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

Status: Recruiting
Location: See all (28) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
Florida
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111)
RECRUITING
Miami
Illinois
University of Chicago ( Site 1108)
RECRUITING
Chicago
Massachusetts
Dana Farber Cancer Institute ( Site 1105)
RECRUITING
Boston
New Jersey
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)
RECRUITING
Hackensack
New York
Roswell Park Cancer Institute ( Site 1107)
RECRUITING
Buffalo
Oregon
Providence Portland Medical Center ( Site 1101)
RECRUITING
Portland
Tennessee
Sarah Cannon Research Institute ( Site 7001)
RECRUITING
Nashville
Other Locations
Australia
Princess Alexandra Hospital ( Site 5300)
RECRUITING
Wooloongabba
Chile
Bradfordhill ( Site 2101)
RECRUITING
Santiago
FALP ( Site 2100)
RECRUITING
Santiago
Israel
Rambam Health Care Campus ( Site 3202)
RECRUITING
Haifa
Shaare Zedek Medical Center ( Site 3200)
RECRUITING
Jerusalem
Sheba Medical Center ( Site 3201)
RECRUITING
Ramat Gan
Japan
Kansai Medical University Hospital ( Site 5004)
RECRUITING
Hirakata
National Cancer Center Hospital East ( Site 5001)
RECRUITING
Kashiwa
Cancer Institute Hospital of JFCR ( Site 5002)
RECRUITING
Koto
Aichi Cancer Center ( Site 5000)
RECRUITING
Nagoya
Republic of Korea
Samsung Medical Center ( Site 5101)
RECRUITING
Seoul
Seoul National University Hospital ( Site 5100)
RECRUITING
Seoul
Spain
Hospital Universitari Vall d'Hebron ( Site 3311)
RECRUITING
Barcelona
HOSPITAL CLÍNIC DE BARCELONA ( Site 3310)
RECRUITING
Eixample
Institut Català d'Oncologia - L'Hospitalet ( Site 3317)
RECRUITING
L'hospitalet De Llobregat
Hospital Clinico San Carlos... ( Site 3316)
RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 3315)
RECRUITING
Madrid
Hospital Universitario HM Sanchinarro ( Site 3313)
RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria ( Site 3312)
RECRUITING
Málaga
Turkey
Ankara Bilkent Sehir Hastanesi ( Site 3412)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri ( Site 3410)
RECRUITING
Ankara
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-02-27
Estimated Completion Date: 2029-08-31
Participants
Target number of participants: 242
Treatments
Experimental: Part 1 Arm 1: Gocatamig and I-DXd
Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.
Experimental: Part 1 Arm 2: Gocatamig and I-DXd
Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.
Experimental: Part 1 Arm 3a: I-DXd Monotherapy
Participants will receive I-DXd until documented disease progression or discontinuation criteria are met.
Experimental: Part 1 Arm 3b: Gocatamig and I-DXd
Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.
Experimental: Part 2 Arm 4: Gocatamig Monotherapy in Japan
Participants in Japan will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met.
Experimental: Part 2 Arm 5: Gocatamig Monotherapy in China
Participants in China will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met.
Experimental: Part 2 Arm 6: Gocatamig
Participants will receive gocatamig at a determined dose until documented disease progression or discontinuation criteria are met.
Experimental: Part 3 Arm 7: Gocatamig and Durvalumab
Participants will receive gocatamig and durvalumab at a determined dose until documented disease progression or discontinuation criteria are met.
Sponsors
Collaborators: Daiichi Sankyo
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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