A PHASE I SINGLE CENTER, OPEN-LABEL, COMBINATION STUDY OF RM-1929 AND PHOTOIMMUNOTHERAPY IN PATIENTS WITH RECURRENT SQUAMOUS CELL HEAD AND NECK CANCER

JRCT ID: jRCT2031200133

Registered date:30/09/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Squamous Cell Carcinoma of Head and Neck
• Date of first enrollment: 26/03/2018
• Target sample size: 3
• Study type: Interventional
• Intervention(s): RM-1929 640 mg/m2 intravenous infusion by drip, followed by light illumination approximately 24 hours later

Outcome(s)

• Primary Outcome: To evaluate the safety of a single treatment of RM-1929 PIT (1 cycle of therapy)
• Secondary Outcome: To evaluate the pharmacokinetic (PK) profile of RM-1929, preliminary efficacy of RM-1929 PIT treatment (i.e., clinical responses evaluated by objective clinical measurement, photographs, biopsies, symptomatic relief and ECOG performance), and Immunogenic response to RM-1929

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients must meet the following criteria to be eligible for study participation:
1. Patients with histologically confirmed recurrent squamous carcinoma of the head and neck, who in the opinion of their treating physician, cannot be satisfactorily treated with surgery, radiation, or platinum chemotherapy and who do not have other options for standard of care treatments.
2. Patients must have received prior systemic platinum-based chemotherapy for treatment of their head and neck cancer, unless in the opinion of the medical oncologist, the use of platinum-based chemotherapy is contraindicated or not recommended, e.g., renal impairment, allergy to platinum compounds, age, liver disease, myelosuppression, neuropathy, hearing loss, etc.
3. Life expectancy > 4 months based on investigator judgement.
4. Male or female patients at least 18 years old; when the subject under 20 years old, informed consent will be obtained from both the subject and his/her legal guardian.
5. Patients must have an ECOG score of 0 - 2.
6. When the subject under 20 years old, informed consent will be obtained from both the subject and his/her legal guardian.

Exclude criteria

Patients with any of the following will be excluded from participation in the study:
1. Patients with a history of significant Erbitux infusion reactions (>=Grade 3).
2. Patients on chemotherapy or Erbitux therapy or radiation therapy within 4 weeks of enrollment.
3. Tumor invading a major blood vessel (such as the carotid artery) unless the vessel has been embolized, stented or surgically ligated to prevent hemorrhage.
4. Tumor is not clearly shown on a CT scan with contrast (MRI with gadolinium if CT not appropriate) or clinically measurable.
5. Location and extension of the tumor precludes effective Photoimmunotherapy (PIT).
6. Patients with impaired hepatic function, ALP (hepatic), AST and/or ALT >3 times the upper limit of normal, and total serum bilirubin >2 mg/dL.
7. Patients with impaired renal function (serum creatinine >2 mg/dL).
8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
9. Patient requires examinations or treatments within 4 weeks after study drug administration where they would be exposed to significant light, e.g., eye examinations, surgical procedures, endoscopy, etc.
10. Unwilling or unable to follow protocol requirements.
11. Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug.

Related Information

• Primary Sponsor: Arron Sarah