Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| KEYNOTE-E20 | Other Identifier | Merck Sharp & Dohme LLC | |
| MK-3475-E20 | Other Identifier | Merck Sharp & Dohme LLC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Study of NGM438 as Monotherapy and in Combination with Pembrolizumab in Advanced or Metastatic Solid Tumors
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NGM438 Monotherapy Dose Escalation | Experimental | Part 1a Single Agent Dose Escalation |
|
| NGM438 Combination Dose Finding with pembrolizumab ( KEYTRUDA ® ) | Experimental | Part 1b NGM438 plus pembrolizumab ( KEYTRUDA ® ) |
|
| Biopsy Cohort with NGM438 Monotherapy Followed by Combination Therapy with Pembrolizumab(KEYTRUDA ®) | Experimental | Part 1C NGM438 followed by NGM438 plus pembrolizumab ( KEYTRUDA ® ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NGM438 | Drug | NGM438 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 |
| Number of Patients with 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 patient, 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. | 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. | Approximately 24 months |
| Changes in potential pharmacodynamic biomarker CD163 in paired tumor tissue in Patients in the Biopsy Cohort Summary of baseline, post baseline and changes from baseline in CD163 | Baseline up to 15 days | |
| Changes in potential pharmacodynamic biomarker MMP9 in paired tumor tissue in Patients in the Biopsy Cohort Summary of baseline, post baseline and changes from baseline in MMP9 | Baseline up to 15 days | |
| Changes in potential pharmacodynamic biomarker CD8 in paired tumor tissue in Patients in the Biopsy Cohort Summary of baseline, post baseline and changes from baseline in CD8 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of NGM438 | Cmax is defined as the observed maximum serum concentration post drug administration. 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 Cycles 4-6 and every third cycle thereafter | Approximately 24 months. Each Cycle is 21 days. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
• Prior treatment targeting LAIR1
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SCRI Denver | Denver | Colorado | 80218 | United States | ||
| Yale Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pembrolizumab (KEYTRUDA ®) | Drug | Pembrolizumab (KEYTRUDA®) will be administered intravenously (IV) every 3 weeks in a 21 day cycle. |
|
| Baseline up to 15 days |
| Area Under the Curve (AUC) of Serum NGM438 |
Area under the curve from time zero extrapolated to the last 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 Cycles 4-6 and every third cycle thereafter |
| Approximately 24 months. Each Cycle is 21 days. |
| Time to Maximum (Tmax) Observed Serum Concentration of NGM438 | Tmax is defined as the time to reach the observed maximum serum concentration (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 Cycles 4-6 and every third cycle thereafter | Approximately 24 months. Each Cycle is 21 days. |
| Half-life (t1/2) of NGM438 in Serum | Time measured for the serum concentration to decrease by one half during the terminal phase. 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 Cycles 4-6 and every third cycle thereafter | Approximately 24 months. Each Cycle is 21 days. |
| Systemic Clearance (CL) of NGM438 | CL is defined as systemic clearance. 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 Cycles 4-6 and every third cycle thereafter | Approximately 24 months. Each Cycle is 21 days. |
| Volume of Distribution (Vss) of NGM438 at Steady State | Vss is defined as the volume of distribution at steady state. 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 Cycles 4-6 and every third cycle thereafter | Approximately 24 months. Each Cycle is 21 days. |
| 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 through Cycle 6 and every third cycle thereafter. | Approximately 24 months. Each Cycle is 21 days. |
| Number of Patients in Dose Escalation and Dose Finding 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) divided by the total number of evaluable patients per RECIST v1.1 | Approximately 24 months |
| Trough Concentrations of NGM438 in Patients in the Biopsy Cohort | Trough Concentration refers to the serum concentration of NGM438 observed just before treatment administration. 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. | Approximately 24 months. Each Cycle is 21 days. |
| New Haven |
| Connecticut |
| 06520 |
| United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| START Midwest | Grand Rapids | Michigan | 49546 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| MD Anderson | Houston | Texas | 77030 | United States |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
Not provided
Not provided
Not provided