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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

Study Summary

This trial is testing a new cancer treatment that uses light to kill cancer cells. The treatment will be given alone or with another cancer drug to see if it is safe and effective.

Eligible Conditions

Head and Neck Squamous Cell Carcinoma
Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Assess antitumor activity of RM-1995.

Serum concentration of IR-700.

Serum concentration of RM-1995.

+1 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Pneumothorax

Malnutrition, Hypercalcemia and Weakness

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rakuten Medical, Inc.Lead Sponsor

5 Previous Clinical Trials

427 Total Patients Enrolled

Naomi SchechterStudy ChairRakuten Medical, Inc.

1 Previous Clinical Trials

275 Total Patients Enrolled

Bogdan VereshStudy ChairRakuten Medical, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity for participants to join this trial currently?

"According to clinicaltrials.gov, recruitment for this research project is currently in progress. The trial was originally published on the 24th of March 2022 and underwent its last edit on April 6th."

Answered by AI

To what extent has RM-1995 been tested for safety and efficacy?

"Based on our assessment, RM-1995 was deemed to have a safety ranking of 1 due to its Phase 1 status that has limited clinical data backing both efficacy and safety."

Answered by AI

What is the geographical distribution of this trial's implementation?

"The ongoing clinical trial is being conducted in multiple locations, including UCSF Helen Diller Family Comprehensive Cancer Center (San Francisco, California), UCSD Head and Neck Oncology (La Jolla, Texas) City of Hope National Medical Centre (Duarte, Kentucky) among 6 other sites."

Answered by AI

What is the scale of participation in this experiment?

"This clinical trial necessitates the recruitment of 36 eligible patients. UCSF Helen Diller Family Comprehensive Cancer Centre and UCSD Head and Neck Oncology are two of many centres that can facilitate participation in this experiment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

RM-1995 Photoimmunotherapy, as Monotherapy or Combined With Pembrolizumab, in Patients With Advanced CuSCC and HNSCC

2022. "RM-1995 Photoimmunotherapy, as Monotherapy or Combined With Pembrolizumab, in Patients With Advanced CuSCC and HNSCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05220748.