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Small Cell Lung Cancer Extensive StagePhase 1/2NCT07227597

A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)

A Phase 1/2 study testing Gocatamig, I-DXd and Atezolizumab in people with Small Cell Lung Cancer Extensive Stage, run by Merck Sharp & Dohme LLC at 57 sites in 13 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

Researchers are looking for new ways to treat extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC is a type of lung cancer that has spread throughout the lung, to the other lung, or to other parts of the body. A standard (usual) treatment for ES-SCLC uses both chemotherapy and immunotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer Extensive Stage
What is being tested?
Gocatamig, I-DXd and Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
57 sitesin 13 countries
Study dates
29 Jan 2026to 30 Dec 2030
Phase
Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The main inclusion criteria include but are not limited to the following:
  • Has a histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC)
  • For participants receiving gocatamig + ifinatamab deruxtecan (I-DXd) in maintenance only:
  • Completed 3 to 4 cycles of platinum + etoposide chemotherapy with concurrent approved anti-programmed cell death 1/Ligand 1 (anti PD-1/L1) as first line (1L) treatment of ES-SCLC within 6 weeks prior to enrollment
  • No radiological disease progression per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
  • No other prior systemic ES-SCLC therapy allowed
Show all 11Show fewer
  • Rechallenge therapy counts as an additional line and leads to exclusion
  • For participants receiving gocatamig + I-DXd in induction and maintenance, or gocatamig + I-DXd in induction followed by gocatamig + atezolizumab in maintenance, or carboplatin + etoposide + atezolizumab in induction followed by atezolizumab in maintenance: No prior systemic ES-SCLC treatment allowed
  • Applicable to all participants: prior limited-stage small cell lung cancer (SCLC) is allowed if > 6 months have passed since the end of previous therapy and progression
  • Must be able to provide a pretreatment archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated
  • Measurable disease by RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if growth has been shown in such lesions since the completion of radiation

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • Has pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  • Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, current ILD, ILD that cannot be ruled out by imaging at screening, or suspected ILD
  • Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
  • Has history of clinically significant intracranial bleeding or spinal cord bleeding
  • Has active neurologic paraneoplastic syndrome
Show all 19Show fewer
  • Has history 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), and/or uncontrolled cardiac arrhythmia within 6 months before the first dose of study intervention
  • Has other uncontrolled or significant protocol specified cardiovascular disease
  • Has history of arterial thrombosis within 6 months before the first dose of study intervention
  • Has chronic liver disease
  • Has history of allogeneic tissue/solid organ transplant
  • Has history of leptomeningeal disease
  • Is infected with human immunodeficiency virus (HIV) and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
  • Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
  • Has known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has major surgery within 4 weeks or minor surgery within 2 weeks of allocation/randomization (or first dose), or is anticipated to require a major surgical procedure during the study

Trial locations and contacts

57 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

57 sites in 13 countries

United States13 sites, 13 recruiting

  • University of Colorado, Anschutz Cancer Pavilion ( Site 0125)

    Aurora, Colorado, 80045

    Study Coordinator, 303-724-4304

    Recruiting

  • University of Virginia Health System ( Site 0122)

    Charlottesville, Virginia, 22908

    Study Coordinator, 434-924-4251

    Recruiting

  • Saint Elizabeth Medical Center Edgewood ( Site 0112)

    Edgewood, Kentucky, 41017

    Study Coordinator, 859-301-4000

    Recruiting

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0101)

    Hackensack, New Jersey, 07601

    Study Coordinator, 551-996-5955

    Recruiting

  • Houston Methodist Hospital - Houston Methodist Neal Cancer Center ( Site 0113)

    Houston, Texas, 77030

    Study Coordinator, 646-407-2086

    Recruiting

  • The University of Tennessee Medical Center ( Site 0120)

    Knoxville, Tennessee, 37920

    Study Coordinator, 865-305-8780

    Recruiting

  • Lt. Col. Luke Weathers, Jr. VA Medical Center ( Site 0133)

    Memphis, Tennessee, 38105

    Study Coordinator, 901-351-3673

    Recruiting

  • SCRI Oncology Partners ( Site 7000)

    Nashville, Tennessee, 37203

    Study Coordinator, 844-482-4812

    Recruiting

  • Orlando Health Cancer Institute ( Site 0108)

    Orlando, Florida, 32806

    Study Coordinator, 321-841-1869

    Recruiting

  • Providence Cancer Institute, Franz Clinic - Eastside ( Site 0107)

