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| ID | Type | Description | Link |
|---|---|---|---|
| KEYNOTE-D25 | Other Identifier | Merck Sharp & Dohme Corp | |
| MK-3475-D25 | Other Identifier | Merck Sharp & Dohme Corp |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Study of NGM707 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumor Malignancies
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NGM707 Monotherapy Dose Escalation | Experimental | Part 1a Single Agent Dose Escalation |
|
| NGM707 Combination Dose Finding with pembrolizumab (KEYTRUDA®) | Experimental | Part 1b NGM707 plus pembrolizumab (KEYTRUDA®) |
|
| NGM707 Combination Dose Expansion Arm A | Experimental | NGM707 with pembrolizumab (KEYTRUDA®) in Squamous NSCLC |
|
| NGM707 Combination Dose Expansion Arm B | Experimental | NGM707 with pembrolizumab (KEYTRUDA®) in Non-Squamous NSCLC |
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| NGM707 Combination Dose Expansion Arm C | Experimental | NGM707 with pembrolizumab (KEYTRUDA®) in SCCHN |
|
| NGM707 Monotherapy Dose Expansion Arm D | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGM707 | Drug | Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients with Dose-limiting Toxicities | A DLT is defined as an AE that meets at least one of the criteria listed in protocol, according to National Cancer Institute (NCI) common terminology criteria for AE (CTCAE) version 5.0, and is considered by the investigator to be clinically relevant and attributed to the study treatment during the first 28 days after the first dose of study treatment. | Baseline up to 28 Days |
| Incidence of Adverse Events | Number of patients with adverse events (AEs) according to severity, seriousness, and relationship to study drug An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of patients who experience at least one AE will be presented. | Baseline up to Approximately 24 Months |
| Number of Patients with Clinically Significant Laboratory Abnormalities | Number of patients with clinically significant change from baseline in laboratory abnormalities as characterized by type, frequency, severity (graded by CTCAE version 5.0) and timing. | Baseline up to Approximately 24 Months |
| Number of Patients in Expansion Cohorts with Objective Responses | Objective Response Rate is defined as the proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1 | Baseline up to approximately 24 months |
| Duration of Response for Patients in Expansion Cohorts | Duration of Response is defined as the time from the first documentation of objective response (CR or PR) that is subsequently confirmed per RECIST v1.1, to the time of the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| Observed Plasma Concentration of NGM707 (Including Cmax) | Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycle 4 and each cycle thereafter. | Baseline up to approximately 24 months |
| Area Under the Curve (AUC) of Plasma NGM707 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | NGM Biopharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NGM Clinical Study Site | Los Angeles | California | 90033 | United States | ||
| NGM Clinical Study Site |
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NGM707 in RCC |
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| NGM707 Monotherapy Dose Expansion Arm E | Experimental | NGM707 in CRC |
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| NGM707 Monotherapy Dose Expansion Arm F | Experimental | NGM707 in Ovarian |
|
| NGM707 plus pembrolizumab (KEYTRUDA®) | Drug | Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. Drug: pembrolizumab (KEYTRUDA®) Pembrolizumab (KEYTRUDA®) will be administered intravenously (IV) every 3 weeks in a 21 day cycle. |
|
| NGM707 plus pembrolizumab (KEYTRUDA®) | Drug | Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. Drug: pembrolizumab (KEYTRUDA®) Pembrolizumab (KEYTRUDA®) will be administered intravenously (IV) every 3 weeks in a 21 day cycle. |
|
| NGM707 plus pembrolizumab (KEYTRUDA®) | Drug | Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. Drug: pembrolizumab (KEYTRUDA®) Pembrolizumab (KEYTRUDA®) will be administered intravenously (IV) every 3 weeks in a 21 day cycle. |
|
| NGM707 plus pembrolizumab (KEYTRUDA®) | Drug | Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. Drug: pembrolizumab (KEYTRUDA®) Pembrolizumab (KEYTRUDA®) will be administered intravenously (IV) every 3 weeks in a 21 day cycle. |
