Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MK-6070, HPN328, DS-3280
Gocatamig · 3 trials · 4 indications
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.
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.
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.
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.
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.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. AEs will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) version 5.0 (American Society for Transplant and Cellular Therapy (ASTCT) grading criteria for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS)). The percentage of participants who experience an AE in the study will be presented.
An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. AEs will be graded according to NCI CTACAE version 5.0 (ASTCT grading criteria for CRS and ICANS). The percentage of participants who discontinue due to an AE in the study will be presented.
A DLT is defined as an AE that represents a clinically significant shift from baseline and must be considered related or suspected to be related to study drug (gocatamig and/or atezolizumab or I-DXd) by the Investigator or Sponsor. AEs will be graded according to NCI CTACAE version 5.0 (ASTCT grading criteria for CRS and ICANS). The number of participants with a DLT will be presented.
Cmax is the maximum concentration of the drug observed in serum. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of gocatamig.
Cmax is the maximum concentration of the drug observed in serum. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of Atezolizumab.
Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax of I-DXd.
Tmax is the amount of time that a drug is present at the maximum concentration observed in serum. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the Tmax of gocatamig.
Tmax is the amount of time that a drug is present at the maximum concentration observed in serum. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the Tmax of atezolizumab.
Tmax is the amount of time that a drug is present at the maximum concentration observed in plasma. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the Tmax of I-DXd.
AUC is a measure of serum drug concentration and time and is estimated as the area under the plot of serum concentration against time after drug administration. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine t (AUCt) of gocatamig.
AUC is a measure of serum drug concentration and time and is estimated as the area under the plot of serum concentration against time after drug administration. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine t (AUCt) of atezolizumab.
AUC 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 collected pre dose and at multiple timepoints post dose will be used to determine t (AUCt) of I-DXd.
AUCinf is a measure of serum drug concentration and time to infinity and is estimated as the area under the plot of serum concentration against time to infinity after drug administration. Blood samples collected at multiple timepoints post-dose will be used to determine the AUCinf of gocatamig.
AUCinf is a measure of serum drug concentration and time to infinity and is estimated as the area under the plot of serum concentration against time to infinity after drug administration. Blood samples collected at multiple timepoints post-dose will be used to determine the AUCinf of atezolizumab.
AUCinf is a measure of plasma drug concentration and time to infinity and is estimated as the area under the plot of plasma concentration against time to infinity after drug administration. Blood samples collected at multiple timepoints post-dose will be used to determine the AUCinf of I-DXd.
t1/2 is a measure of how long it takes to clear 50% of the drug from serum after reaching Cmax. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the t1/2 of gocatamig.
t1/2 is a measure of how long it takes to clear 50% of the drug from serum after reaching Cmax. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the t1/2 of atezolizumab.
t1/2 is a measure of how long it takes to clear 50% of the drug from plasma after reaching Cmax. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the t1/2 of I-DXd.
CL is the apparent total clearance of the drug from serum after oral administration. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine CL of gocatamig.
CL is the apparent total clearance of the drug from serum after oral administration. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine CL of atezolizumab.
CL is the apparent total clearance of the drug from plasma after oral administration. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine CL of I-DXd.
Cmax,ss is the maximum concentration of the drug in serum observed in serum under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax,ss of gocatamig.
Cmax,ss is the maximum concentration of the drug observed in serum under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Css,max of atezolizumab.
Cmax,ss is the maximum concentration of the drug observed in plasma under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Cmax,ss of I-DXd.
Ctrough,ss is the lowest concentration reached by a drug in serum under steady state conditions before the next dose is administered. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Ctrough,ss of gocatamig.
Ctrough,ss is the lowest concentration reached by a drug in serum under steady state conditions before the next dose is administered. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Ctrough,ss of atezolizumab.
Ctrough,ss is the lowest concentration reached by a drug in plasma under steady state conditions before the next dose is administered. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine Ctrough,ss of I-DXd.
Tmax,ss is the amount of time that a drug is present at the maximum concentration observed in serum under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the Tmax,ss of gocatamig.
Tmax,ss is the amount of time that a drug is present at the maximum concentration observed in serum under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the Tmax,ss of atezolizumab.
Tmax,ss is the amount of time that a drug is present at the maximum concentration observed in plasma under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the Tmax,ss of I-DXd.
AUCt,ss is a measure of serum drug concentration and time and is estimated as the area under the plot of serum concentration against time after drug administration under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine AUCt,ss of gocatamig.
AUCt,ss is a measure of serum drug concentration and time and is estimated as the area under the plot of serum concentration against time after drug administration under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine AUCt,ss of atezolizumab.
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 under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine AUCt,ss of I-DXd.
t1/2,ss is a measure of how long it takes to clear 50% of the drug in serum after reaching Cmax under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the t1/2,ss of gocatamig.
t1/2,ss is a measure of how long it takes to clear 50% of the drug after reaching Cmax under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the t1/2,ss of atezolizumab.
t1/2,ss is a measure of how long it takes to clear 50% of the drug in plasma after reaching Cmax under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the t1/2,ss of I-DXd.
CL,ss is the apparent total clearance of the drug from serum after administration under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine CL,ss of gocatamig.
CL,ss is the apparent total clearance of the drug from serum after administration under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine CL,ss of atezolizumab.
CL,ss is the apparent total clearance of the drug from plasma after administration under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine CL,ss of I-DXd.
V,ss is defined as the volume of distribution in serum under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the V,ss of gocatamig.
V,ss is defined as the volume of distribution in serum under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the V,ss of atezolizumab.
V,ss is defined as the volume of distribution in plasma under steady state conditions. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine the V,ss of I-DXd.