    Portland, Oregon, 97213

    Study Coordinator, 503-215-5696

    Recruiting

  • Providence Medical Foundation ( Site 0124)

    Santa Rosa, California, 95403

    Study Coordinator, 707-521-3830

    Recruiting

  • Avera Cancer Institute- Research ( Site 0104)

    Sioux Falls, South Dakota, 57105

    Study Coordinator, 605-322-6900

    Recruiting

  • Washington University School of Medicine ( Site 0134)

    St Louis, Missouri, 63110

    Study Coordinator, 314-747-1171

    Recruiting

Other trials in United States

China10 sites, 10 recruiting

  • Beijing Cancer Hospital ( Site 1604)

    Beijing, Beijing Municipality, 100142

    Study Coordinator, 010-88121122

    Recruiting

  • Sichuan Cancer hospital. ( Site 1609)

    Chengdu, Sichuan, 610213

    Study Coordinator, 18180900912

    Recruiting

  • Fujian Provincial Cancer Hospital ( Site 1607)

    Fuzhou, Fujian, 350014

    Study Coordinator, +86059183660063

    Recruiting

  • Southern Medical University Nanfang Hospital ( Site 1608)

    Guangzhou, Guangdong, 510515

    Study Coordinator, +86 13632102245

    Recruiting

  • The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 1602)

    Hangzhou, Zhejiang, 310003

    Study Coordinator, +8657187236560

    Recruiting

  • Harbin Medical University Cancer Hospital ( Site 1606)

    Harbin, Heilongjiang, 150081

    Study Coordinator, 0451-86298000

    Recruiting

  • Jiangmen Central Hospital ( Site 1611)

    Jiangmen, Guangdong, 529000

    Study Coordinator, +86 13702282382

    Recruiting

  • The First Affiliated Hospital of Nanchang University ( Site 1610)

    Nanchang, Jiangxi, 330209

    Study Coordinator, +86079186319453

    Recruiting

  • Shanghai East Hospital ( Site 1600)

    Shanghai, Shanghai Municipality, 200000

    Study Coordinator, 021-20334534

    Recruiting

  • Taizhou Hospital of Zhejiang Province ( Site 1601)

    Taizhou, Zhejiang, 317000

    Study Coordinator, 0576-85199810

    Recruiting

Other trials in China

Greece6 sites, 6 recruiting

  • Errikos Dunant Hospital Center ( Site 0501)

    Athens, Attica, 115 26

    Study Coordinator, +302106972246

    Recruiting

  • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0502)

    Athens, Attica, 115 27

    Study Coordinator, +302107700220

    Recruiting

  • Athens Medical Center ( Site 0504)

    Athens, Attica, 151 25

    Study Coordinator, +302107464642

    Recruiting

  • University General Hospital of Heraklion ( Site 0503)

    Heraklion, Irakleio, 71500

    Study Coordinator, +302810392091

    Recruiting

  • European Interbalkan Medical Center ( Site 0500)

    Thessaloniki, 570 01

    Study Coordinator, +302310400213

    Recruiting

  • European Interbalkan Medical Center ( Site 0505)

    Thessaloniki, 570 01

    Study Coordinator, +302310390671

    Recruiting

Other trials in Greece

South Korea4 sites, 4 recruiting

  • Seoul National University Hospital ( Site 1402)

    Seoul, 03080

    Study Coordinator, 82-2-2072-3559

    Recruiting

  • Severance Hospital Yonsei University Health System ( Site 1403)

    Seoul, 03722

    Study Coordinator, +82215991004

    Recruiting

  • Asan Medical Center ( Site 1404)

    Seoul, 05505

    Study Coordinator, +82230103215

    Recruiting

  • Samsung Medical Center ( Site 1401)

    Seoul, 06351

    Study Coordinator, 02-3410-1795

    Recruiting

Other trials in South Korea

Spain4 sites, 4 recruiting

  • Hospital Universitari Vall d'Hebron ( Site 1001)

    Barcelona, 08035

    Study Coordinator, +34932746000

    Recruiting

  • Hospital Universitario Insular de Gran Canaria ( Site 1002)

    Las Palmas de Gran Canaria, Las Palmas, 35016

    Study Coordinator, +34 928441738

    Recruiting

  • Hospital San Pedro ( Site 1004)

    Logroño, La Rioja, 26006

    Study Coordinator, 941278760

    Recruiting

  • Hospital Universitario Gregorio Maranon ( Site 1003)

    Madrid, 28007

    Study Coordinator, 917996984

    Recruiting

Other trials in Spain

Argentina3 sites, 3 recruiting

  • CEMIC ( Site 1903)

