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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
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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Colorado Anschutz Medical Campus ( Site 1110)
Aurora, Colorado, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111)
Miami, Florida, United States
University of Chicago ( Site 1108)
Chicago, Illinois, United States
Dana Farber Cancer Institute ( Site 1105)
Boston, Massachusetts, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)
Hackensack, New Jersey, United States
Roswell Park Cancer Institute ( Site 1107)
Buffalo, New York, United States
Providence Portland Medical Center ( Site 1101)
Portland, Oregon, United States
Sarah Cannon Research Institute ( Site 7001)
Nashville, Tennessee, United States
Medical College of Wisconsin ( Site 1112)
Milwaukee, Wisconsin, United States
Hospital Universitario Austral ( Site 2204)
Pilar, Buenos Aires, Argentina
Start Date
February 27, 2025
Primary Completion Date
August 31, 2029
Completion Date
January 17, 2030
Last Updated
March 16, 2026
262
ESTIMATED participants
Gocatamig
BIOLOGICAL
Ifinatamab Deruxtecan (I-DXd)
BIOLOGICAL
Durvalumab
BIOLOGICAL
Lead Sponsor
Merck Sharp & Dohme LLC
Collaborators
NCT06066138
NCT05692635
Data Source & Attribution
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