A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002)

Официальное название

A Phase 1b/2 Open-Label Clinical Study to Evaluate the Safety and Efficacy of MK-6070 and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer

Обзор

Researchers are looking for new ways to treat people with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory. Gocatamig is a new type of immunotherapy that uses a person's immune system to find and destroy cancer cells. Ifinatamab deruxtecan (also known as I-DXd) is a drug which binds to a specific target on cancer cells and delivers treatment to destroy those cells. Durvalumab is a different type of immunotherapy that also destroys cancer cells. Researchers want to know if giving gocatamig, I-DXd, and gocatamig with I-DXd or durvalumab can treat SCLC that did not respond or stopped responding to a prior treatment. The goals of this study are to learn: * If gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab are safe and well tolerated * If people who receive gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab have their SCLC get smaller or go away

Подробное описание

This study will consist of two parts. Part 1 will assess the safety, tolerability, and efficacy of gocatamig and I-DXd at doses determined in study MK-6070-001 (NCT: NCT04471727). Part 2 will assess the safety and tolerability of gocatamig in participants in Japan and China. Part 3 will assess the safety, tolerability, and efficacy of gocatamig with durvalumab.

Вмешательства

• Биопрепарат Gocatamig
  IV infusion
• Биопрепарат Ifinatamab Deruxtecan (I-DXd)
  IV infusion
• Биопрепарат Durvalumab
  IV infusion

Первичные конечные точки

• Number of Participants Who Experience an Adverse Event (AE) [Срок оценки: Up to approximately 44 months]
• Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) [Срок оценки: Up to approximately 3 weeks]
• Number of Participants Who Discontinue Study Intervention Due to an AE [Срок оценки: Up to approximately 44 months]
• Part 1: Objective Response Rate (ORR) [Срок оценки: Up to approximately 44 months]

Вторичные конечные точки (12)

• Part 1, Part 2 (Arm 5, Arm 6, and Arm 8), and Part 3 (Arm 7): Duration of Response (DOR) [Срок оценки: Up to approximately 44 months]
• Part 1, Part 2 (Arm 6 and Arm 8), and Part 3 (Arm 7): Progression-Free Survival (PFS) [Срок оценки: Up to approximately 44 months]
• Part 2 (Arm 5, Arm 6, and Arm 8) and Part 3 (Arm 7): ORR [Срок оценки: Up to approximately 44 months]
• Maximum Concentration (Cmax) of gocatamig [Срок оценки: At designated timepoints (up to approximately 44 months)]
• Cmax of ifinatamab deruxtecan (I-DXd) [Срок оценки: At designated timepoints (up to approximately 44 months)]
• Cmax of Anti-B7-H3 Antibody [Срок оценки: At designated timepoints (up to approximately 44 months)]
• Cmax of Deruxtecan (DXd) [Срок оценки: At designated timepoints (up to approximately 44 months)]
• Cmax of Durvalumab [Срок оценки: At designated timepoints (up to approximately 44 months)]
• Time to maximum concentration (Tmax) of gocatamig [Срок оценки: At designated timepoints (up to approximately 44 months)]
• Tmax of I-DXd [Срок оценки: At designated timepoints (up to approximately 44 months)]
• Tmax of Anti-B7-H3 Antibody [Срок оценки: At designated timepoints (up to approximately 44 months)]
• Tmax of DXd [Срок оценки: At designated timepoints (up to approximately 44 months)]

Критерии участия

Критерии включения

• Has histologically or cytologically confirmed SCLC that is extensive stage (defined as Stage IV (T any, N any, M1a/b/c) following at least 1 prior line of systemic therapy that included platinum-based chemotherapy
• Must be able to provide archival tumor tissue sample or fresh biopsy tissue sample
• Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)

Критерии исключения

• Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure
• Any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use except for a history of radiation pneumonitis that did not require steroids
• Current history of ILD or clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
• Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
• Active or history of immune deficiency with the exception of HIV-infected participants with well controlled HIV on ART
• History within 6 months before the first dose of study intervention of coronary/peripheral artery bypass graft and/or any coronary/peripheral angioplasty or clinically significant cardiovascular disease such as myocardial infarction, symptomatic congestive heart failure (CHF) (New York Heart Association > class II), and/or uncontrolled cardiac arrhythmia
• History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months before the first dose of study intervention
• Active clinically significant infection requiring systemic therapy
• History of allogeneic tissue/solid organ transplant
• History of leptomeningeal disease
• Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
• Receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of chronic immunosuppressive therapy within 7 days prior to the first dose of study intervention
• Known additional malignancy that is progressing or has required active treatment within the past 3 years
• Untreated or symptomatic brain metastases
• Active viral hepatitis, defined as hepatitis A (hepatitis A virus immunoglobulin M \[IgM\] positive in the setting of associated signs/symptoms), hepatitis B (hepatitis B virus surface antigen \[HbsAg\] positive and/or detectable hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\]), or hepatitis C (hepatitis C virus \[HCV\] antibody positive and detectable HCV ribonucleic acid). Participants with HBV with undetectable viral load after treatment are eligible. Participants with HCV with undetectable virus after treatment are eligible.
• Part 1 only: Radiation therapy to the lung >30 Gy within 6 months before the start of study intervention
• Part 1 only: Abdominal radiation within 4 weeks before start of study intervention
• Part 1 only: Anticancer hormonal treatment (except luteinizing hormone-releasing hormone \[LHRH\]) within 2 weeks before start of study intervention
• Part 1 only: Systemic anticancer therapy (except antibody-based anticancer therapy) or investigational agents within 3 weeks or 5 half-lives, whichever is longer
• Part 1 only: Antibody-based cancer therapy within 3 weeks before start of study intervention
• Part 1 only: Chloroquine/hydroxychloroquine within 2 weeks before start of study intervention
• Part 1 only: Clinically significant corneal disease
• Part 1 only: Has other uncontrolled or significant protocol-specified cardiovascular disease

