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| ID | Type | Description | Link |
|---|---|---|---|
| CP21-0901 | Other Identifier | ImClone Systems | |
| I5D-IE-JRCA | Other Identifier | Eli Lilly and Company |
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A dose escalation study to determine the maximum tolerated dose of IMC-RON8 in participants with solid tumors. Participants can either be dosed once a week, or once every other week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMC-RON8 | Experimental | A monoclonal antibody to human macrophage-stimulating 1-receptor-8 (RON8). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMC-RON8 | Biological | 5 milligrams per kilogram (mg/kg) intravenously (IV) Once a week for each 4-week treatment cycle, for a total of four doses per cycle. The initial 4-week treatment cycle will be followed by a 2-week observation period. Cohort 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of IMC-RON8 | The MTD was the previous dose level to that in which 2 of 6 participants experienced dose-limiting toxicities (DLTs). DLTs were defined as any of the following events: Grade 4 neutropenia lasting >7 days; any Grade 3 or 4 neutropenia complicated by fever ≥38.5 degrees Celsius or infection, Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by hemorrhage; Grade 3 hepatic toxicity; or any Grade 3 or 4 nonhematologic toxicity (excluding alopecia, fatigue, anorexia, nausea, and vomiting that is controlled with antiemetics). | Baseline through end of study treatment (up to 48 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of IMC-RON8 | The Cmax of IMC-RON8 following the first and multiple IV infusions (the fourth infusion for the qw treatment regimen and the fifth infusion for the q2w treatment regimen) is reported. PK samples were collected per protocol and individual sampling times varied depending on the treatment arm and infusion (first or multiple). The geometric mean and geometric coefficient of variation (%CV) were calculated for treatment arms that had ≥3 participants who had evaluable PK samples for Cmax. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Died | The number of participants who died is reported by cause of death. | Baseline through study completion (up to 52 weeks) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Indianapolis | Indiana | 46202 |
In this dose escalation study, a completed participant was either a participant who completed the initial 4-week treatment cycle (and 2-weeks of observation for specified treatment arms) or one who discontinued therapy, during the same time period, for a narnatumab (IMC-RON8)-related toxicity.
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| ID | Title | Description |
|---|---|---|
| FG000 | IMC-RON8 (5 mg/kg qw) | IMC-RON8: 5 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. |
| FG001 | IMC-RON8 (10 mg/kg qw) | IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. |
| FG002 | IMC-RON8 (15 mg/kg qw) | IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. |
| FG003 | IMC-RON8 (20 mg/kg qw) | IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. Participants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met |
| FG004 | IMC-RON8 (15 mg/kg q2w) | IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle. Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met |
| FG005 | IMC-RON8 (20 mg/kg q2w) | IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle. Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. |
| FG006 | IMC-RON8 (30 mg/kg q2w) | IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle. Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. |
| FG007 | IMC-RON8 (40 mg/kg q2w) | IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle. Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All Participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | IMC-RON8 (5 mg/kg qw) | IMC-RON8: 5 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of IMC-RON8 | The MTD was the previous dose level to that in which 2 of 6 participants experienced dose-limiting toxicities (DLTs). DLTs were defined as any of the following events: Grade 4 neutropenia lasting >7 days; any Grade 3 or 4 neutropenia complicated by fever ≥38.5 degrees Celsius or infection, Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by hemorrhage; Grade 3 hepatic toxicity; or any Grade 3 or 4 nonhematologic toxicity (excluding alopecia, fatigue, anorexia, nausea, and vomiting that is controlled with antiemetics). | Participants who received at least 1 dose of study drug. | Posted | Number | mg/kg | Baseline through end of study treatment (up to 48 weeks) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IMC-RON8 (5 mg/kg qw) | IMC-RON8: 5 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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|
| IMC-RON8 | Biological | 10 mg/kg IV Once a week for each 4-week treatment cycle, for a total of four doses per cycle. The initial 4-week treatment cycle will be followed by a 2-week observation period. Cohort 2 |
|
|
| IMC-RON8 | Biological | 15 mg/kg IV Once a week for each 4-week treatment cycle, for a total of four doses per cycle. The initial 4-week treatment cycle will be followed by a 2-week observation period. Cohort 3 |
|
|
| IMC-RON8 | Biological | 15 mg/kg IV Once every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle. Cohort 4 |
|
|
| IMC-RON8 | Biological | 20 mg/kg IV Once every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle. Cohort 5 |
|
|
| IMC-RON8 | Biological | 25 or 30 mg/kg IV Once every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle. Cohort 6 |
|
|
| IMC-RON8 | Biological | 30, 35, or 40 mg/kg IV Once every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle. Cohort 7 |
|
|
| IMC-RON8 | Biological | 20 or 25 mg/kg IV Once every week for each 4-week treatment cycle, for a total of four doses per cycle. Cohort 8 |
|
|
| First and fourth or fifth infusion: Predose, immediately postdose through 168 or 336 hours postdose |
