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This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving ONM-100 | Experimental | All patients in this arm will receive ONM-100 for injection and undergo intraoperative imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONM-100 | Drug | A polymer micelle covalently conjugated to indocyanine green. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure Mean Fluorescence Intensity of Histologically Confirmed Tumor vs Normal Tissue in Patients Undergoing Routine Surgery [Tumor to Background Ratio (TBR)] | Part 1: Evaluate the dose(s) at which ONM-100 fluorescence imaging is feasible at 3±2 hours post dose. Part 2: Verify the safety and diagnostic performance of ONM-100 compared to standard pathology at the dose(s) and imaging schedule(s) post dose selected from Part 1 for the detection of primary tumors and the metastatic lymph nodes in a variety of solid cancers (which could have included HNSCC, breast cancer, colorectal cancer, urothelial cancer, prostate cancer, ovarian cancer, and/or non-small cell lung carcinoma [NSCLC]). Part 3: Assess the safety and efficacy (sensitivity and positive predictive value [PPV] of ONM-100 for intraoperative imaging during HNSCC surgery. | 1 day |
| Incidence Rate of All Treatment-emergent Adverse Events (TEAEs) From Time of ONM-100 Administration Through Day 28 | Evaluate safety at the dose(s) used to assess imaging feasibility and select the dose(s) and imaging schedule(s) post dose that are safe and provide optimal imaging of solid tumors and metastatic lymph nodes; the dose and time post dose chosen for the detection of primary tumors and metastatic lymph nodes could be the same or different. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Pharmacokinetic Parameters: Cmax | Evaluate the maximum plasma concentration (Cmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging at doses of 1 mg/kg, 2 mg/kg and 3 mg/kg. | 6 days |
| Evaluate Pharmacokinetic Parameters: Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trials@OncoNanoMed.com | OncoNano Medicine, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States | ||
| The University of Texas Southwestern Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1, Cohort A | Patients were administered a single dose of pegsitacianine (ONM-100) at 1 mg/kg and underwent surgery and fluorescence imaging at 3 ±2 hours post dose. |
| FG001 | Part 1, Cohort B |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 3, 2020 | Jan 16, 2023 |
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Evaluate the time to Cmax (Tmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2. |
| 6 days |
| Evaluate Pharmacokinetic Parameters: AUC | Evaluate the Area under the time-concentration curve [AUC] of ONM-100 at 1 mg/kg, 2 mg/kg, and 3 mg/kg doses. | 6 days |
| Evaluate Pharmacokinetic Parameters: CL | Evaluate Total body clearance [CL] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2. | 6 days |
| Evaluate Pharmacokinetic Parameters: Vz | Evaluate the Volume of distribution [Vz] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2. | 6 days |
| Evaluate Pharmacokinetic Parameters: t1/2 | Evaluate the Terminal elimination half-life [t1/2] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2. | 6 days |
| Dallas |
| Texas |
| 75390 |
| United States |
| The University of Texas - M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
Patients were administered a single dose of pegsitacianine (ONM-100) at 3 mg/kg for safety evaluation and surgery and imaging at 3 ±2 hours post dose.
| FG002 | Part 1, Cohort E | Patients were administered a single dose of pegsitacianine (ONM-100) 2 mg/kg and evaluated whether alternate imaging schedules post dose (ie, other than 3 ±2 hours post dose) provided acceptable imaging results at doses ≤3 mg/kg. |
| FG003 | Part 2, Group 2 | Patients were administered a single dose of pegsitacianine (ONM-100) at 3 mg/kg. Surgery/imaging time hours to be determined (TBD). |
| FG004 | Part 2, Group 3 | Patients were administered a single dose of pegsitacianine (ONM-100) at 1.0 mg/kg. Surgery/imaging time, hours 16-80. |
| FG005 | Part 3 | Patients received a single dose of pegsitacianine (ONM-100) at 1 mg/kg administered at 24 ±8 hours prior to surgery. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1, Cohort A | Patients were administered a single dose of pegsitacianine (ONM-100) at 1.0 mg/kg and underwent surgery and fluorescence imaging at 3 ±2 hours post dose. |
| BG001 | Part 1, Cohort B | Patients were administered a single dose of pegsitacianine (ONM-100) at 3.0 mg/kg and underwent surgery and fluorescence imaging at 3 ±2 hours post dose. |
| BG002 | Part 1, Cohort E | Patients were administered a single dose of pegsitacianine (ONM-100) at 2 mg/kg and underwent surgery and fluorescence imaging at 6 ±3 hours post dose. |
| BG003 | Part 2, Group 2 | Patients were administered a single dose of pegsitacianine (ONM-100) at 3 mg/kg and underwent surgery and fluorescence imaging at a time to be determined post dose. |
| BG004 | Part 2, Group 3 | Patients were administered a single dose of pegsitacianine (ONM-100) at 1 mg/kg and underwent surgery and fluorescence imaging at 16-80 hours post dose. |
| BG005 | Part 3 | Patients were administered a single dose of pegsitacianine (ONM-100) at 1 mg/kg and underwent surgery and fluorescence imaging at 24 ±8 hours post dose. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Patients receiving pegsitacianine (ONM-100) | Count of Participants | Participants |
|
| 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 | Measure Mean Fluorescence Intensity of Histologically Confirmed Tumor vs Normal Tissue in Patients Undergoing Routine Surgery [Tumor to Background Ratio (TBR)] | Part 1: Evaluate the dose(s) at which ONM-100 fluorescence imaging is feasible at 3±2 hours post dose. Part 2: Verify the safety and diagnostic performance of ONM-100 compared to standard pathology at the dose(s) and imaging schedule(s) post dose selected from Part 1 for the detection of primary tumors and the metastatic lymph nodes in a variety of solid cancers (which could have included HNSCC, breast cancer, colorectal cancer, urothelial cancer, prostate cancer, ovarian cancer, and/or non-small cell lung carcinoma [NSCLC]). Part 3: Assess the safety and efficacy (sensitivity and positive predictive value [PPV] of ONM-100 for intraoperative imaging during HNSCC surgery. | Posted | Mean | Standard Deviation | ratio | 1 day |