AC is the ratio of accumulation of a drug in serum under steady state conditions after repeated administration as compared to a single dose. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine AC of gocatamig.
AC is the ratio of accumulation of a drug in serum under steady state conditions after repeated administration as compared to a single dose. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine AC of atezolizumab.
AC is the ratio of accumulation of a drug in plasma under steady state conditions after repeated administration as compared to a single dose. Blood samples collected pre dose and at multiple timepoints post dose will be used to determine AC of I-DXd.
| Arm | Type | Description |
|---|---|---|
| Arm 1, Parts A and B: Gocataming + I-DXd | EXPERIMENTAL | Participants 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. |
| Arm 2, Parts A and B: Gocataming + I-DXd | EXPERIMENTAL | Participants 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. |
| Arm 3, Part B: Gocataming + I-DXd → gocatamig + atezolizumab | EXPERIMENTAL | Participants 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. |
| Arm 4, Part B: Carboplatin + etoposide + atezolizumab → atezolizumab | ACTIVE_COMPARATOR | Participants 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. |
| Part 1 Arm 1: Gocatamig and I-DXd | EXPERIMENTAL | Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met. |
| Part 1 Arm 2: Gocatamig and I-DXd | EXPERIMENTAL | Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met. |
| Part 1 Arm 3a: I-DXd Monotherapy | EXPERIMENTAL | Participants will receive I-DXd until documented disease progression or discontinuation criteria are met. |
| Part 1 Arm 3b: Gocatamig and I-DXd | EXPERIMENTAL | Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met. |
| Part 2 Arm 4: Gocatamig Monotherapy in Japan | EXPERIMENTAL | Participants in Japan will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met. |
| Part 2 Arm 5: Gocatamig Monotherapy in China | EXPERIMENTAL | Participants in China will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met. |
| Part 2 Arm 6: Gocatamig | EXPERIMENTAL | Participants will receive gocatamig at a determined dose until documented disease progression or discontinuation criteria are met. |
| Part 3 Arm 7: Gocatamig and Durvalumab | EXPERIMENTAL | Participants will receive gocatamig and durvalumab at a determined dose until documented disease progression or discontinuation criteria are met. |
| Part 2 Arm 8: Gocatamig (Alternate Presentation) | EXPERIMENTAL | Participants will receive an alternate presentation of gocatamig at a determined dose until documented disease progression or discontinuation criteria are met. |
| Gocatamig monotherapy dose escalation with 1 week dosing interval | EXPERIMENTAL | Participants will receive gocatamig once weekly (Q1W) via intravenous (IV) infusion during each 21-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation or the Sponsor decides to stop enrollment. |
| Gocatamig monotherapy dose escalation with 2 week dosing interval | EXPERIMENTAL | Participants will receive gocatamig via IV infusion once every 2 weeks (Q2W) of a 28-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment. |
| Gocatamig monotherapy dose escalation with 3 week dosing interval | EXPERIMENTAL | Participants will receive gocatamig via IV infusion once every 3 weeks (Q3W) of a 21-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment. |
| Gocatamig dose escalation with atezolizumab | EXPERIMENTAL | Small cell lung cancer (SCLC) participants will receive gocatamig via IV infusion Q2W during each 28-day cycle and Atezolizumab via IV infusion every 4 weeks (Q4W) on Day 1 of each 28-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment. |
| Gocatamig dose escalation in combination with I-DXd | EXPERIMENTAL | SCLC participants will receive gocatamig via IV infusion Q2W during each 42-day cycle and I-DXd via IV infusion Q3W on Day 1 and Day 22 of each 42-day cycle. Dose escalation may continue until one or more RDEs are identified, participant discontinuation, or the Sponsor decides to stop enrollment. |
| Name | Type | Description |
|---|---|---|
| Gocatamig | DRUG | Intravenous (IV) administration |
| I-DXd | DRUG | IV administration |
| Atezolizumab | DRUG | IV administration |
| Carboplatin | DRUG | IV administration |
| Etoposide | DRUG | IV administration |
| Rescue Medications | DRUG | 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. |
| Ifinatamab Deruxtecan (I-DXd) | BIOLOGICAL | IV infusion |
| Durvalumab | BIOLOGICAL | IV infusion |
Inclusion Criteria: 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: ...
Top 1 of 2 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Amgen Inc. | AMGN | 1 | PHASE3 | Tarlatamab |
Gocatamig is an investigational monoclonal antibody being studied for the treatment of small cell lung cancer, including extensive-stage small cell lung cancer. It is also being evaluated in neuroendocrine carcinoma. It is not yet approved for any indication and remains in clinical development.
Gocatamig is being developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is running the clinical development program for the drug, including trials that combine it with ifinatamab deruxtecan in small cell lung cancer.
Gocatamig is in Phase 1 clinical development. All three of its listed trials are Phase 1 studies, and the program has not advanced beyond that stage. It is investigational and has not been approved by the FDA for any use.
Gocatamig is being studied in three Phase 1 trials: NCT07227597 in extensive-stage small cell lung cancer, NCT06780137 in relapsed or refractory extensive-stage small cell lung cancer, and NCT04471727 in advanced cancers associated with DLL3 expression, including small cell lung cancer and neuroendocrine carcinoma.
Yes, Gocatamig is also known as MK-6070. The two names refer to the same investigational monoclonal antibody developed by Merck, and the clinical trials are listed under the MK-6070 designation, such as MK-6070-002 and MK-6070-003.
The Gocatamig clinical program has a total planned enrollment of 559 participants across its three Phase 1 trials. The trials are controlled, and participants must be at least 18 years old. Two of the trials are currently recruiting, while one is active but no longer recruiting.