A 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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат tolododekin alfa
  Participants will receive tolododekin alfa as an intratumoral injection every 3 weeks (Q3W).
• Препарат Cetrelimab
  Participants will receive cetrelimab Q3W.

Первичные конечные точки

• Objective Response Rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Срок оценки: 6 months]
• Duration of Response (DoR) [Срок оценки: 6 months]
• Disease Control Rate (DCR) [Срок оценки: 6 months]
• Progression Free Survival (PFS) [Срок оценки: 6 months]
• Overall Survival (OS) [Срок оценки: 6 months]
• Lesion-level response in injected and noninjected lesions [Срок оценки: 6 months]
• Measure of area under the plasma concentration-time curve (AUC) of tolododekin alfa [Срок оценки: 6 months]
• Measure of maximum plasma concentration (Cmax) of tolododekin alfa [Срок оценки: 6 months]
• Measure of time to maximum concentration (Tmax) of tolododekin alfa [Срок оценки: 6 months]
• Measure of volume of distribution adjusted for bioavailability (Vd/F) of tolododekin alfa [Срок оценки: 6 months]
• Measure of terminal half-life (t1/2) of tolododekin alfa [Срок оценки: 6 months]
• Incidence of treatment-emergent anti-drug antibodies (ADA) of tolododekin alfa [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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 at least 2 forms of highly effective methods of contraception
• All 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 to ≤ Grade 1 prior to C1D1.
• Willingness to provide fresh tumor biopsy specimens
• Capable of understanding and complying with protocol requirements
• Provides written informed consent for the study

Критерии исключения

• Cohort A only: Participants with Grade 3 or higher 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 toC1D1
• Have received live vaccines within 28 days prior to C1D1
• Have primary or acquired immunodeficient states
• Women of childbearing potential who has a positive serum pregnancy test prior to C1D1 or female participant who is breastfeeding
• Have a history of allogeneic tissue/solid organ transplant
• Has known active uncontrolled 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 within the previous 5 years
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• Community Health Network — Indianapolis
• Barbara Ann Karmanos Cancer Hospital — Detroit
• Roswell Park Comprehensive Cancer Center — Buffalo
• Icahn School of Medicine at Mount Sinai — New York
• FirstHealth of the Carolinas — Pinehurst

Идентификаторы

NCT: NCT07027514 · ANK-101-004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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