    Caba., Buenos Aires, C1431FWO

    Study Coordinator, +5491160006609

    Recruiting

  • Hospital Austral ( Site 1901)

    Pilar, Buenos Aires, B1629AHJ

    Study Coordinator, +54911 38018573

    Recruiting

  • Sanatorio Parque ( Site 1900)

    Rosario, Santa Fe Province, S2000DSV

    Study Coordinator, +5493416955611

    Recruiting

Other trials in Argentina

Chile3 sites, 3 recruiting

  • Fundación Arturo López Pérez ( Site 0200)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, 56224205098

    Recruiting

  • Pontificia Universidad Catolica de Chile ( Site 0202)

    Santiago, Region M. de Santiago, 8330032

    Study Coordinator, +56934271024

    Recruiting

  • Bradfordhill ( Site 0201)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, 56229490970

    Recruiting

Other trials in Chile

Italy3 sites, 3 recruiting

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0702)

    Meldola, Forli-Cesena, 47014

    Study Coordinator, +39 0543 739100

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0701)

    Milan, 20133

    Study Coordinator, 00390223903665

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0700)

    Roma, 00168

    Study Coordinator, 00390630153446

    Recruiting

Other trials in Italy

Thailand3 sites, 3 recruiting

  • Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 3002)

    Bangkok, Bangkok, 10300

    Study Coordinator, +6622443000

    Recruiting

  • Faculty of Medicine Siriraj Hospital ( Site 3000)

    Bangkoknoi, Bangkok, 10700

    Study Coordinator, +6624194488

    Recruiting

  • Songklanagarind hospital ( Site 3001)

    Hat Yai, Changwat Songkhla, 90110

    Study Coordinator, +6674451469

    Recruiting

Other trials in Thailand

Turkey (Türkiye)3 sites, 3 recruiting

  • Adana City Hospital ( Site 1202)

    Adana, 06200

    Study Coordinator, +905384120982

    Recruiting

  • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1200)

    Ankara, 06100

    Study Coordinator, +905077740811

    Recruiting

  • Abdurrahman Yurtaslan Onkoloji Hastanesi ( Site 1201)

    Ankara, 06200

    Study Coordinator, +905433870086

    Recruiting

Other trials in Turkey (Türkiye)

Germany2 sites, 2 recruiting

  • Universitaetsklinikum Jena ( Site 0403)

    Jena, Thuringia, 07747

    Study Coordinator, +4936419324584

    Recruiting

  • Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne ( Site 0401)

    Tübingen, Baden-Wurttemberg, 72076

    Study Coordinator, +4970712982795

    Recruiting

Other trials in Germany

Israel2 sites, 2 recruiting

  • Rambam Health Care Campus ( Site 0602)

    Haifa, 3109601

    Study Coordinator, +97247772688

    Recruiting

  • Sheba Medical Center ( Site 0601)

    Ramat Gan, 5265601

    Study Coordinator, +97235303030

    Recruiting

Other trials in Israel

Poland1 site, 1 recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0902)

    Warsaw, Masovian Voivodeship, 02-781

    Study Coordinator, +48225463066

    Recruiting

Other trials in Poland

About this study

Official title: A Phase 1b/2 Open-label Study Evaluating Different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-Based Regimens in First-line Extensive Stage Small Cell Lung Cancer

Researchers are looking for new ways to treat extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC is a type of lung cancer that has spread throughout the lung, to the other lung, or to other parts of the body.

A standard (usual) treatment for ES-SCLC uses both chemotherapy and immunotherapy.

Read more
  • Chemotherapy is a treatment that works to destroy cancer cells or stop them from growing.
  • Immunotherapy is a treatment that helps the immune system fight cancer.

Gocatamig and I-DXd (short for ifinatamab deruxtecan) are study medicines. Researchers want to know if giving gocatamig and I-DXd together can treat ES-SCLC. Researchers will also look at giving the study medicines with standard treatment. Gocatamig is a T-cell engager therapy. I-DXd is an antibody drug conjugate.

  • T-cell engager therapy is a certain type of immunotherapy that uses T-cells to find and destroy cancer cells.
  • A T-cell is a type of white blood cell, which are cells that help the body fight infection.
  • An antibody drug conjugate (ADC) is a treatment that attaches to a protein on cancer cells and delivers treatment to destroy those cells.

