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)

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Oct 8, 2022

Keywords

ClinConnect Summary

The ILLUMINATE Study is a clinical trial that is examining a new imaging agent called Pegsitacianine. This agent helps doctors see cancer more clearly during surgery, especially in patients with head and neck cancer that does not have a known primary site, meaning where the cancer started is unclear. The trial aims to find out how well Pegsitacianine works in identifying cancerous tissues and to ensure it is safe for patients.

To participate in this trial, patients need to be at least 18 years old, have a confirmed diagnosis of head and neck cancer, and meet certain health criteria. This includes having acceptable blood and organ function. Participants will receive a single dose of Pegsitacianine during their surgery. They should expect to follow specific guidelines, such as abstaining from alcohol before and during the study, and using contraception if they are of childbearing potential. This trial is currently recruiting participants, and it aims to improve how doctors detect cancer during surgeries, which could lead to better treatment outcomes.

Gender

ALL

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