|
| NGM707 | Drug | Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. |
|
| NGM707 | Drug | Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. |
|
| NGM707 | Drug | Drug: NGM707 NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated. |
|
| Baseline up to approximately 24 months |
| Progression-free Survival for Patients in Expansion Cohorts | Progression-free survival is defined as the time from start of study treatment to the date of first documentation of objective tumor progression on or following study therapy per RECIST v1.1, or to death due to any cause, whichever comes first. | Baseline up to approximately 24 months |
| Overall Survival for Patients in Combination Dose Expansion Cohorts | Overall survival is defined as the date from start of the study treatment to the date of death due to any cause. | Up to approximately 48 months |
Area under the curve from time zero extrapolated to the last quantifiable dose of NGM707. Time zero extrapolated to the last quantifiable time point prior to the next dose. Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycle 4 and each cycle thereafter. |
| Baseline up to approximately 24 months |
| Plasma Half-life (t1/2) of NGM707 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Will be measured on Day 1, 2, 4, 8 and 15 of Cycles 1 and 3, Day 1 of Cycle 2 and Day 1 of Cycle 4 and each cycle thereafter. | Baseline up to approximately 24 months |
| Anti-drug Antibodies (ADA) Against NGM707 | Incidence and titers of anti-drug antibodies (ADA) against NGM707. Will be measured on Day 1 of each cycle. | Baseline up to approximately 24 months |
| Newport Beach |
| California |
| 92663 |
| United States |
| NGM Clinical Study Site | Santa Monica | California | 90404 | United States |
| NGM Clinical Study Site | Santa Rosa | California | 94505 | United States |
| NGM Clinical Study Site | Lone Tree | Colorado | 80124 | United States |
| NGM Clinical Study Site | Washington D.C. | District of Columbia | 20007 | United States |
| NGM Clinical Study Site | Sarasota | Florida | 34232 | United States |
| NGM Clinical Study Site | Baltimore | Maryland | 21201 | United States |
| NGM Clinical Study Site | Boston | Massachusetts | 02215 | United States |
| NGM Clinical Study Site | Grand Rapids | Michigan | 49546 | United States |
| NGM Clinical Study Site | Omaha | Nebraska | 68130 | United States |
| NGM Clinical Study Site | Albany | New York | 12206 | United States |
| NGM Clinical Study Site | Greenville | South Carolina | 29605 | United States |
| NGM Clinical Study Site | Dallas | Texas | 75246 | United States |
| NGM Clinical Study Site | Dallas | Texas | 78701 | United States |
| NGM Clinical Study Site | Houston | Texas | 77030 | United States |
| NGM Clinical Study Site | San Antonio | Texas | 78229 | United States |
| NGM Clinical Study Site | San Antonio | Texas | 78240 | United States |
| NGM Clinical Study Site | Blacksburg | Virginia | 24060 | United States |
| NGM Clinical Study Site | Vancouver | Washington | 98684 | United States |
| NGM Clinical Study Site | Seoul | 03080 | South Korea |
| NGM Clinical Study Site | Seoul | 05505 | South Korea |
| NGM Clinical Study Site | Seoul | 06351 | South Korea |
| NGM Clinical Study Site | New Taipei City | 235 | Taiwan |
| NGM Clinical Study Site | Taichung | 404327 | Taiwan |
| NGM Clinical Study Site | Tainan | 704 | Taiwan |
| NGM Clinical Study Site | Taipei | 100225 | Taiwan |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D005909 | Glioblastoma |
| D002292 | Carcinoma, Renal Cell |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008545 | Melanoma |
| D013274 | Stomach Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D018281 | Cholangiocarcinoma |
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D015179 | Colorectal Neoplasms |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018358 | Neuroendocrine Tumors |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D006258 | Head and Neck Neoplasms |
| D001941 | Breast Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D005833 | Genital Neoplasms, Female |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004935 | Esophageal Diseases |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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