The goals of this study are to learn:

  • About the safety of combining gocatamig and I-DXd and if people tolerate them together
  • If people who receive gocatamig and I-DXd have ES-SCLC respond, which means the cancer gets smaller or goes away
Read the detailed description

In Part A, participants will be allocated to Arm 1 or Arm 2 per investigator's discretion. In Part B, participants will be allocated to Arm 1 per investigator's discretion and randomized to Arms 2, 3, and 4.

Being tested
Gocatamig, I-DXd, Atezolizumab, Carboplatin, Etoposide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GocatamigDrug

    Also called MK-6070, HPN328, DS-3280

    Intravenous (IV) administration

  • I-DXdDrug

    Also called MK-2400, DS-7300a

    IV administration

  • AtezolizumabDrug

    IV administration

  • CarboplatinDrug

    IV administration

  • EtoposideDrug

    IV administration

  • Rescue MedicationsDrug

    Participants will receive rescue medications at the investigator's discretion. Recommended rescue medications include tocilizumab for treatment of cytokine release syndrome (CRS); dexamethasone, acetaminophen, and diphenhydramine for CRS/infusion-related reaction (IRR) prophylaxis; and 5-hydroxytryptamine 3 (5-HT3) receptor antagonist, neurokinin 1 (NK-1) receptor antagonist, and corticosteroid for prevention of nausea and vomiting.

Study groups in NCT07227597
Study groupRoleWhat they receive
Arm 1, Parts A and B: Gocataming + I-DXdExperimentalParticipants who completed standard of care (SOC) induction chemotherapy with concurrent approved anti-programmed cell death 1/ligand 1 protein (anti-PD-1/L1) treatment for ES-SCLC and did not have disease progression per investigator discretion, will receive gocatamig and I-DXd in the maintenance phase, until documented disease progression or meeting other study discontinuation criteria.
Receives: Drug: Gocatamig; Drug: I-DXd; Drug: Rescue Medications
Arm 2, Parts A and B: Gocataming + I-DXdExperimentalParticipants who did not receive prior systemic treatment for ES-SCLC will receive gocatamig and I-DXd during induction and maintenance phases, until documented disease progression or meeting other study discontinuation criteria.
Receives: Drug: Gocatamig; Drug: I-DXd; Drug: Rescue Medications
Arm 3, Part B: Gocataming + I-DXd → gocatamig + atezolizumabExperimentalParticipants who did not receive prior systemic treatment for ES-SCLC will receive gocatamig and I-DXd in the induction phase, followed by gocatamig and atezolizumab in the maintenance phase, until documented disease progression or meeting other study discontinuation criteria.
Receives: Drug: Gocatamig; Drug: I-DXd; Drug: Atezolizumab; Drug: Rescue Medications
Arm 4, Part B: Carboplatin + etoposide + atezolizumab → atezolizumabActive comparatorParticipants who did not receive prior systemic treatment for ES-SCLC will receive SOC (carboplatin + etoposide + atezolizumab) in the induction phase, followed by atezolizumab in the maintenance phase, until documented disease progression or meeting other study discontinuation criteria.
Receives: Drug: Atezolizumab; Drug: Carboplatin; Drug: Etoposide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Experience an Adverse Event (AE)

    An AE is defined as 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. The number of participants who experience an AE will be reported.

    Measured: Up to approximately 58 months

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

    DLT will be defined as any drug-related AE observed during the DLT evaluation period (up to 21 days) that meets the protocol-specified DLT criteria. The number of participants who experience at least one DLT will be presented.

    Measured: Up to approximately 21 days

  3. Number of Participants Who Discontinue Study Intervention Due to an AE

    An AE is defined as 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. The number of participants who discontinue study intervention due to an AE will be reported.

    Measured: Up to approximately 58 months

  4. 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 Blinded Independent Central Review (BICR) will be presented.

    Measured: Up to approximately 58 months

Secondary outcomes (22)

  1. Disease Control Rate (DCR)

    DCR is defined, per RECIST 1.1, as the percentage of participants who have a CR or PR or Stable Disease (SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD: At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD). The DCR as assessed by BICR will be presented.

    Measured: Up to approximately 58 months

  2. Duration of Response (DOR)

    For participants who demonstrate a confirmed CR or PR per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.

    Measured: Up to approximately 58 months

  3. Progression-Free Survival (PFS)

    PFS is defined as the time from randomization (Part B for Arms 2-4) or from the first dose of study treatment (safety run-in Part A and Arm 1 Part B) to the first documented PD or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.

