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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

Must not have

Locoregional recurrent HNSCC with ulceration

History of immune-related adverse events related to administration of anti-PD-1/L1 that led to the termination of the previous anti-PD-1 therapy due to intolerance or toxicity and precludes further PD-1 exposure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

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.

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.

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

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I have never received anti-PD-1 therapy.

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

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

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

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

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

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

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

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

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

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

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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.

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I have never received anti-PD-1 therapy.

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

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I can take care of myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My head or neck cancer has come back in the same area and has caused an open sore.

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I had severe side effects from previous anti-PD-1 cancer therapy, stopping further use.

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I have had pneumonitis treated with steroids or have it now.

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I have HIV or active hepatitis B/C.

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I have symptoms from cancer spread to my brain or its coverings.

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My cancer has spread to more than 5 areas including the original tumor site.

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I have serious heart rhythm problems.

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I am not pregnant or nursing and willing to use contraception if of child-bearing potential.

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I am currently receiving IV antibiotics for an infection.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

[Dose Escalation Part]: Determination of the Recommended Dose

[Dose Expansion Part]: Safety Evaluation at RP2D

Secondary study objectives

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

Nivolumab

2014

Completed Phase 3

~5220

SABR

2013

Completed Phase 2

~70

Pembrolizumab

2017

Completed Phase 2

~2070

NBTXR3

2011

Completed Phase 3

~210

0 / 24Eligibility 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

Squamous Cell Carcinoma Research Study Groups: NBTXR3 activated by SABR followed by anti-PD-1 monotherapy

Squamous Cell Carcinoma 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

~45 spots leftby Apr 2027

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