A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer, in Patients With Unknown Primary Head and Neck Cancer (ILLUMINATE STUDY)

Trial Title: A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer, in Patients With Unknown Primary Head and Neck Cancer (ILLUMINATE STUDY)

NCT ID: NCT05576974

Condition: Head and Neck Cancer
Unknown Primary Cancer
Head and Neck Squamous Cell Carcinoma

Conditions: Official terms:
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Unknown Primary

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Intervention model description: In Part 1 the single dose of 1 mg/kg of pegsitacianine given 6-100 hours prior to surgery will be used to image primary tumors in patients with HNSCC to evaluated to verify the diagnostic performance of pegsitacianine fluorescence imaging for detecting primary tumors and metastatic lymph nodes. In Part 2, pegsitacianine the single dose of 1 mg/kg of given 6-100 hours prior to surgery will be used to in patients with unknown primary cancer of the head and neck. These patients typically undergo exam under anesthesia with a laryngoscopy as well as panendoscopy for identifying the source of the metastatic cancer found in the cervical nodes. Subjects for Part 2 may begin dosing at any time during Part 1 thus the two parts can run concurrently.

Primary purpose: Diagnostic

Masking: None (Open Label)

Masking description: Open Label

Intervention:

Intervention type: Drug
Intervention name: Pegsitacianine
Description: Infusion of the Pegsitacianine-Intraoperative fluorescence imaging
Arm group label: Part 1 - Cohort A
Arm group label: Part 2 - Cohort B

Summary: This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent.

Detailed description: This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent. The main purpose of this study is to investigate whether Pegsitacianine can be used to image head and neck cancers as well as unknown primary cancer of the head and neck 6-100 hours post dose in patients undergoing routine surgery for biopsy, evaluation, detection or removal of their primary cancer. The study consists of two Parts. - Part 1 will be performed in a single dose of 1 mg/kg given such that Pegsitacianine fluorescence can be used to image primary tumors in patients with HNSCC undergoing routine surgery at 6-100 hours, and if needed at an alternate imaging schedule post dose. - Part 2 will be performed in a single dose of 1 mg/kg given such that Pegsitacianine fluorescence can be used to image primary tumors in patients with unknown primary cancer of the head and neck (UPC) at 6-100 hours, and if needed at an alternate imaging schedule post dose.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Adults ≥18 years of age 2. Biopsy-confirmed diagnosis, for primary or recurrent disease (or high clinical suspicion in the opinion of the Investigator) 1. Part 1: Stage 1 to 4 HNSCC 2. Part 2: UPC squamous cell carcinoma of the head and neck with metastatic disease to at least a single cervical node, AND no biopsy proven evidence of the primary cancer's location. 3. Acceptable hematologic status (as standard surgery protocol requires, as determined by the Investigator), kidney function and liver function. Elevations of creatinine, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or total bilirubin >1.5× the upper limit of normal [ULN] must be determined to be not clinically significant by the Investigator and approved by the Medical Monitor. 4. Documented negative serum pregnancy test for women of childbearing potential (i.e., premenopausal women with intact reproductive organs and women <2 years after menopause) 5. Male patients and female patients of child-bearing potential (i.e., premenopausal women with intact reproductive organs and women <2 years after menopause) must agree to and comply with using medically acceptable contraception including surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal ligation), intrauterine device, oral contraceptive, contraceptive patch, long acting injectable contraceptive, partner's vasectomy, double-barrier method (condom or diaphragm plus spermicide or condom plus diaphragm), or abstinence during the trial and for 6 months thereafter 6. Agree to abstain from alcohol consumption from 72 hours before Pegsitacianine administration through completion of Study Day 10 (±48 hours) visit in Part 1 and Part 2. 7. Adequate potential for follow up Exclusion Criteria: 1. Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible. 2. Life expectancy <12 weeks 3. Karnofsky Performance Status <70% 4. Hepatic impairment (Child-Pugh score >5) or significant liver disease including active hepatitis or cirrhosis 5. Lab values or any sign, symptom, or medical condition that in the opinion of the PI would prevent surgical resection 6. Medical or psychiatric conditions that compromise the patient's ability to give informed consent. 7. Pregnant or lactating women 8. Receiving or planned to receive, during the duration of the study, concomitant medication with a high chance of hepatotoxicity, as judged by the PI based on standard protocols within the study center 9. Alcohol consumption within 72 hours before Pegsitacianine administration 10. Received an investigational agent within the shorter of 5 half-lives or 30 days before Pegsitacianine dosing 11. Inability to adhere to the schedule of assessments or any circumstance that would interfere with the validity of assessments performed in the study 12. The PI considers that the patient should not participate in the study

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Locations:

Facility:
Name: University of Texas Southwestern Medical Center

Address:
City: Dallas
Zip: 75390
Country: United States

Status: Recruiting

Contact:

Phone: 214-648-8096
Email: OTOresearch@utsouthwestern.edu

Contact backup:

Phone: 2146488096
Email: Sindhunikhila.voorugonda@utsouthwestern.edu

Investigator:
Last name: Baran Sumer, MD
Email: Principal Investigator

Start date: April 17, 2024

Completion date: December 31, 2027

Lead sponsor:
Agency: University of Texas Southwestern Medical Center
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: University of Texas Southwestern Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05576974
https://ctep.cancer.gov/protocoldevelopment/
https://www.who.int/publications/journals/bulletin/
https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2
http://www.fda.gov/downloads/drugs/guidances/ucm070107.Pdf
https://www.cfsanappsexternal.fda.gov/scripts/fdcc/index.cfm?set=FoodSubstances