|
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| Primary | Incidence Rate of All Treatment-emergent Adverse Events (TEAEs) From Time of ONM-100 Administration Through Day 28 | Evaluate safety at the dose(s) used to assess imaging feasibility and select the dose(s) and imaging schedule(s) post dose that are safe and provide optimal imaging of solid tumors and metastatic lymph nodes; the dose and time post dose chosen for the detection of primary tumors and metastatic lymph nodes could be the same or different. | Posted | Count of Participants | Participants | 28 days |
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| Secondary | Evaluate Pharmacokinetic Parameters: Cmax | Evaluate the maximum plasma concentration (Cmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging at doses of 1 mg/kg, 2 mg/kg and 3 mg/kg. | The PK analysis population is comprised 19 patients for whom concentration data were available. Due to sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients. | Posted | Geometric Mean | Geometric Coefficient of Variation | μg/mL | 6 days |
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| Secondary | Evaluate Pharmacokinetic Parameters: Tmax | Evaluate the time to Cmax (Tmax) of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2. | The PK analysis population comprised 19 patients for whom concentration data were available. Due to sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients. | Posted | Median | Full Range | hr | 6 days |
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| Secondary | Evaluate Pharmacokinetic Parameters: AUC | Evaluate the Area under the time-concentration curve [AUC] of ONM-100 at 1 mg/kg, 2 mg/kg, and 3 mg/kg doses. | The PK analysis population comprised 19 patients for whom concentration data were available. Due to sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr x μg/mL | 6 days |
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| Secondary | Evaluate Pharmacokinetic Parameters: CL | Evaluate Total body clearance [CL] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2. | The PK analysis population comprised 19 patients for whom concentration data were available. Due to the sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients. | Posted | Geometric Mean | Geometric Coefficient of Variation | L/hr | 6 days |
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| Secondary | Evaluate Pharmacokinetic Parameters: Vz | Evaluate the Volume of distribution [Vz] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2. | The PK analysis population comprised 19 patients for whom concentration data were available. Due to sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients. | Posted | Geometric Mean | Geometric Coefficient of Variation | L | 6 days |
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| Secondary | Evaluate Pharmacokinetic Parameters: t1/2 | Evaluate the Terminal elimination half-life [t1/2] of ONM-100 at the dose(s) and imaging schedule(s) post dose used to assess optimal imaging in Part 1 and Part 2. | The PK analysis population comprised 19 patients for whom concentration data were available. Due to the sparse plasma concentrations for the majority of patients, with the exception of Cmax and Tmax, it was not possible to estimate all parameters for all patients. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr | 6 days |
|
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The total collection period for each subject was approximately one month.
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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 | Part 1, Cohort A | ONM-100 at dose of 1 mg/kg. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG001 | Part 1, Cohort B | ONM-100 at dose of 3 mg/kg. | 0 | 3 | 2 | 3 | 3 | 3 |
| EG002 | Part 1, Cohort E | ONM-100 at dose of 2 mg/kg. | 0 | 3 | 0 | 3 | 2 | 3 |
| EG003 | Part 2, Group 2 | ONM-100 at dose of 3 mg/kg. | 0 | 4 | 1 | 4 | 4 | 4 |
| EG004 | Part 2, Group 3 | ONM-100 at dose of 1 mg/kg. | 0 | 6 | 0 | 6 | 4 | 6 |
| EG005 | Part 3 | ONM-100 at dose of 1 mg/kg. | 0 | 11 | 3 | 11 | 9 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Abscess neck | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Tonsillar hemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Superficial vein thrombosis | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion-related reaction | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Buttock injury | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Neck injury | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Oral pain | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Injection site reaction | General disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Pain | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Nervous system disorders | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dizziness | General disorders | MedDRA (19.0) | Non-systematic Assessment |
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| Headache | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sensory disturbance | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Clinical Operations | OncoNano Medicine, Inc. | 682-285-1411 | clinicaltrials@onconanomed.com |
| Prot_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D015179 | Colorectal Neoplasms |
| D011471 | Prostatic Neoplasms |
| D010051 | Ovarian Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue 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 |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D005833 | Genital Neoplasms, Female |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG004 | Part 2, Group 3 | Patients were administered a single IV infusion of ONM-100 at a dose of 1 mg/kg. |
| OG005 | Part 3 | Patients were administered a single IV infusion of ONM-100 at a dose of 1 mg/kg. |
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