RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT06780137Sponsor: Merck Sharp & Dohme LLCLast updated: 2026-04-20

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

Detailed description

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.

Arms & interventions

BiologicalGocatamig
IV infusion
BiologicalIfinatamab Deruxtecan (I-DXd)
IV infusion
BiologicalDurvalumab
IV infusion

Outcome measures

Primary

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to approximately 44 months

Secondary

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
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
Part 2 (Arm 5, Arm 6, and Arm 8) and Part 3 (Arm 7): ORR
Time frame: Up to approximately 44 months
Maximum Concentration (Cmax) of gocatamig
Time frame: At designated timepoints (up to approximately 44 months)
Cmax of ifinatamab deruxtecan (I-DXd)
Time frame: At designated timepoints (up to approximately 44 months)
Cmax of Anti-B7-H3 Antibody
Time frame: At designated timepoints (up to approximately 44 months)
Cmax of Deruxtecan (DXd)
Time frame: At designated timepoints (up to approximately 44 months)
Cmax of Durvalumab
Time frame: At designated timepoints (up to approximately 44 months)
Time to maximum concentration (Tmax) of gocatamig
Time frame: At designated timepoints (up to approximately 44 months)
Tmax of I-DXd
Time frame: At designated timepoints (up to approximately 44 months)
Tmax of Anti-B7-H3 Antibody
Time frame: At designated timepoints (up to approximately 44 months)
Tmax of DXd
Time frame: At designated timepoints (up to approximately 44 months)
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 of I-DXd
Time frame: At designated timepoints (up to approximately 44 months)
AUCt of Anti-B7-H3 Antibody
Time frame: At designated timepoints (up to approximately 44 months)
AUCt of DXd
Time frame: At designated timepoints (up to approximately 44 months)
Terminal Half-Life (t1/2) of gocatamig
Time frame: At designated timepoints (up to approximately 44 months)
t1/2 of I-DXd
Time frame: At designated timepoints (up to approximately 44 months)
t1/2 of Anti-B7-H3 Antibody
Time frame: At designated timepoints (up to approximately 44 months)
t1/2 of DXd
Time frame: At designated timepoints (up to approximately 44 months)
Steady State Maximum Concentration (Cmax,ss) of gocatamig
Time frame: At designated timepoints (up to approximately 44 months)
Cmax,ss of I-DXd
Time frame: At designated timepoints (up to approximately 44 months)
Cmax,ss of Anti-B7-H3 Antibody
Time frame: At designated timepoints (up to approximately 44 months)
Cmax,ss of DXd
Time frame: At designated timepoints (up to approximately 44 months)
Cmax,ss of Durvalumab
Time frame: At designated timepoints (up to approximately 44 months)
Steady State Ctrough (Ctrough,ss) of gocatamig
Time frame: At designated timepoints (up to approximately 44 months)
Ctrough,ss of I-DXd
Time frame: At designated timepoints (up to approximately 44 months)
Ctrough,ss of Anti-B7-H3 Antibody
Time frame: At designated timepoints (up to approximately 44 months)
Ctrough,ss of DXd
Time frame: At designated timepoints (up to approximately 44 months)
Ctrough,ss of Durvalumab
Time frame: At designated timepoints (up to approximately 44 months)
Steady State Time to Maximum Concentration (Tmax,ss) of gocatamig
Time frame: At designated timepoints (up to approximately 44 months)
Tmax,ss of I-DXd
Time frame: At designated timepoints (up to approximately 44 months)
Tmax,ss of Anti-B7-H3 Antibody
Time frame: At designated timepoints (up to approximately 44 months)
Tmax,ss of DXd
Time frame: At designated timepoints (up to approximately 44 months)
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 of I-DXd
Time frame: At designated timepoints (up to approximately 44 months)
AUCt,ss of Anti-B7-H3 Antibody
Time frame: At designated timepoints (up to approximately 44 months)
AUCt,ss of DXd
Time frame: At designated timepoints (up to approximately 44 months)
Steady state t1/2 (t1/2,ss) of gocatamig
Time frame: At designated timepoints (up to approximately 44 months)
t1/2,ss of I-DXd
Time frame: At designated timepoints (up to approximately 44 months)
t1/2,ss of Anti-B7-H3 Antibody
Time frame: At designated timepoints (up to approximately 44 months)
t1/2,ss of DXd
Time frame: At designated timepoints (up to approximately 44 months)
Accumulation Ratio (AC) of gocatamig
Time frame: At designated timepoints (up to approximately 44 months)
AC of I-DXd
Time frame: At designated timepoints (up to approximately 44 months)
AC of Anti-B7-H3 Antibody
Time frame: At designated timepoints (up to approximately 44 months)
AC of DXd
Time frame: At designated timepoints (up to approximately 44 months)
Incidence of Anti-Drug Antibodies (ADAs) Against gocatamig
Time frame: At designated timepoints (up to approximately 44 months)
Incidence of ADAs Against I-DXd
Time frame: At designated timepoints (up to approximately 44 months)
Incidence of ADAs Against Durvalumab
Time frame: At designated timepoints (up to approximately 44 months)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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 * 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 * 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

Study locations (9)

University of Colorado Anschutz Medical Campus ( Site 1110)

Aurora, Colorado, 80045

Recruiting

Study Coordinator · Contact

303-724-6268

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

Miami, Florida, 33136

Recruiting

Study Coordinator · Contact

305-243-1754

University of Chicago ( Site 1108)

Chicago, Illinois, 60637

Recruiting

Study Coordinator · Contact

773-702-6149

Dana Farber Cancer Institute ( Site 1105)

Boston, Massachusetts, 02215

Recruiting

Study Coordinator · Contact

617-632-6049

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

Hackensack, New Jersey, 07601

Recruiting

Study Coordinator · Contact

551-996-5863

Roswell Park Cancer Institute ( Site 1107)

Buffalo, New York, 14263

Recruiting

Study Coordinator · Contact

716-845-3167

Providence Portland Medical Center ( Site 1101)

Portland, Oregon, 97213

Recruiting

Study Coordinator · Contact

503-215-5696

Sarah Cannon Research Institute ( Site 7001)

Nashville, Tennessee, 37203

Recruiting

Study Coordinator · Contact

844-482-4812

Medical College of Wisconsin ( Site 1112)

Milwaukee, Wisconsin, 53226

Recruiting

Study Coordinator · Contact

414-805-8900