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)

NCT06780137 | Recruiting Phase 1 FDA Drug

• 4 other identifiers: 6070-0022024-517926-25-00MK-6070-002jRCT2031250039
• Study Type: interventional
• Target: 262
• Locations: 12 countries
• Sites: 48

Brief 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

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (4)

• Number of Participants Who Experience an Adverse Event (AE)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE in the study will be presented.

  Up to approximately 44 months

• Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)

  A DLT is defined as any drug-related adverse event (AE) observed during the DLT evaluation period that meet pre-defined DTL criteria. Toxicities will be graded using National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) version 5.0, or the American Society for Transplant and Cellular Therapy (ASTCT) criteria. The number of participants who experience at least one DLT will be presented.

  Up to approximately 3 weeks

• Number of Participants Who Discontinue Study Intervention Due to an AE

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue the study intervention due to an AE in the study will be presented.

  Up to approximately 44 months

• Part 1: Objective Response Rate (ORR)

  ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.

  Up to approximately 44 months

Secondary Outcomes (49)

• Part 1, Part 2 (Arm 5, Arm 6, and Arm 8), and Part 3 (Arm 7): Duration of Response (DOR)

  Up to approximately 44 months

• Part 1, Part 2 (Arm 6 and Arm 8), and Part 3 (Arm 7): Progression-Free Survival (PFS)

  Up to approximately 44 months

• Part 2 (Arm 5, Arm 6, and Arm 8) and Part 3 (Arm 7): ORR

  Up to approximately 44 months

• Maximum Concentration (Cmax) of gocatamig

  At designated timepoints (up to approximately 44 months)

• Cmax of ifinatamab deruxtecan (I-DXd)

  At designated timepoints (up to approximately 44 months)

Study Arms (9)

Part 1 Arm 1: Gocatamig and I-DXd

EXPERIMENTAL

Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.

Biological: Gocatamig; Biological: Ifinatamab Deruxtecan (I-DXd)

Part 1 Arm 2: Gocatamig and I-DXd

EXPERIMENTAL

Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.

Biological: Gocatamig; Biological: Ifinatamab Deruxtecan (I-DXd)

Part 1 Arm 3a: I-DXd Monotherapy

EXPERIMENTAL

Participants will receive I-DXd until documented disease progression or discontinuation criteria are met.

Biological: Ifinatamab Deruxtecan (I-DXd)

Part 1 Arm 3b: Gocatamig and I-DXd

EXPERIMENTAL

Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.

Biological: Gocatamig; Biological: Ifinatamab Deruxtecan (I-DXd)

Part 2 Arm 4: Gocatamig Monotherapy in Japan

EXPERIMENTAL

Participants in Japan will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met.

Biological: Gocatamig

Part 2 Arm 5: Gocatamig Monotherapy in China

EXPERIMENTAL

Participants in China will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met.

Biological: Gocatamig

Part 2 Arm 6: Gocatamig

EXPERIMENTAL

Participants will receive gocatamig at a determined dose until documented disease progression or discontinuation criteria are met.

Biological: Gocatamig

Part 3 Arm 7: Gocatamig and Durvalumab

EXPERIMENTAL

Participants will receive gocatamig and durvalumab at a determined dose until documented disease progression or discontinuation criteria are met.

Biological: Gocatamig; Biological: Durvalumab

Part 2 Arm 8: Gocatamig (Alternate Presentation)

EXPERIMENTAL

Participants will receive an alternate presentation of gocatamig at a determined dose until documented disease progression or discontinuation criteria are met.

Biological: Gocatamig

Interventions

Gocatamig BIOLOGICAL

IV infusion

Also known as: HPN328, MK-6070

Part 1 Arm 1: Gocatamig and I-DXd; Part 1 Arm 2: Gocatamig and I-DXd; Part 1 Arm 3b: Gocatamig and I-DXd; Part 2 Arm 4: Gocatamig Monotherapy in Japan; Part 2 Arm 5: Gocatamig Monotherapy in China; Part 2 Arm 6: Gocatamig; Part 2 Arm 8: Gocatamig (Alternate Presentation); Part 3 Arm 7: Gocatamig and Durvalumab

Ifinatamab Deruxtecan (I-DXd) BIOLOGICAL

IV infusion

Also known as: DS-7300a, MK-2400

Part 1 Arm 1: Gocatamig and I-DXd; Part 1 Arm 2: Gocatamig and I-DXd; Part 1 Arm 3a: I-DXd Monotherapy; Part 1 Arm 3b: Gocatamig and I-DXd

Durvalumab BIOLOGICAL

IV infusion

Part 3 Arm 7: Gocatamig and Durvalumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure
• History of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use or has current or suspected pneumonitis/ILD that cannot be ruled out by imaging at screening
• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Daiichi Sankyo: collaborator

Study Sites (48)

University of Colorado Anschutz Medical Campus ( Site 1110)

Aurora, Colorado, 80045, United States

RECRUITING

University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111)

Miami, Florida, 33136, United States

RECRUITING

University of Chicago ( Site 1108)

Chicago, Illinois, 60637, United States

RECRUITING

Dana Farber Cancer Institute ( Site 1105)

Boston, Massachusetts, 02215, United States

RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)

Hackensack, New Jersey, 07601, United States

RECRUITING

Roswell Park Cancer Institute ( Site 1107)

