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Photoimmunotherapy

RM-1995 for Head and Neck Squamous Cell Carcinoma

Phase 1
Waitlist Available
Research Sponsored by Rakuten Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Summary

This trial tests a new treatment for advanced skin and head and neck cancers that haven't responded to other treatments. The treatment uses a special drug activated by red light to target and kill cancer cells. It can be used alone or with another cancer drug called pembrolizumab, which helps the immune system fight cancer.

Eligible Conditions
  • Head and Neck Squamous Cell Carcinoma
  • Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1a Monotherapy: Evaluate the safety and tolerability of RM-1995 PIT treatment, and determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD).
Phase 1b Combination Therapy: Evaluate the safety and tolerability of RM-1995 PIT treatment in combination with pembrolizumab and determine the MTD or MAD.
Secondary study objectives
Assess antitumor activity of RM-1995.

Side effects data

From 2022 Phase 1 & 2 trial • 35 Patients • NCT03003468
40%
FATIGUE
37%
INFUSION RELATED REACTION
37%
NAUSEA
23%
DIARRHEA
23%
BACK PAIN
23%
ABDOMINAL PAIN
23%
ANOREXIA
20%
ARTHRALGIA
20%
COUGH
20%
NON-CARDIAC CHEST PAIN
17%
DYSPNEA
17%
CONSTIPATION
17%
CHILLS
17%
MYALGIA
13%
DIZZINESS
13%
HEADACHE
13%
PRURITUS
13%
RASH MACULO-PAPULAR
10%
ANEMIA
10%
URTICARIA
10%
SINUS TACHYCARDIA
10%
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
10%
EDEMA LIMBS
10%
ALLERGIC REACTION
10%
ANXIETY
10%
LUNG INFECTION
10%
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
7%
TUMOR PAIN
7%
EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY
7%
HYPERGLYCEMIA
7%
PAIN
7%
PELVIC PAIN
7%
PRODUCTIVE COUGH
7%
PLEURAL EFFUSION
7%
VOICE ALTERATION
7%
VOMITING
7%
FEVER
7%
FLATULENCE
7%
CREATININE INCREASED
7%
HYPERTHYROIDISM
7%
NECK PAIN
7%
DEPRESSION
7%
FLU LIKE SYMPTOMS
7%
LYMPHOCYTE COUNT DECREASED
7%
DYSPEPSIA
7%
FLUSHING
7%
HYPONATREMIA
7%
HYPOTHYROIDISM
7%
URINARY TRACT INFECTION
3%
MUSCLE WEAKNESS LOWER LIMB
3%
ALKALINE PHOSPHATASE INCREASED
3%
DYSPHAGIA
3%
ESOPHAGITIS
3%
GASTROESOPHAGEAL REFLUX DISEASE
3%
OSTEONECROSIS OF JAW
3%
BRONCHOSPASM
3%
PNEUMONITIS
3%
BLURRED VISION
3%
GAIT DISTURBANCE
3%
HEMORRHOIDS
3%
POSTNASAL DRIP
3%
PRESYNCOPE
3%
SORE THROAT
3%
ACUTE KIDNEY INJURY
3%
PERIPHERAL MOTOR NEUROPATHY
3%
DRY SKIN
3%
FLASHING LIGHTS
3%
HYPOMAGNESEMIA
3%
HYPERTENSION
3%
HYPOTENSION
3%
SINUSITIS
3%
SYNCOPE
3%
HEARING IMPAIRED
3%
RASH ACNEIFORM
3%
SOMNOLENCE
3%
COLITIS
3%
HOT FLASHES
3%
RESPIRATORY FAILURE
3%
CONJUNCTIVITIS
3%
MOVEMENTS INVOLUNTARY
3%
NASAL CONGESTION
3%
PARESTHESIA
3%
VAGINAL INFECTION
3%
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
3%
NEUTROPHIL COUNT DECREASED
3%
ALLERGIC RHINITIS
3%
PAIN IN EXTREMITY
3%
SEPSIS
3%
BLOATING
3%
DEHYDRATION
3%
DRY MOUTH
3%
INSOMNIA
3%
MALAISE
3%
PAIN OF SKIN
3%
THROMBOEMBOLIC EVENT
3%
TREMOR
3%
WEIGHT GAIN
100%
80%
60%
40%
20%
0%
Study treatment Arm
Imprime PGG 4 mg/kg
Imprime PGG 2 mg/kg

Trial Design

2Treatment groups
Experimental Treatment
Group I: RM-1995 Photoimmunotherapy + Pembrolizumab (Phased 1b Combination Therapy)Experimental Treatment2 Interventions
Patients with locally advanced cuSCC or HNSCC or metastatic disease that has recurred or progressed, despite all available standard therapies.
Group II: RM-1995 Photoimmunotherapy (Phase 1a Monotherapy)Experimental Treatment1 Intervention
Patients with locally advanced cuSCC or HNSCC or metastatic disease that has recurred or progressed, despite all available standard therapies.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Find a Location

Who is running the clinical trial?

Rakuten Medical, Inc.Lead Sponsor
5 Previous Clinical Trials
414 Total Patients Enrolled
Naomi SchechterStudy ChairRakuten Medical, Inc.
1 Previous Clinical Trials
275 Total Patients Enrolled
Bogdan VereshStudy ChairRakuten Medical, Inc.
~0 spots leftby Sep 2025
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