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 9 центров

• University of Colorado Anschutz Medical Campus ( Site 1110) — Aurora
• University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111) — Miami
• University of Chicago ( Site 1108) — Chicago
• Dana Farber Cancer Institute ( Site 1105) — Boston
• John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103) — Hackensack
• Roswell Park Cancer Institute ( Site 1107) — Buffalo
• Providence Portland Medical Center ( Site 1101) — Portland
• Sarah Cannon Research Institute ( Site 7001) — Nashville
• … и ещё 1 центр

Китай · 7 центров

• Beijing Cancer Hospital ( Site 5401) — Пекин
• Fujian Cancer Hospital ( Site 5413) — Фучжоу
• Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-O — Нанкин
• Shanghai Chest Hospital ( Site 5400) — Шанхай
• Shanghai Pulmonary Hospital ( Site 5405) — Шанхай
• West China Hospital of Sichuan University ( Site 5416) — Чэнду
• The First Affiliated Hospital, Zhejiang University ( Site 5404) — Ханчжоу

Испания · 7 центров

• HOSPITAL CLÍNIC DE BARCELONA ( Site 3310) — Eixample
• Institut Català d'Oncologia - L'Hospitalet ( Site 3317) — L'Hospitalet de Llobregat
• Hospital Clinico San Carlos... ( Site 3316) — Madrid
• Hospital Universitari Vall d'Hebron ( Site 3311) — Barcelona
• Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 3315) — Madrid
• Hospital Universitario HM Sanchinarro ( Site 3313) — Madrid
• Hospital Universitario Virgen de la Victoria ( Site 3312) — Málaga

Израиль · 4 центра

• Rambam Health Care Campus ( Site 3202) — Haifa
• Shaare Zedek Medical Center ( Site 3200) — Jerusalem
• Rabin Medical Center ( Site 3203) — Petah Tikva
• Sheba Medical Center ( Site 3201) — Ramat Gan

Япония · 4 центра

• Aichi Cancer Center ( Site 5000) — Nagoya
• National Cancer Center Hospital East ( Site 5001) — Kashiwa
• Kansai Medical University Hospital ( Site 5004) — Hirakata
• Cancer Institute Hospital of JFCR ( Site 5002) — Koto

Чили · 3 центра

• FALP ( Site 2100) — Santiago
• Pontificia Universidad Catolica de Chile ( Site 2102) — Santiago
• Bradfordhill ( Site 2101) — Santiago

South Korea · 3 центра

• Seoul National University Hospital ( Site 5100) — Seoul
• Severance Hospital, Yonsei University Health System ( Site 5102) — Seoul
• Samsung Medical Center ( Site 5101) — Seoul

Великобритания · 3 центра

• National Institute for Health Research UCLH Clinical Research Facility ( Site 3902) — London
• The Clatterbridge Cancer Centre ( Site 3903) — Liverpool
• The Christie NHS Foundation Trust ( Site 3901) — Manchester

Аргентина · 2 центра

• Hospital Universitario Austral ( Site 2204) — Pilar
• Sanatorio Parque ( Site 2203) — Rosario

Австралия · 2 центра

• Princess Alexandra Hospital ( Site 5300) — Woolloongabba
• Monash Health ( Site 5301) — Clayton

Тайвань · 2 центра

• National Cheng Kung University Hospital ( Site 5202) — Tainan
• Taipei Medical University Hospital ( Site 5201) — Taipei

Turkey (Türkiye) · 2 центра

• Hacettepe Universite Hastaneleri ( Site 3410) — Ankara
• Ankara Bilkent Sehir Hastanesi ( Site 3412) — Ankara

Идентификаторы

NCT: NCT06780137 · 6070-002 · 2024-517926-25-00 · MK-6070-002 · jRCT2031250039

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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