| PK: Area Under the Curve (AUC) of IMC-RON8 | The AUC from time 0 to the last quantifiable concentration [AUC(0-tlast)] of IMC-RON8 following the first IV infusion is reported along with the AUC for 1 dosing interval (AUC tau). Tau = fourth infusion through 168 hours post infusion for the qw regimen and the fifth infusion through 336 hours post infusion for the q2w regimen. PK samples were collected per protocol and individual sampling times varied depending on the treatment arm and infusion (first or multiple). The geometric mean and geometric coefficient of variation (%CV) were calculated for treatment arms that had ≥3 participants who had evaluable PK samples for AUC(0-tlast) or AUC tau. | First and fourth or fifth infusion: Predose, immediately postdose through 168 or 336 hours postdose |
| Immunogenicity of IMC-RON8 | An immunogenicity assay for IMC-RON8 was not developed due to the decision to not further develop IMC-RON8 based on preliminary results of this study. | Prior to first infusion through study completion (up to 52 weeks) |
| Pharmacodynamics: H-Score of Macrophage-Stimulating 1-Receptor-8 (RON8) | The expression of RON8 was measured in cell membrane/cytoplasm by immunohistochemistry (IHC) methods that incorporated both intensity and distribution of staining. The H-Score was calculated by summing the percentage of cell staining at each intensity multiplied by the weighted intensity of staining: 0 (no staining), 1+ (weak staining), 2+ (medium staining), 3+ (strongest staining). H-Scores could range from a minimum score of 0 to a maximum score of 300; the maximum score indicated the strongest expression. Pharmacodynamic samples were collected per protocol and individual sampling times varied depending on the treatment group. | Prior to first infusion through 1 hour post last infusion (end of study treatment, up to 48 weeks) |
| Best Overall Tumor Response (Antitumor Activity of IMC-RON8 in the Treatment of Solid Tumors) | Response was defined using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST, v 1.1) criteria. CR was the disappearance of all target and nontarget lesions; and any pathological lymph node (whether target or nontarget) must have had a reduction in short axis to <10 millimeters (mm) and normalization of tumor marker level of nontarget lesions. The disappearance of any intratumoral arterial enhancement in all target lesions was also required. PR was having at least a 30% decrease in sum of longest diameter of target lesions. PD was having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir and the unequivocal progression of existing nontarget lesions. SD was small changes that did not meet the above criteria. | Baseline to measured PD (up to 48 weeks) |
| United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | Detroit | Michigan | 48201 | United States |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician | New York | New York | 10065 | United States |
| BG001 | IMC-RON8 (10 mg/kg qw) | IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. |
| BG002 | IMC-RON8 (15 mg/kg qw) | IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. |
| BG003 | IMC-RON8 (15 mg/kg q2w) | IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle. Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. |
| BG004 | IMC-RON8 (20 mg/kg q2w | IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle. Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. |
| BG005 | IMC-RON8 (30 mg/kg q2w) | IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle. Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. |
| BG006 | IMC-RON8 (40 mg/kg q2w) | IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle. Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. |
| BG007 | IMC-RON8 (20 mg/kg qw) | IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. Participants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
|
|
| Secondary | Pharmacokinetics (PK): Maximum Concentration (Cmax) of IMC-RON8 | The Cmax of IMC-RON8 following the first and multiple IV infusions (the fourth infusion for the qw treatment regimen and the fifth infusion for the q2w treatment regimen) is reported. PK samples were collected per protocol and individual sampling times varied depending on the treatment arm and infusion (first or multiple). The geometric mean and geometric coefficient of variation (%CV) were calculated for treatment arms that had ≥3 participants who had evaluable PK samples for Cmax. | Participants who received a first and/or fourth or fifth dose of study drug and had evaluable PK samples for Cmax. No participant was analyzed for the geometric mean (%CV) of Cmax after multiple infusions in the 15, 20, 30, and 40 q2w treatment arms. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (mcg/mL) | First and fourth or fifth infusion: Predose, immediately postdose through 168 or 336 hours postdose |
|
|
|
| Secondary | PK: Area Under the Curve (AUC) of IMC-RON8 | The AUC from time 0 to the last quantifiable concentration [AUC(0-tlast)] of IMC-RON8 following the first IV infusion is reported along with the AUC for 1 dosing interval (AUC tau). Tau = fourth infusion through 168 hours post infusion for the qw regimen and the fifth infusion through 336 hours post infusion for the q2w regimen. PK samples were collected per protocol and individual sampling times varied depending on the treatment arm and infusion (first or multiple). The geometric mean and geometric coefficient of variation (%CV) were calculated for treatment arms that had ≥3 participants who had evaluable PK samples for AUC(0-tlast) or AUC tau. | Participants who received a first and/or fourth or fifth dose of study drug and had evaluable PK samples for AUC(0-tlast) or AUC tau. No participant was analyzed for the geometric mean (%CV) of AUC tau in the 15, 20, 30, and 40 q2w treatment arms. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms*hour/milliliter (mcg*h/mL) | First and fourth or fifth infusion: Predose, immediately postdose through 168 or 336 hours postdose |
|
|
|
| Secondary | Immunogenicity of IMC-RON8 | An immunogenicity assay for IMC-RON8 was not developed due to the decision to not further develop IMC-RON8 based on preliminary results of this study. | Zero participants analyzed. Immunogenicity data were not collected. | Posted | Prior to first infusion through study completion (up to 52 weeks) |
