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NCT Number: NCT06780137

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)

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

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Key information

Conditions

Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital Universitario Austral ( Site 2204), Pilar, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Exclusion criteria

  • Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure
  • Any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use except for a history of radiation pneumonitis that did not require steroids
  • Current history of ILD or clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
  • 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

Treatment and study plan

Gocatamig

Biological

IV infusion

Other names: HPN328, MK-6070

Ifinatamab Deruxtecan (I-DXd)

Biological

IV infusion

Other names: DS-7300a, MK-2400

Durvalumab

Biological

IV infusion

Primary outcomes

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

    Time frame: Up to approximately 44 months

    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.

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

    Time frame: Up to approximately 3 weeks

    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.

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

    Time frame: Up to approximately 44 months

    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.

  4. Part 1: Objective Response Rate (ORR)

    Time frame: Up to approximately 44 months

    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.

Secondary outcomes

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

    Time frame: Up to approximately 44 months

    For participants who demonstrate a confirmed 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 RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by the investigator will be presented.

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

    Time frame: Up to approximately 44 months

    PFS is defined as the time from randomization 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 the investigator will be presented.

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

    Time frame: Up to approximately 44 months

    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.

  4. Maximum Concentration (Cmax) of gocatamig

    Time frame: At designated timepoints (up to approximately 44 months)

    Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the drug gocatamig.

  5. Cmax of ifinatamab deruxtecan (I-DXd)

    Time frame: At designated timepoints (up to approximately 44 months)

    Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the drug I-DXd.

  6. Cmax of Anti-B7-H3 Antibody

    Time frame: At designated timepoints (up to approximately 44 months)

    Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the anti-B7-H3 antibody.

  7. Cmax of Deruxtecan (DXd)

    Time frame: At designated timepoints (up to approximately 44 months)

    Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of the drug payload deruxtecan (DXd).

  8. Cmax of Durvalumab

    Time frame: At designated timepoints (up to approximately 44 months)

    Cmax is the maximum concentration of the study drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of durvalumab.

  9. Time to maximum concentration (Tmax) of gocatamig

    Time frame: At designated timepoints (up to approximately 44 months)

    Tmax is the amount of time that a drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the drug gocatamig.

  10. Tmax of I-DXd

    Time frame: At designated timepoints (up to approximately 44 months)

    Tmax is the amount of time that a drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the drug I-DXd.

  11. Tmax of Anti-B7-H3 Antibody

    Time frame: At designated timepoints (up to approximately 44 months)

    Tmax is the amount of time that the drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the anti-B7-H3 antibody.

  12. Tmax of DXd

    Time frame: At designated timepoints (up to approximately 44 months)

    Tmax is the amount of time that the drug is present at the maximum concentration is observed in plasma. Blood samples will be collected to determine the Tmax of the drug payload DXd.

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

    Time frame: At designated timepoints (up to approximately 44 months)

    AUCt is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples will be collected to determine the AUCt of the drug gocatamig.

  14. AUCt of I-DXd

    Time frame: At designated timepoints (up to approximately 44 months)

    AUCt is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples will be collected to determine the AUCt of the drug I-DXd.

  15. AUCt of Anti-B7-H3 Antibody

    Time frame: At designated timepoints (up to approximately 44 months)

    AUCt is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples will be collected to determine the AUCt of the anti-B7-H3 antibody.

  16. AUCt of DXd

    Time frame: At designated timepoints (up to approximately 44 months)

    AUCt is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration. Blood samples will be collected to determine the AUCt of the drug payload Dxd.

  17. Terminal Half-Life (t1/2) of gocatamig

    Time frame: At designated timepoints (up to approximately 44 months)

    t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1/2 of the drug gocatamig.

  18. t1/2 of I-DXd

    Time frame: At designated timepoints (up to approximately 44 months)

    t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1/2 of the drug I-DXd.

  19. t1/2 of Anti-B7-H3 Antibody

    Time frame: At designated timepoints (up to approximately 44 months)

    t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1/2 of the anti-B7-H3 antibody.

  20. t1/2 of DXd

    Time frame: At designated timepoints (up to approximately 44 months)

    t½ is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak. Blood samples will be collected to determine the t1/2 of the drug payload DXd.

  21. Steady State Maximum Concentration (Cmax,ss) of gocatamig

    Time frame: At designated timepoints (up to approximately 44 months)

    Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the drug gocatamig.

  22. Cmax,ss of I-DXd

    Time frame: At designated timepoints (up to approximately 44 months)

    Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the drug I-DXd.

  23. Cmax,ss of Anti-B7-H3 Antibody

    Time frame: At designated timepoints (up to approximately 44 months)

    Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the anti-B7-H3 antibody.

  24. Cmax,ss of DXd

    Time frame: At designated timepoints (up to approximately 44 months)

    Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the drug payload DXd.

