Clinical Trials List
Protocol NumberMK-6070-002
NCT Number(ClinicalTrials.gov Identfier)NCT06780137
Not yet recruiting
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
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 高冠鈞 Division of Hematology & Oncology
- Shang-Fu Hsu Division of Thoracic Medicine
- Kai-Ling Lee Division of Thoracic Medicine
- Mei-Chuan Chen Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chien-Chung Lin
Co-Principal Investigator
- Shang-Yin Wu Division of Hematology & Oncology
- Po-Lan Su Division of General Internal Medicine
- Chian-Wei Chen Division of General Internal Medicine
- Chun-Hui Lee Division of Hematology & Oncology
- 蔡政軒 Division of General Internal Medicine
- 林建佑 Division of General Internal Medicine
- Seu-Chun Yang Division of General Internal Medicine
- Wu-Chou Su Division of Hematology & Oncology
- 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) Part 1: Evaluation of the safety and tolerability of MK-6070 administered at different time intervals in combination with I-DXd or as monotherapy with I-DXd every 2 weeks
(2) Part 1: Evaluation of the objective response rate (ORR) of MK-6070 administered at different time intervals in combination with I-DXd or as monotherapy with I-DXd every 2 weeks, according to RECIST 1.1.
(3) Part 2: Evaluation of the safety and tolerability of MK-6070 monotherapy
(4) Part 3: Evaluation of the safety and tolerability of MK-6070 in combination with durvalumab
Test Drug
注射劑
Active Ingredient
MK-6070
Dosage Form
270
Dosage
2mg/2mL
Endpoints
(1) Part 1: Evaluation of the safety and tolerability of MK-6070 administered at different time intervals in combination with I-DXd or as monotherapy with I-DXd every 2 weeks.
(2) Part 1: Evaluation of the objective response rate (ORR) of MK-6070 administered at different time intervals in combination with I-DXd or as monotherapy with I-DXd every 2 weeks, according to RECIST 1.1.
(3) Part 2: Evaluation of the safety and tolerability of MK-6070 monotherapy.
(4) Part 3: Evaluation of the safety and tolerability of MK-6070 in combination with durvalumab.
(2) Part 1: Evaluation of the objective response rate (ORR) of MK-6070 administered at different time intervals in combination with I-DXd or as monotherapy with I-DXd every 2 weeks, according to RECIST 1.1.
(3) Part 2: Evaluation of the safety and tolerability of MK-6070 monotherapy.
(4) Part 3: Evaluation of the safety and tolerability of MK-6070 in combination with durvalumab.
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
History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD, and or suspected ILD/pneumonitis
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
Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure
History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD, and or suspected ILD/pneumonitis
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
The Estimated Number of Participants
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Taiwan
5 participants
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Global
242 participants
