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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
242
IV infusion
IV infusion
IV infusion
University of Colorado Anschutz Medical Campus ( Site 1110)
Aurora, Colorado, United States
RECRUITINGUniversity of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111)
Miami, Florida, United States
RECRUITINGUniversity of Chicago ( Site 1108)
Chicago, Illinois, United States
RECRUITINGDana Farber Cancer Institute ( Site 1105)
Boston, Massachusetts, United States
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
Part 1, Part 2 (Arm 5 and Arm 6), and Part 3 (Arm 7): Duration of Response (DOR)
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.
Time frame: Up to approximately 44 months
Part 1, Part 2 (Arm 6), and Part 3 (Arm 7): Progression-Free Survival (PFS)
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.
Time frame: Up to approximately 44 months
Part 2 (Arm 5 and Arm 6) and Part 3 (Arm 7): 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
Maximum Concentration (Cmax) of gocatamig
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.
Time frame: At designated timepoints (up to approximately 44 months)
Cmax of ifinatamab deruxtecan (I-DXd)
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John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)
Hackensack, New Jersey, United States
RECRUITINGRoswell Park Cancer Institute ( Site 1107)
Buffalo, New York, United States
RECRUITINGProvidence Portland Medical Center ( Site 1101)
Portland, Oregon, United States
RECRUITINGSarah Cannon Research Institute ( Site 7001)
Nashville, Tennessee, United States
RECRUITINGMEDICAL COLLEGE OF WISCONSIN ( Site 1112)
Milwaukee, Wisconsin, United States
RECRUITINGPrincess Alexandra Hospital ( Site 5300)
Wooloongabba, Queensland, Australia
RECRUITING...and 29 more locations
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.
Time frame: At designated timepoints (up to approximately 44 months)
Cmax of Anti-B7-H3 Antibody
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.
Time frame: At designated timepoints (up to approximately 44 months)
Cmax of Deruxtecan (DXd)
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).
Time frame: At designated timepoints (up to approximately 44 months)
Cmax of Durvalumab
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.
Time frame: At designated timepoints (up to approximately 44 months)
Time to maximum concentration (Tmax) of gocatamig
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.
Time frame: At designated timepoints (up to approximately 44 months)
Tmax of I-DXd
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.
Time frame: At designated timepoints (up to approximately 44 months)
Tmax of Anti-B7-H3 Antibody
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.
Time frame: At designated timepoints (up to approximately 44 months)
Tmax of DXd
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.
Time frame: At designated timepoints (up to approximately 44 months)
Area Under the Concentration-Time Curve Over the Dosing Interval t (AUCt) of gocatamig
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.
Time frame: At designated timepoints (up to approximately 44 months)
AUCt of I-DXd
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.
Time frame: At designated timepoints (up to approximately 44 months)
AUCt of Anti-B7-H3 Antibody
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.
Time frame: At designated timepoints (up to approximately 44 months)
AUCt of DXd
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.
Time frame: At designated timepoints (up to approximately 44 months)
Terminal Half-Life (t1/2) of gocatamig
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.
Time frame: At designated timepoints (up to approximately 44 months)
t1/2 of I-DXd
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.
Time frame: At designated timepoints (up to approximately 44 months)
t1/2 of Anti-B7-H3 Antibody
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.
Time frame: At designated timepoints (up to approximately 44 months)
t1/2 of DXd
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.
Time frame: At designated timepoints (up to approximately 44 months)
Steady State Maximum Concentration (Cmax,ss) of gocatamig
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.
Time frame: At designated timepoints (up to approximately 44 months)
Cmax,ss of I-DXd
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.
Time frame: At designated timepoints (up to approximately 44 months)
Cmax,ss of Anti-B7-H3 Antibody
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.
Time frame: At designated timepoints (up to approximately 44 months)
Cmax,ss of DXd
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.
Time frame: At designated timepoints (up to approximately 44 months)
Cmax,ss of Durvalumab
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.
Time frame: At designated timepoints (up to approximately 44 months)
Steady State Ctrough (Ctrough,ss) of gocatamig
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.
Time frame: At designated timepoints (up to approximately 44 months)
Ctrough,ss of I-DXd
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.
Time frame: At designated timepoints (up to approximately 44 months)
Ctrough,ss of Anti-B7-H3 Antibody
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.
Time frame: At designated timepoints (up to approximately 44 months)
Ctrough,ss of DXd
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.
Time frame: At designated timepoints (up to approximately 44 months)
Ctrough,ss of Durvalumab
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.
Time frame: At designated timepoints (up to approximately 44 months)
Steady State Time to Maximum Concentration (Tmax,ss) of gocatamig
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.
Time frame: At designated timepoints (up to approximately 44 months)
Tmax,ss of I-DXd
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.
Time frame: At designated timepoints (up to approximately 44 months)
Tmax,ss of Anti-B7-H3 Antibody
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.
Time frame: At designated timepoints (up to approximately 44 months)
Tmax,ss of DXd
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.
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
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.
Time frame: At designated timepoints (up to approximately 44 months)
AUCt,ss of I-DXd
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.
Time frame: At designated timepoints (up to approximately 44 months)
AUCt,ss of Anti-B7-H3 Antibody
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.
Time frame: At designated timepoints (up to approximately 44 months)
AUCt,ss of DXd
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.
Time frame: At designated timepoints (up to approximately 44 months)
Steady state t1/2 (t1/2,ss) of gocatamig
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.
Time frame: At designated timepoints (up to approximately 44 months)
t1/2,ss of I-DXd
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.
Time frame: At designated timepoints (up to approximately 44 months)
t1/2,ss of Anti-B7-H3 Antibody
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.
Time frame: At designated timepoints (up to approximately 44 months)
t1/2,ss of DXd
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.
Time frame: At designated timepoints (up to approximately 44 months)
Accumulation Ratio (AC) of gocatamig
Blood samples will be collected to determine the AC of the drug gocatamig.
Time frame: At designated timepoints (up to approximately 44 months)
AC of I-DXd
Blood samples will be collected to determine the AC of the drug I-DXd.
Time frame: At designated timepoints (up to approximately 44 months)
AC of Anti-B7-H3 Antibody
Blood samples will be collected to determine the AC of the anti-B7-H3 antibody.
Time frame: At designated timepoints (up to approximately 44 months)
AC of DXd
Blood samples will be collected to determine the AC of the drug payload DXd.
Time frame: At designated timepoints (up to approximately 44 months)
Incidence of Anti-Drug Antibodies (ADAs) Against gocatamig
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.
Time frame: At designated timepoints (up to approximately 44 months)
Incidence of ADAs Against I-DXd
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.
Time frame: At designated timepoints (up to approximately 44 months)
Incidence of ADAs Against Durvalumab
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.
Time frame: At designated timepoints (up to approximately 44 months)