Buffalo, New York, 14263, United States

RECRUITING

Providence Portland Medical Center ( Site 1101)

Portland, Oregon, 97213, United States

RECRUITING

Sarah Cannon Research Institute ( Site 7001)

Nashville, Tennessee, 37203, United States

RECRUITING

Medical College of Wisconsin ( Site 1112)

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Hospital Universitario Austral ( Site 2204)

Pilar, Buenos Aires, B1629WWA, Argentina

RECRUITING

Sanatorio Parque ( Site 2203)

Rosario, Santa Fe Province, S2000DSV, Argentina

RECRUITING

Princess Alexandra Hospital ( Site 5300)

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Monash Health ( Site 5301)

Clayton, Victoria, 3168, Australia

RECRUITING

FALP ( Site 2100)

Santiago, Region M. de Santiago, 7500921, Chile

RECRUITING

Pontificia Universidad Catolica de Chile ( Site 2102)

Santiago, Region M. de Santiago, 8330032, Chile

RECRUITING

Bradfordhill ( Site 2101)

Santiago, Region M. de Santiago, 8420383, Chile

RECRUITING

Beijing Cancer Hospital ( Site 5401)

Beijing, Beijing Municipality, 100142, China

RECRUITING

Fujian Cancer Hospital ( Site 5413)

Fuzhou, Fujian, 350014, China

RECRUITING

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( Site 5403)

Nanjing, Jiangsu, 210008, China

RECRUITING

Shanghai Chest Hospital ( Site 5400)

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Shanghai Pulmonary Hospital ( Site 5405)

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

West China Hospital of Sichuan University ( Site 5416)

Chengdu, Sichuan, 610041, China

RECRUITING

The First Affiliated Hospital, Zhejiang University ( Site 5404)

Hangzhou, Zhejiang, 310000, China

RECRUITING

Rambam Health Care Campus ( Site 3202)

Haifa, 3109601, Israel

ACTIVE NOT RECRUITING

Shaare Zedek Medical Center ( Site 3200)

Jerusalem, 9103102, Israel

RECRUITING

Rabin Medical Center ( Site 3203)

Petah Tikva, 4941492, Israel

RECRUITING

Sheba Medical Center ( Site 3201)

Ramat Gan, 5265601, Israel

RECRUITING

Aichi Cancer Center ( Site 5000)

Nagoya, Aichi-ken, 464-8681, Japan

RECRUITING

National Cancer Center Hospital East ( Site 5001)

Kashiwa, Chiba, 277-0882, Japan

RECRUITING

Kansai Medical University Hospital ( Site 5004)

Hirakata, Osaka, 573-1191, Japan

RECRUITING

Cancer Institute Hospital of JFCR ( Site 5002)

Koto, Tokyo, 135-8550, Japan

RECRUITING

Seoul National University Hospital ( Site 5100)

Seoul, 03080, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System ( Site 5102)

Seoul, 03722, South Korea

RECRUITING

Samsung Medical Center ( Site 5101)

Seoul, 06351, South Korea

RECRUITING

HOSPITAL CLÍNIC DE BARCELONA ( Site 3310)

Eixample, Barcelona, 08036, Spain

RECRUITING

Institut Català d'Oncologia - L'Hospitalet ( Site 3317)

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Hospital Clinico San Carlos... ( Site 3316)

Madrid, Madrid, Comunidad de, 28040, Spain

RECRUITING

Hospital Universitari Vall d'Hebron ( Site 3311)

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 3315)

Madrid, 28040, Spain

RECRUITING

Hospital Universitario HM Sanchinarro ( Site 3313)

Madrid, 28050, Spain

RECRUITING

Hospital Universitario Virgen de la Victoria ( Site 3312)

Málaga, 29010, Spain

RECRUITING

National Cheng Kung University Hospital ( Site 5202)

Tainan, 704, Taiwan

RECRUITING

Taipei Medical University Hospital ( Site 5201)

Taipei, 11030, Taiwan

RECRUITING

Hacettepe Universite Hastaneleri ( Site 3410)

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Ankara Bilkent Sehir Hastanesi ( Site 3412)

Ankara, 06800, Turkey (Türkiye)

RECRUITING

National Institute for Health Research UCLH Clinical Research Facility ( Site 3902)

London, London, City of, W1T 7HA, United Kingdom

RECRUITING

The Clatterbridge Cancer Centre ( Site 3903)

Liverpool, L7 8YA, United Kingdom

RECRUITING

The Christie NHS Foundation Trust ( Site 3901)

Manchester, M20 4BX, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

durvalumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 consists of four arms (gocatamig and I-DXd at different dosing intervals). Participants will be randomized to one of the four arms using an interactive response technology (IRT) system. Part 2 consists of four arms (gocatamig monotherapy in participants in Japan, gocatamig monotherapy in participants in China, and gocatamig evaluated at different dosing intervals across two additional study arms). Part 3 consists of a single arm (gocatamig and durvalumab).

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: February 27, 2025
• Primary Completion (Estimated): August 31, 2029
• Study Completion (Estimated): January 17, 2030
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

KR (3); GB (3); CL (3); ES (7); TU (2); US (9); CN (7); TW (2); JP (4); IL (4); AR (2); AU (2)