Clinical Trials List
Protocol NumberMK-6070-002
NCT Number(ClinicalTrials.gov Identfier)NCT06780137
Active
2025-10-09 - 2033-12-31
Phase I/II
Recruiting2
ICD-10C34.90
Malignant neoplasm of unspecified part of unspecified bronchus or lung
ICD-10C34.91
Malignant neoplasm of unspecified part of right bronchus or lung
ICD-10C34.92
Malignant neoplasm of unspecified part of left bronchus or lung
ICD-10C7A.090
Malignant carcinoid tumor of the bronchus and lung
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
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
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/08/13
Investigators and Locations
Co-Principal Investigator
- Shang-Fu Hsu Division of Thoracic Medicine
- 高冠鈞 Division of Hematology & Oncology
- Mei-Chuan Chen Division of Thoracic Medicine
- Kai-Ling Lee Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chien-Chung Lin
Co-Principal Investigator
- Seu-Chun Yang Division of General Internal Medicine
- 蔡政軒 Division of General Internal Medicine
- Chian-Wei Chen Division of General Internal Medicine
- Shang-Yin Wu Division of Hematology & Oncology
- Wu-Chou Su Division of Hematology & Oncology
- 林建佑 Division of General Internal Medicine
- Chun-Hui Lee Division of Hematology & Oncology
- Po-Lan Su Division of General Internal Medicine
- Chin-Wei Kuo Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Small Cell Lung Cancer
Objectives
(1)第1部分：評估以不同時程施用MK-6070併用I-DXd或每2週施用I-DXd單一療法的安全性與耐受性
(2)第1部分：根據實體腫瘤反應評估標準第1.1版（RECIST 1.1），評估以不同時程施用MK-6070併用I-DXd或每2週施用I-DXd單一療法的客觀反應率（ORR）
(3)第2部分：評估MK-6070單一療法的安全性與耐受性
(4)第3部分：評估MK-6070併用durvalumab的安全性與耐受性
Test Drug
注射劑
注射劑
注射劑
Active Ingredient
MK-6070
Dosage Form
270
270
270
Dosage
2mg/2mL
12mg/4.8ml
12mg/4.8ml
Endpoints
(1) 第1部分：評估以不同時程施用MK-6070併用I-DXd或每2週施用I-DXd單一療法的安全性與耐受性
(2)第1部分：根據實體腫瘤反應評估標準第1.1版（RECIST 1.1），評估以不同時程施用MK-6070併用I-DXd或每2週施用I-DXd單一療法的客觀反應率（ORR）
(3)第2部分：評估MK-6070單一療法的安全性與耐受性
(4)第3部分：評估MK-6070併用durvalumab的安全性與耐受性
(2)第1部分：根據實體腫瘤反應評估標準第1.1版（RECIST 1.1），評估以不同時程施用MK-6070併用I-DXd或每2週施用I-DXd單一療法的客觀反應率（ORR）
(3)第2部分：評估MK-6070單一療法的安全性與耐受性
(4)第3部分：評估MK-6070併用durvalumab的安全性與耐受性
Inclution Criteria
Inclusion Criteria:
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)
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)
Exclusion Criteria
Exclusion Criteria:
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
Ages Eligible for Study
18 Years and older (Adult, Older Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
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
Ages Eligible for Study
18 Years and older (Adult, Older Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
The Estimated Number of Participants
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Taiwan
11 participants
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Global
242 participants