|
|
| Secondary | Pharmacodynamics: H-Score of Macrophage-Stimulating 1-Receptor-8 (RON8) | The expression of RON8 was measured in cell membrane/cytoplasm by immunohistochemistry (IHC) methods that incorporated both intensity and distribution of staining. The H-Score was calculated by summing the percentage of cell staining at each intensity multiplied by the weighted intensity of staining: 0 (no staining), 1+ (weak staining), 2+ (medium staining), 3+ (strongest staining). H-Scores could range from a minimum score of 0 to a maximum score of 300; the maximum score indicated the strongest expression. Pharmacodynamic samples were collected per protocol and individual sampling times varied depending on the treatment group. | Participants who received at least 1 dose of study drug and had tumor tissue samples. | Posted | Median | Full Range | units on a scale | Prior to first infusion through 1 hour post last infusion (end of study treatment, up to 48 weeks) |
|
|
|
| Secondary | Best Overall Tumor Response (Antitumor Activity of IMC-RON8 in the Treatment of Solid Tumors) | Response was defined using Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST, v 1.1) criteria. CR was the disappearance of all target and nontarget lesions; and any pathological lymph node (whether target or nontarget) must have had a reduction in short axis to <10 millimeters (mm) and normalization of tumor marker level of nontarget lesions. The disappearance of any intratumoral arterial enhancement in all target lesions was also required. PR was having at least a 30% decrease in sum of longest diameter of target lesions. PD was having at least 20% increase in sum of longest diameter of target lesions and minimum 5 mm increase above nadir and the unequivocal progression of existing nontarget lesions. SD was small changes that did not meet the above criteria. | Participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Baseline to measured PD (up to 48 weeks) |
|
|
|
| Other Pre-specified | Number of Participants Who Died | The number of participants who died is reported by cause of death. | Participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | Baseline through study completion (up to 52 weeks) |
|
|
|
| 3 |
| 7 |
| 6 |
| 7 |
| EG001 | IMC-RON8 (10 mg/kg qw) | IMC-RON8: 10 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. | 1 | 3 | 3 | 3 |
| EG002 | IMC-RON8 (15 mg/kg qw) | IMC-RON8: 15 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. The initial 4-week treatment cycle was followed by a 2-week observation period. Following the first 6-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. | 0 | 3 | 3 | 3 |
| EG003 | IMC-RON8 (20 mg/kg qw) | IMC-RON8: 20 mg/kg IMC-RON8 administered IV qw for a total of 4 doses per cycle. Participants continued treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. | 6 | 13 | 11 | 13 |
| EG004 | IMC-RON8 (15 mg/kg q2w) | IMC-RON8: 15 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle. Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. | 2 | 4 | 4 | 4 |
| EG005 | IMC-RON8 (20 mg/kg q2w) | IMC-RON8: 20 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle. Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. | 2 | 3 | 3 | 3 |
| EG006 | IMC-RON8 (30 mg/kg q2w) | IMC-RON8: 30 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle. Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. | 1 | 3 | 3 | 3 |
| EG007 | IMC-RON8 (40 mg/kg q2w) | IMC-RON8: 40 mg/kg IMC-RON8 administered IV q2w for a total of 2 doses per cycle. Following the first 8-week tumor assessment, participants who responded to treatment (CR, PR, or SD) could continue treatment (same dose and frequency with no rest period) until PD, toxicity, or other withdrawal criteria were met. | 1 | 3 | 3 | 3 |
| Cardiac failure acute | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Duodenal stenosis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hospitalisation | Surgical and medical procedures | MedDRA 14.1 | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 14.1 | Systematic Assessment |
|
| Otorrhoea | Ear and labyrinth disorders | MedDRA 14.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 14.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Gastrointestinal hypomotility | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Application site reaction | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Catheter site related reaction | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Infusion related reaction | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Mucosal inflammation | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Suprapubic pain | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Bile duct obstruction | Hepatobiliary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Candidiasis | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Furuncle | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 14.1 | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 14.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Bile output abnormal | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood amylase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA 14.1 | Systematic Assessment |
|
| Cachexia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Fluid overload | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 14.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Tumour associated fever | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
|
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cervical cord compression | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypogeusia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Post-traumatic headache | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 14.1 | Systematic Assessment |
|
| Bladder spasm | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 14.1 | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 14.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 14.1 | Systematic Assessment |
|
Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
|
| Multiple infusions |
|
|
|
| AUC tau |
|
|
| PD |
|
| Unknown |
|
| Death, Cause Unknown |
|