Gocatamig
DrugIntravenous (IV) administration
Other names: MK-6070, HPN328, DS-3280
NCT Number: NCT07227597
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.
* 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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
CEMIC ( Site 1903), Caba., Buenos Aires, Argentina
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The main inclusion criteria include but are not limited to the following:
Exclusion criteria
The main exclusion criteria include but are not limited to the following:
Intravenous (IV) administration
Other names: MK-6070, HPN328, DS-3280
IV administration
Other names: MK-2400, DS-7300a
IV administration
IV administration
IV administration
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.
Time frame: Up to approximately 58 months
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.
Time frame: Up to approximately 21 days
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.
Time frame: Up to approximately 58 months
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.
Time frame: Up to approximately 58 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 Blinded Independent Central Review (BICR) will be presented.
Time frame: Up to approximately 58 months
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.
Time frame: Up to approximately 58 months
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.
Time frame: Up to approximately 58 months
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.
Time frame: Up to approximately 58 months
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.
Time frame: At designated time points (up to approximately 58 months)
Blood samples will be collected at multiple time points to determine the AUCt of the drug gocatamig.
Time frame: At designated time points (up to approximately 58 months)
Blood samples will be collected at multiple time points to determine the AUCt of the drug I-DXd.
Time frame: At designated time points (up to approximately 58 months)
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.
Time frame: At designated time points (up to approximately 58 months)
Blood samples will be collected at multiple time points to determine the AUCt of the anti-B7-H3 antibody.
Time frame: At designated time points (up to approximately 58 months)
Blood samples will be collected at multiple time points to determine the AUCt,ss of the drug gocatamig.
Time frame: At designated time points (up to approximately 58 months)
Blood samples will be collected at multiple time points to determine the AUCt,ss of the drug I-DXd.
Time frame: At designated time points (up to approximately 58 months)
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.
Time frame: At designated time points (up to approximately 58 months)
Blood samples will be collected at multiple time points to determine the AUCt,ss of the anti-B7-H3 antibody.
Time frame: At designated time points (up to approximately 58 months)
Blood samples will be collected at multiple time points to determine Cmax of the drug gocatamig.
Time frame: At designated time points (up to approximately 58 months)
Blood samples will be collected at multiple time points to determine Cmax of the drug I-DXd.
Time frame: At designated time points (up to approximately 58 months)
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.
Time frame: At designated time points (up to approximately 58 months)
Blood samples will be collected at multiple time points to determine Cmax of the anti-B7-H3 antibody.
Time frame: At designated time points (up to approximately 58 months)
Blood samples will be collected at multiple time points to determine Ctrough of the drug gocatamig.
Time frame: At designated time points (up to approximately 58 months)
Blood samples will be collected at multiple time points to determine Ctrough of the drug I-DXd.
Time frame: At designated time points (up to approximately 58 months)
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.
Time frame: At designated time points (up to approximately 58 months)
Blood samples will be collected at multiple time points to determine Ctrough of the anti-B7-H3 antibody.
Time frame: At designated time points (up to approximately 58 months)
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.
Time frame: At designated time points (up to approximately 58 months)
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.
Contact information is provided by the study sponsor or research team.
Merck Sharp & Dohme LLC
Industry
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
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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