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| ID | Type | Description | Link |
|---|---|---|---|
| KEYNOTE-E13 | Other Identifier | MK-3475-E13 Merck Sharp & Dohme LLC. |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Study of NGM831 as Monotherapy and in Combination with Pembrolizumab or Pembrolizumab and NGM438 in Advanced or Metastatic Solid Tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NGM831 Monotherapy Dose Escalation | Experimental | Part 1a Single Agent Dose Escalation |
|
| NGM831 combination dose finding with pembrolizumab (KEYTRUDA®) | Experimental | Part 1b NGM831 plus pembrolizumab (KEYTRUDA®) |
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| NGM831 and NGM438 Combination Dose Finding with pembrolizumab (KEYTRUDA®) | Experimental | Part 1c NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGM831 | Drug | Drug: NGM831 NGM831 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 21 days after the first dose of study treatment. | Baseline up to 21 Days |
| Incidence of Adverse Events | Number of patients with treatment-emergent adverse events (AEs) 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of NGM831 | Cmax is defined as the observed maximum serum concentration post drug administration. Will be measured for Cycle 1 and Cycle 3. | Baseline up to approximately 9 weeks |
| Time to Maximum Observed Serum Concentration (Tmax) of NGM831 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NGM Clinical Study Site | Gilbert | Arizona | 85234 | United States | ||
| NGM Clinical Study Site |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 8, 2026 | |
| Reset | Jul 1, 2026 |
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| NGM831 plus pembrolizumab (KEYTRUDA®) | Drug | Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21day cycle. Multiple dose levels will be evaluated. Drug: pembrolizumab (KEYTRUDA®) pembrolizumab (KEYTRUDA®) will be administered intravenously (IV) every 3 weeks in a 21day cycle. |
|
| NGM831 and NGM438 plus pembrolizumab (KEYTRUDA®) | Drug | Drug: NGM831 NGM831 is given intravenously (IV) every 3 weeks in a 21-day cycle. Multiple dose levels will be evaluated. Drug: NGM438 NGM438 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. |
|
Tmax is defined as the time to reach the observed maximum serum concentration (Cmax) post drug administration. Will be measured for Cycle 1 and Cycle 3. |
| Baseline up to approximately 9 weeks |
| Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM831 | AUC is defined as area under the concentration time curve of the dosing interval post drug administration. Will be calculated for Cycle 1 and Cycle 3. | Baseline up to approximately 9 weeks |
| Maximum Observed Serum Concentration (Cmax) of NGM438 | Cmax is defined as the observed maximum serum concentration post drug administration.Will be measured for Cycle 1 and Cycle 3. | Baseline up to approximately 9 weeks |
| Time to Maximum Observed Serum Concentration (Tmax) of NGM438. | Tmax is defined as the time to reach the observed maximum serum concentration (Cmax) post drug administration. Will be measured for Cycle 1 and Cycle 3. | Baseline up to approximately 9 weeks |
| Area Under the Concentration Time Curve of the dosing interval (AUC) of Serum NGM438 | AUC is defined as area under the concentration time curve of the dosing interval post drug administration. Will be calculated for Cycle 1 and Cycle 3. | Baseline up to approximately 9 weeks |
| Anti-drug Antibodies (ADA) Against NGM831 | Incidence and titers of anti-drug antibodies (ADA) against NGM831. Will be measured on Day 1 of each cycle. | Baseline up to approximately 24 months |
| Anti-drug Antibodies (ADA) Against NGM438 | Incidence and titers of anti-drug antibodies (ADA) against NGM438. Will be measured on Day 1 of each cycle. | Baseline up to approximately 24 months |
| Neutralizing antibodies (nAb) against NGM831 | Incidence and titers of neutralizing antibodies (nAb) against NGM831. Will be measured on Day 1 of each cycle. | Baseline up to approximately 24 months |
| Neutralizing antibodies (nAb) against NGM438 | Incidence and titers of neutralizing antibodies (nAb) against NGM438. Will be measured on Day 1 of each cycle. | Baseline up to approximately 24 months |
| Number of Patients with Objective Responses | Objective Response Rate is defined as the proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) divided by the total number of evaluable patients per RECIST v1.1. | Baseline up to approximately 24 months |
| Los Angeles |
| California |
| 90025 |
| United States |
| NGM Clinical Study Site | Sarasota | Florida | 34232 | United States |
| NGM Clinical Study Site | Tampa | Florida | 33612 | United States |
| NGM Clinical Study Site | Grand Rapids | Michigan | 49546 | United States |
| NGM Clinical Study Site | New York | New York | 10016 | United States |
| NGM Clinical Study Site | Oklahoma City | Oklahoma | 73104 | United States |
| NGM Clinical Study Site | Austin | Texas | 78758 | United States |
| NGM Clinical Study Site | Houston | Texas | 77030 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 8, 2026 | Jul 1, 2026 |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D001943 | Breast Neoplasms |
| D013274 | Stomach Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002583 | Uterine Cervical Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D015179 | Colorectal Neoplasms |
| D004938 | Esophageal Neoplasms |
| D010051 | Ovarian Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D011471 | Prostatic Neoplasms |
| D008545 | Melanoma |
| D008654 | Mesothelioma |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006258 | Head and Neck Neoplasms |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004935 | Esophageal Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D006058 | Gonadal Disorders |
| D000230 | Adenocarcinoma |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D000236 | Adenoma |
| D018301 | Neoplasms, Mesothelial |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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