  25. Cmax,ss of Durvalumab

    Time frame: At designated timepoints (up to approximately 44 months)

    Cmax,ss is a measure of the maximum level of drug in the blood, measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Cmax,ss of the durvalumab.

  26. Steady State Ctrough (Ctrough,ss) of gocatamig

    Time frame: At designated timepoints (up to approximately 44 months)

    Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the drug gocatamig.

  27. Ctrough,ss of I-DXd

    Time frame: At designated timepoints (up to approximately 44 months)

    Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the drug I-DXd.

  28. Ctrough,ss of Anti-B7-H3 Antibody

    Time frame: At designated timepoints (up to approximately 44 months)

    Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the anti-B7-H3 antibody.

  29. Ctrough,ss of DXd

    Time frame: At designated timepoints (up to approximately 44 months)

    Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of the drug payload DXd.

  30. Ctrough,ss of Durvalumab

    Time frame: At designated timepoints (up to approximately 44 months)

    Ctrough,ss is defined as the trough concentration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Ctrough,ss of durvalumab.

  31. Steady State Time to Maximum Concentration (Tmax,ss) of gocatamig

    Time frame: At designated timepoints (up to approximately 44 months)

    Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the drug gocatamig.

  32. Tmax,ss of I-DXd

    Time frame: At designated timepoints (up to approximately 44 months)

    Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the drug I-DXd.

  33. Tmax,ss of Anti-B7-H3 Antibody

    Time frame: At designated timepoints (up to approximately 44 months)

    Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the anti-B7-H3 antibody.

  34. Tmax,ss of DXd

    Time frame: At designated timepoints (up to approximately 44 months)

    Tmax,ss is the amount of time that a drug is present at the maximum concentration is observed in plasma measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the Tmax,ss of the drug payload DXd.

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

    Time frame: At designated timepoints (up to approximately 44 months)

    AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the drug gocatamig.

  36. AUCt,ss of I-DXd

    Time frame: At designated timepoints (up to approximately 44 months)

    AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the drug I-DXd.

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

    Time frame: At designated timepoints (up to approximately 44 months)

    AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the anti-B7-H3 antibody.

  38. AUCt,ss of DXd

    Time frame: At designated timepoints (up to approximately 44 months)

    AUCt,ss is a measure of plasma drug concentration and time and is estimated as the area under the plot of plasma concentration against time after drug administration measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the AUCt,ss of the drug payload DXd.

  39. Steady state t1/2 (t1/2,ss) of gocatamig

    Time frame: At designated timepoints (up to approximately 44 months)

    t1/2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1/2,ss of the drug gocatamig.

  40. t1/2,ss of I-DXd

    Time frame: At designated timepoints (up to approximately 44 months)

    t1/2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1/2,ss of the drug I-DXd.

  41. t1/2,ss of Anti-B7-H3 Antibody

    Time frame: At designated timepoints (up to approximately 44 months)

    t1/2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1/2,ss of the anti-B7-H3 antibody.

  42. t1/2,ss of DXd

    Time frame: At designated timepoints (up to approximately 44 months)

    t1/2,ss is defined as the time required for plasma drug concentration of study drug to decrease by 50% from peak measured at steady state (time at which the amount of drug eliminated by the body is in equilibrium with the amount taken in). Blood samples will be collected to determine the t1/2,ss of the drug payload DXd.

  43. Accumulation Ratio (AC) of gocatamig

    Time frame: At designated timepoints (up to approximately 44 months)

    Blood samples will be collected to determine the AC of the drug gocatamig.

  44. AC of I-DXd

    Time frame: At designated timepoints (up to approximately 44 months)

    Blood samples will be collected to determine the AC of the drug I-DXd.

  45. AC of Anti-B7-H3 Antibody

    Time frame: At designated timepoints (up to approximately 44 months)

    Blood samples will be collected to determine the AC of the anti-B7-H3 antibody.

  46. AC of DXd

    Time frame: At designated timepoints (up to approximately 44 months)

    Blood samples will be collected to determine the AC of the drug payload DXd.

  47. Incidence of Anti-Drug Antibodies (ADAs) Against gocatamig

    Time frame: At designated timepoints (up to approximately 44 months)

    Blood samples collected at designated timepoints will be used to determine the ADA response to gocatamig. The incidence of ADAs for gocatamig will be presented.

  48. Incidence of ADAs Against I-DXd

    Time frame: At designated timepoints (up to approximately 44 months)

    Blood samples collected at designated timepoints will be used to determine the ADA response to I-DXd. The incidence of ADAs for I-DXd will be presented.

  49. Incidence of ADAs Against Durvalumab

    Time frame: At designated timepoints (up to approximately 44 months)

    Blood samples collected at designated timepoints will be used to determine the ADA response to durvalumab. The incidence of ADAs for durvalumab will be presented.

Study contacts

Contact information is provided by the study sponsor or research team.

Toll Free Number

CONTACT

[email protected]

1-888-577-8839

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Daiichi Sankyo

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jan 17, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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