antibody in Participants With Advanced Non-Small Cell Lung Cancer
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 16
- 主要终点
- Objective Response Rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
研究概览
简要总结
A study of tolododekin alfa (also known as ANK-101) administered in combination with an anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) antibody in participants with advanced or metastatic non-small cell lung cancer (NSCLC). Cohort A will enroll participants who have progressed on prior standard of care treatment with an anti-PD-1/PD-L1 antibody and a platinum-based chemotherapy regimen. Cohort B will enroll participants who are treatment-naïve for locally advanced or metastatic NSCLC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have confirmed locally advanced or metastatic NSCLC
- •Thyroid-stimulating hormone (TSH) within normal limits
- •Have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- •Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1
- •Have a life expectancy > 12 weeks
- •Have baseline electrocardiogram (ECG) without evidence of acute ischemia or prolonged QT interval
- •Heterosexually active women of childbearing potential (WOCBP) must agree to use highly effective methods of contraception
- •Male participants who are not sterile must commit to the use of a reliable method of birth control or abstinence
- •Human immunodeficiency virus (HIV)-infected participants must be on anti-retroviral therapy (ART) and have well-controlled HIV infection/disease
- •Resolution of all prior anticancer therapy toxicities prior to C1D
- •Willingness to provide fresh tumor biopsy specimens
- •Capable of understanding and complying with protocol requirements
- •Provides written informed consent for the study
排除标准
- •Cohort A only: Participants with toxic effects to manage adverse events from previous treatment with immunotherapy
- •Cohort B only: Prior therapy with an immune checkpoint inhibitor.
- •Have known EGFR or ALK mutations
- •Have had prior treatment with recombinant interleukin-12 (IL-12)
- •Have received short-term systemic therapy with immunosuppressive agents prior to C1D1
- •Have active autoimmune disease or medical conditions requiring chronic steroid or other immunosuppressive therapy prior to C1D1
- •Have received live vaccines prior to C1D1
- •Have primary or acquired immunodeficient states
- •Female participant who is pregnant or breastfeeding
- •Have a history of allogeneic tissue/solid organ transplant
- •Has active hepatitis B virus (HBV) or hepatitis C virus (HCV).
- •HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
- •Have known active central nervous system metastases
- •Have congestive heart failure, active coronary artery disease, unevaluated new onset angina, unstable angina, or clinically significant cardiac arrhythmias.
- •Have uncontrolled bleeding disorders prior to C1D1
- •Participants on coumadin (warfarin), due to potential for increased bleeding risk associated with surgery
- •History of noninfectious pneumonitis
- •Cohort A only: History of allergy to protein-based therapies, history of any significant drug allergy, or known allergies, hypersensitivity, or intolerance to cetrelimab excipients OR Cohort B only: Hypersensitivity to any component of the anti-PD-1/PD-L1 antibody selected as standard of care
- •Have other systemic conditions or organ abnormalities that may interfere with the conduct of the study
- •Have any acute or chronic psychiatric problems or substance abuse disorder that make the participant unsuitable for participation
研究组 & 干预措施
Cohort A
Experimental
Participants will receive up to 8 cycles of tolododekin alfa in combination with cetrelimab given for up to 1 year
干预措施: tolododekin alfa (Drug)
Cohort A
Experimental
Participants will receive up to 8 cycles of tolododekin alfa in combination with cetrelimab given for up to 1 year
干预措施: Cetrelimab (Drug)
Cohort B
Experimental
Participants will receive up to 8 cycles of tolododekin alfa in combination with the Investigator's choice of a Food and Drug Administration (FDA)-approved anti-PD-1/PD-L1 antibody given according to the FDA-approved label
干预措施: tolododekin alfa (Drug)
结局指标
主要结局
Objective Response Rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
时间窗: 6 months
Percentage of participants with complete response (CR) or partial response (PR) among all response evaluable participants
次要结局
- Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(6 months)
- Duration of Response (DoR)(6 months)
- Disease Control Rate (DCR)(6 months)
- Progression Free Survival (PFS)(6 months)
- Overall Survival (OS)(6 months)
- Lesion-level response in injected and noninjected lesions(6 months)
- Measure of area under the plasma concentration-time curve (AUC) of tolododekin alfa(6 months)
- Measure of maximum plasma concentration (Cmax) of tolododekin alfa(6 months)
- Measure of time to maximum concentration (Tmax) of tolododekin alfa(6 months)
- Measure of volume of distribution adjusted for bioavailability (Vd/F) of tolododekin alfa(6 months)
- Measure of terminal half-life (t1/2) of tolododekin alfa(6 months)
- Incidence of treatment-emergent anti-drug antibodies (ADA) of tolododekin alfa(6 months)
研究者
研究点 (16)
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相关资讯
Ankyra Therapeutics Appoints Sailaja Battula as Chief Scientific Officer to Lead Immuno-Oncology Pipeline- Ankyra Therapeutics has appointed Sailaja Battula, PhD as Chief Scientific Officer, bringing over a decade of experience in immuno-oncology and drug discovery to the clinical-stage biotechnology company.
- Dr. Battula previously held leadership roles at Immuneering Corporation and Bicycle Therapeutics, where she led pioneering work on bicyclic peptides as T cell agonists and tumor-targeting bispecifics.
- The appointment comes as Ankyra advances its lead candidate Tolododekin alfa (ANK-101), an anchored drug conjugate that delivers IL-12 locally to tumors while avoiding systemic toxicity.
- ANK-101 is currently being evaluated in first-in-human clinical trials for advanced solid tumors and non-mutated metastatic non-small cell lung cancer.9 months agoAnkyra Therapeutics Initiates Phase 1b Trial of Anchored IL-12 Immunotherapy Combined with Checkpoint Blockade in Lung Cancer- Ankyra Therapeutics has dosed the first patient in its Phase 1b LANTERN trial evaluating tolododekin alfa, an anchored IL-12 drug conjugate, combined with anti-PD-1/PD-L1 checkpoint blockade in non-small cell lung cancer patients.
- The study will assess both first-line treatment in patients with tumor proportion scores ≥50% and second-line treatment in patients who progressed after initial therapy for metastatic, non-mutated NSCLC.
- Previous Phase 1 monotherapy data published in Nature Communications demonstrated clinical activity with no dose-limiting toxicity in heavily pre-treated solid tumor patients.
- The anchored drug conjugate technology enables prolonged local IL-12 delivery to tumors while minimizing systemic toxicity, potentially addressing limitations of traditional IL-12 therapy.10 months ago