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Radiopharmaceutical

Radioactive Agent for Cancer (NeoRay Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Advanced Accelerator Applications
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cohort D: patients affected by any metastatic solid tumor type suspected to overexpress GRPR, and with moderate impaired renal function defined as creatinine clearance (calculated using the Cockcroft-Gault formula, or measured) ≥ 30mL/min and < 60mL/min
Patient Eastern Cooperative Oncology Group (ECOG) performance status =< 2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 20, month 6, month 9 and month 12
Awards & highlights

NeoRay Trial Summary

This trial is testing a new treatment for cancer that uses a radioactive agent. They will study how well it works and how safe it is.

Who is the study for?
Adults with advanced solid tumors, especially breast, lung, prostate cancer, GIST or GBM. They must have a tumor that overexpresses GRPR and shows uptake of [68Ga]-NeoB on scans. Participants need at least one measurable lesion and no standard treatment options left. Specific criteria apply for different phases regarding prior treatments and renal function.Check my eligibility
What is being tested?
[177Lu]-NeoB is being tested to see how safe it is and how well it works in treating solid tumors with GRPR expression that absorb [68Ga]-NeoB. The trial will also look at how the body processes the drug and its effects on tumors through various imaging techniques.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions related to organ inflammation due to radiation exposure from radiopharmaceuticals like [177Lu]-NeoB, as well as general side effects such as fatigue or digestive issues common with cancer therapies.

NeoRay Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a metastatic tumor likely to overexpress GRPR and my kidney function is moderately impaired.
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I can take care of myself and am up and about more than half of the day.
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I am an adult with advanced or metastatic cancer.
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My breast cancer is HR-positive, mostly ER-positive, and not HER2-positive.
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My scans show a tumor that absorbs a specific tracer.
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I can take care of myself but might not be able to do heavy physical work.
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I have breast, lung, prostate cancer, GIST, or GBM.
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My breast cancer is HR-positive, ER > 10%, and HER-2 negative.
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I have at least one tumor that can be measured on scans.
Select...
There are no suitable standard treatments for my condition.

NeoRay Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 20, month 6, month 9 and month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 20, month 6, month 9 and month 12 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 I: Determination of Maximum Tolerated Dose (MTD)/ Recommended phase two dose (RP2D) of [177Lu]-NeoB
Phase I: Incidence of dose limiting toxicities (DLTs) of [177Lu]-NeoB
Phase IIa (Cohort D): Absorbed radiation doses of [177Lu]-NeoB in organs and tumor lesions
+2 more
Secondary outcome measures
Phase I and Phase IIa: Adverse Events - [68Ga]-NeoB
Phase I and Phase IIa: Adverse Events [177Lu]-NeoB
Phase I and Phase IIa: Dose interruptions and modifications
+14 more

NeoRay Trial Design

8Treatment groups
Experimental Treatment
Group I: Phase IIaExperimental Treatment2 Interventions
[68 Ga]-NeoB: 50 micrograms/dose at screening [177Lu]-NeoB: dose TBD based on Cohorts I-VI, 3 cycles q6w
Group II: Phase I Cohort VIIExperimental Treatment2 Interventions
[68 Ga]-NeoB: 50 micrograms/dose at screening [177Lu]-NeoB: 120% ECD for 2 cycles (q6w)
Group III: Phase I Cohort VIExperimental Treatment2 Interventions
[68 Ga]-NeoB: 50 micrograms/dose at screening [177Lu]-NeoB: 100% ECD for 2 cycles (q6w)
Group IV: Phase I Cohort VExperimental Treatment2 Interventions
[68 Ga]-NeoB: 50 micrograms/dose at screening [177Lu]-NeoB: 120% ECD for 3 cycles (q6w)
Group V: Phase I Cohort IVExperimental Treatment2 Interventions
[68 Ga]-NeoB: 50 micrograms/dose at screening [177Lu]-NeoB: 100% ECD for 3 cycles (q6w)
Group VI: Phase I Cohort IIIExperimental Treatment2 Interventions
[68 Ga]-NeoB: 50 micrograms/dose at screening [177Lu]-NeoB: 80% ECD for 3 cycles (q6w)
Group VII: Phase I Cohort IIExperimental Treatment2 Interventions
[68 Ga]-NeoB: 50 micrograms/dose at screening [177Lu]-NeoB: 60% ECD for 3 cycles (q6w)
Group VIII: Phase I Cohort IExperimental Treatment2 Interventions
[68 Ga]-NeoB: 50 micrograms/dose at screening [177Lu]-NeoB: 50 mCi (1.85 GBq) cycle 1, 60% Estimated Cumulative Dose (ECD) for cycles 2-4, q6w

Find a Location

Who is running the clinical trial?

Advanced Accelerator ApplicationsLead Sponsor
35 Previous Clinical Trials
2,861 Total Patients Enrolled
Novartis PharmaceuticalsStudy DirectorNovartis Pharmaceuticals
2,157 Previous Clinical Trials
4,012,243 Total Patients Enrolled
7 Trials studying Tumors
237 Patients Enrolled for Tumors

Media Library

[177Lu]-NeoB (Radiopharmaceutical) Clinical Trial Eligibility Overview. Trial Name: NCT03872778 — Phase 1 & 2
Tumors Research Study Groups: Phase IIa, Phase I Cohort VII, Phase I Cohort I, Phase I Cohort II, Phase I Cohort III, Phase I Cohort IV, Phase I Cohort V, Phase I Cohort VI
Tumors Clinical Trial 2023: [177Lu]-NeoB Highlights & Side Effects. Trial Name: NCT03872778 — Phase 1 & 2
[177Lu]-NeoB (Radiopharmaceutical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03872778 — Phase 1 & 2

Frequently Asked Questions

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

How many patients are included in this research project?

"That is accurate. The website clinicaltrials.gov has information indicating that the trial is looking for 86 individuals to participate at 4 different locations. The first posting was on 7/24/2019, with the most recent update being 9/12/2022."

Answered by AI

What are the precedent studies for [177Lu]-NeoB?

"Currently, there are 33 ongoing studies observing the effects of [177Lu]-NeoB. Of these, 3 are large-scale Phase 3 clinical trials. The majority of research surrounding this treatment is based in Perth, Western Australia; however, 241 different locations worldwide are running some form of study regarding [177Lu]-NeoB."

Answered by AI

Are people still being recruited for this clinical trial?

"The clinical trial is actively recruiting patients and has been since it was first posted on 7/24/2019. 86 individuals are needed at 4 sites, as per the latest data from clinicaltrials.gov"

Answered by AI
~20 spots leftby Sep 2025