    Measured: Up to approximately 58 months

  4. Overall Survival (OS)

    OS is defined as the time from the first dose of study treatment (Part A and Arm 1 Part B) or randomization (Part B for Arms 2-4) to death due to any cause.

    Measured: Up to approximately 58 months

  5. Area Under the Concentration-Time Curve Over the Dosing Interval t (AUCt) of Gocatamig

    Blood samples will be collected at multiple time points to determine the AUCt of the drug gocatamig.

    Measured: At designated time points (up to approximately 58 months)

  6. AUCt of I-DXd

    Blood samples will be collected at multiple time points to determine the AUCt of the drug I-DXd.

    Measured: At designated time points (up to approximately 58 months)

  7. AUCt of Deruxtecan (DXd)

    DXd is the payload released from the drug I-DXd. Blood samples will be collected at multiple time points to determine the AUCt of the drug payload DXd.

    Measured: At designated time points (up to approximately 58 months)

  8. AUCt of Anti-B7-H3 Antibody

    Blood samples will be collected at multiple time points to determine the AUCt of the anti-B7-H3 antibody.

    Measured: At designated time points (up to approximately 58 months)

  9. Area Under the Steady-State Concentration-Time Curve Over the Dosing Interval t (AUCt,ss) of Gocatamig

    Blood samples will be collected at multiple time points to determine the AUCt,ss of the drug gocatamig.

    Measured: At designated time points (up to approximately 58 months)

  10. AUCt,ss of I-DXd

    Blood samples will be collected at multiple time points to determine the AUCt,ss of the drug I-DXd.

    Measured: At designated time points (up to approximately 58 months)

  11. AUCt,ss of DXd

    DXd is the payload released from the drug I-DXd. Blood samples will be collected at multiple time points to determine the AUCt,ss of the drug payload DXd.

    Measured: At designated time points (up to approximately 58 months)

  12. AUCt,ss of Anti-B7-H3 Antibody

    Blood samples will be collected at multiple time points to determine the AUCt,ss of the anti-B7-H3 antibody.

    Measured: At designated time points (up to approximately 58 months)

  13. Maximum Concentration (Cmax) of Gocatamig

    Blood samples will be collected at multiple time points to determine Cmax of the drug gocatamig.

    Measured: At designated time points (up to approximately 58 months)

  14. Cmax of I-DXd

    Blood samples will be collected at multiple time points to determine Cmax of the drug I-DXd.

    Measured: At designated time points (up to approximately 58 months)

  15. Cmax of DXd

    DXd is the payload released from the drug I-DXd. Blood samples will be collected at multiple time points to determine Cmax of the drug payload DXd.

    Measured: At designated time points (up to approximately 58 months)

  16. Cmax of Anti-B7-H3 Antibody

    Blood samples will be collected at multiple time points to determine Cmax of the anti-B7-H3 antibody.

    Measured: At designated time points (up to approximately 58 months)

  17. Trough Concentration (Ctrough) of Gocatamig

    Blood samples will be collected at multiple time points to determine Ctrough of the drug gocatamig.

    Measured: At designated time points (up to approximately 58 months)

  18. Ctrough of I-DXd

    Blood samples will be collected at multiple time points to determine Ctrough of the drug I-DXd.

    Measured: At designated time points (up to approximately 58 months)

  19. Ctrough of DXd

    DXd is the payload released from the drug I-DXd. Blood samples will be collected at multiple time points to determine Ctrough of the drug payload DXd.

    Measured: At designated time points (up to approximately 58 months)

  20. Ctrough of Anti-B7-H3 Antibody

    Blood samples will be collected at multiple time points to determine Ctrough of the anti-B7-H3 antibody.

    Measured: At designated time points (up to approximately 58 months)

  21. Incidence of Anti-Drug Antibodies (ADAs) Against Gocatamig

    Blood samples will be collected at multiple time points to determine the ADA response to gocatamig. The incidence of ADAs for gocatamig will be presented.

    Measured: At designated time points (up to approximately 58 months)

  22. Incidence of ADAs Against I-DXd

    Blood samples will be collected at multiple time points to determine the ADA response to I-DXd. The incidence of ADAs for I-DXd will be presented.

    Measured: At designated time points (up to approximately 58 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2025
  2. Study start29 Jan 2026
  3. Primary completion29 Nov 2030 (estimated)
  4. Study completion30 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07227597
Sponsor's protocol ID
6070-003
Other IDs
MK-6070-003, U1111-1318-5025, 2025-521032-11-00, 2025
Status last verified
Oct 2026
First submitted
10 Nov 2025
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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