What side effects are associated with this type of intervention?

Common side effects of radiolabeled therapies, such as [177Lu]-NeoB, include fatigue, nausea, and hematologic toxicities like neutropenia and thrombocytopenia. These treatments may also cause radiation-related side effects, including damage to nearby healthy tissues. Other common cancer treatments, such as chemotherapy, can lead to side effects like diarrhea, rash, alopecia, and neuropathy, while immunotherapy may cause immune-related adverse events such as pneumonitis, colitis, and endocrinopathies.

What prior FDA approvals exist?

Radiolabeled therapeutics have been approved by the FDA for the treatment of various tumors. One notable example is Lutetium Lu 177 vipivotide tetraxetan, which targets PSMA in metastatic castration-resistant prostate cancer (CRPC). This treatment has shown significant efficacy in improving progression-free survival and overall survival in patients. Another example is Radium-223 dichloride, approved for the treatment of metastatic CRPC with symptomatic bone metastases. These therapies work by delivering targeted radiation to cancer cells, minimizing damage to surrounding healthy tissue.

What other types of research exist?

Promising alternatives to [177Lu]-NeoB for tumor patients include: 1) [68Ga]-PSMA-11 for prostate cancer, which targets the prostate-specific membrane antigen (PSMA) and has shown high diagnostic accuracy and therapeutic potential. 2) Rucaparib and Niraparib, PARP inhibitors for prostate cancer with homologous recombination repair (HRR) deficiencies, showing significant efficacy in clinical trials. 3) Pembrolizumab, an immune checkpoint inhibitor, used in neoadjuvant and adjuvant settings for melanoma, demonstrating improved survival outcomes.

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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.

Must not have

History of or ongoing acute or chronic pancreatitis

Women of child-bearing potential not using highly effective contraception

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 25 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new radioactive treatment for adults with advanced cancers that have a specific marker. The treatment aims to see if it is safe and effective by targeting and killing cancer cells using radiation.

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.

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.

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.

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.

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There are no suitable standard treatments for my condition.

Exclusion Criteria

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

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I have had or currently have pancreatitis.

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I am a woman able to have children and am not using strong birth control methods.

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I am receiving [223Ra]-therapy for widespread bone or bone-marrow cancer.

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I have heart problems that affect my daily activities.

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My diabetes is not well-controlled, or I have high blood sugar levels.

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My side effects from previous cancer treatments are mild, except for hair loss.

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I have issues controlling my urine or emptying my bladder.

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I have had radiation therapy to over 25% of my bone marrow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 25 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~25 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 25 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 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 E): Absorbed radiation doses of [177Lu]-NeoB in organs and tumor lesions

+2 more

Secondary study objectives

Phase I and Phase IIa: Adverse Events for [177Lu]-NeoB

Phase I and Phase IIa: Adverse Events for [68Ga]-NeoB

Phase I: Absorbed radiation doses of [177Lu]-NeoB in critical organs

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

10Treatment groups

Experimental Treatment

Group I: Phase IIa:Cohort EExperimental Treatment3 Interventions

\[68 Ga\]-NeoB: 50 micrograms/dose at screening \[177Lu\]-NeoB: dose TBD based on Cohorts I-VI, 3 cycles q6w LCZ696: co-administered with \[177Lu\]-NeoB

Group II: Phase IIa: Cohort DExperimental Treatment2 Interventions

\[68 Ga\]-NeoB: 50 micrograms/dose at screening \[177Lu\]-NeoB: dose TBD based on Cohorts I-VI, 3 cycles q6w

Group III: Phase IIa: Cohort CExperimental Treatment2 Interventions

\[68 Ga\]-NeoB: 50 micrograms/dose at screening \[177Lu\]-NeoB: dose TBD based on Cohorts I-VI, 3 cycles q6w

Group IV: Phase IIa: Cohort BExperimental Treatment2 Interventions

\[68 Ga\]-NeoB: 50 micrograms/dose at screening \[177Lu\]-NeoB: dose TBD based on Cohorts I-VI, 3 cycles q6w

Group V: Phase IIa: Cohort AExperimental Treatment2 Interventions

\[68 Ga\]-NeoB: 50 micrograms/dose at screening \[177Lu\]-NeoB: dose TBD based on Cohorts I-VI, 3 cycles q6w

Group VI: Phase I: Cohort VExperimental Treatment2 Interventions

\[68 Ga\]-NeoB: 50 micrograms/dose at screening \[177Lu\]-NeoB: 120% ECD for 3 cycles (q6w)

Group VII: Phase I: Cohort IVExperimental Treatment2 Interventions

\[68 Ga\]-NeoB: 50 micrograms/dose at screening \[177Lu\]-NeoB: 100% ECD for 3 cycles (q6w)

Group VIII: Phase I: Cohort IIIExperimental Treatment2 Interventions

\[68 Ga\]-NeoB: 50 micrograms/dose at screening \[177Lu\]-NeoB: 80% ECD for 3 cycles (q6w)

Group IX: Phase I: Cohort IIExperimental Treatment2 Interventions

\[68 Ga\]-NeoB: 50 micrograms/dose at screening \[177Lu\]-NeoB: 60% ECD for 3 cycles (q6w)

Group X: 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LCZ696

2016

Completed Phase 4

~14630

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Radiolabeled therapies, like [177Lu]-NeoB, work by targeting specific receptors overexpressed on tumor cells, such as the Gastrin-Releasing Peptide Receptor (GRPR). These treatments deliver radiation directly to the tumor, minimizing damage to healthy tissues. This targeted approach is significant for tumor patients as it increases treatment effectiveness and reduces side effects, leading to better patient outcomes.