← Back to Search

Nanoparticle

NBTXR3 + Radiotherapy for Cancer

Phase 1

Recruiting

Research Sponsored by Nanobiotix

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Expansion Cohort 2: Has not received prior anti-PD-1 therapy (i.e., anti-PD-1 naïve)

Biopsy-confirmed cancer diagnosis indicated to receive anti-PD-1 therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing a new cancer treatment that involves injecting a drug directly into tumors and combining it with anti-PD-1 therapy. The goal is to see if this is a safe and effective treatment for cancer.

Who is the study for?

This trial is for adults with advanced cancers like lung, kidney, bladder, skin cancer and more who have a life expectancy over 12 weeks. They must be able to receive radiotherapy and not have had certain treatments recently or suffer from conditions like severe heart failure or active infections.Check my eligibility

What is being tested?

The study tests NBTXR3 injected into tumors activated by radiotherapy alongside anti-PD-1 therapy (Pembrolizumab or Nivolumab). It's an open-label Phase I trial meaning everyone gets the treatment and doctors know what they're giving.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site, typical chemotherapy effects such as fatigue, nausea, inflammation due to immune response changes. Radiotherapy may cause skin irritation or other localized issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have never received anti-PD-1 therapy.

Select...

My cancer diagnosis was confirmed by a biopsy and is recommended for anti-PD-1 therapy.

Select...

My cancer has spread to a part of my lung that hasn't been treated with radiation.

Select...

You have a tumor in a certain location in the body that may or may not have been treated with radiation before.

Select...

My cancer has spread to a part of my liver that hasn't been treated with radiation.

Select...

I have head, neck, lung, or liver cancer that can't be removed by surgery but can be treated with radiation.

Select...

My cancer has spread and I have at least one tumor that can be targeted with radiation.

Select...

I was treated with anti-PD-1 therapy but it stopped working.

Select...

I have had anti-PD-1 therapy before and it did not work for me.

Select...

I have had anti-PD-1 therapy and it didn't work as expected.

Select...

I have a tumor that can be measured and is accessible for direct injection.

Select...

You have a specific type of cancer that has spread, and you have at least one specific type of lesion that can be treated with radiation therapy.

Select...

I have never received anti-PD-1 therapy.

Select...

My tumor cannot be removed surgically and is in a previously treated area but can be re-irradiated.

Select...

I can take care of myself and perform daily activities.

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

[Dose Escalation Part]: Determination of the Recommended Dose

[Dose Expansion Part]: Safety Evaluation at RP2D

Secondary outcome measures

Assessment of the safety and feasibility of R3/RT/PD-1

Evaluation of the anti-tumor response of R3/RT/PD-1

Evaluation of the body kinetic profile of intratumorally injected NBTXR3

Trial Design

1Treatment groups

Experimental Treatment

Group I: NBTXR3 activated by SABR followed by anti-PD-1 monotherapyExperimental Treatment4 Interventions

Intratumoral injection of NBTXR3 followed by SABR followed by monotherapy with nivolumab or pembrolizumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SABR

2013

Completed Phase 2

~70

Nivolumab

2014

Completed Phase 3

~4750

Pembrolizumab

2017

Completed Phase 2

~2010

NBTXR3

2011

Completed Phase 3

~210

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

NanobiotixLead Sponsor

6 Previous Clinical Trials

805 Total Patients Enrolled

Elsa Borghi, MDStudy DirectorNanobiotix

Pavel Tyan, MDStudy DirectorNanobiotix

Media Library

NBTXR3 (Nanoparticle) Clinical Trial Eligibility Overview. Trial Name: NCT03589339 — Phase 1

Immunotherapy Research Study Groups: NBTXR3 activated by SABR followed by anti-PD-1 monotherapy

Immunotherapy Clinical Trial 2023: NBTXR3 Highlights & Side Effects. Trial Name: NCT03589339 — Phase 1

NBTXR3 (Nanoparticle) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03589339 — Phase 1

Frequently Asked Questions

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

What potential hazards have been linked to the use of NBTXR3?

"With only limited data available on safety and efficacy, our evaluation of NBTXR3's risk profile was rated a 1."

Answered by AI

Is the recruitment phase for this research still open?

"Affirmative. According to the clinicaltrials.gov database, this research trial is actively seeking participants; it was first posted on January 16th 2019 and last revised October 25th 2022. 145 candidates need to be enrolled from 11 distinct locations."

Answered by AI

What is the participant capacity for this clinical investigation?

"This clinical trial necessitates the inclusion of 145 qualified participants. Patients may be recruited from any one of several sites, such as University of Chicago Medical Center in Chicago and James Graham Brown Cancer Centre at University of Louisville in Kentucky."

Answered by AI

How many Canadian healthcare facilities are conducting research on this topic?

"Recruiting for this trial is occuring at 11 different medical centres, including the University of Chicago Medical Center in Chicago, University of Louisville, James Graham Brown Cancer Center in Louisville and Banner MD Anderson Cancer Centre in Gilbert."

Answered by AI