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NeoplasmsPhase 1/2NeoRayNCT03872778

[177Lu]-NeoB in Patients With Advanced Solid Tumors and With [68Ga]-neoB Lesion Uptake

A Phase 1/2 study testing [177Lu]-NeoB, [68Ga]-NeoB and LCZ696 in people with Neoplasms, run by Advanced Accelerator Applications at 11 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

First in Human (FIH) study to characterize the safety, tolerability, pharmacokinetics (PK), distribution, radiation dosimetry, and anti-tumor activity of [177Lu]-NeoB in patients with advanced solid tumors known to overexpress GRPR and with [68Ga]-NeoB lesion uptake. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
[177Lu]-NeoB, [68Ga]-NeoB and LCZ696
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
11 sitesin 6 countries
Study dates
24 Jul 2019to 27 Nov 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent prior to participation
  • Adult patients with advanced solid tumors known to overexpress GRPR
  • [68Ga]-NeoB tumor lesion uptake on PET/CT or PET/MRI scan at screening visit (>50% of lesions detected with conventional imaging are identified as well by [68Ga]-NeoB uptake)
  • At least one measurable lesion per RECIST 1.1/RANO with a [68Ga]-NeoB uptake
  • Patients for whom no standard therapy is available, tolerated or appropriate
  • Presence of at least one tumor lesion confirmed with functional or structural imaging (PET, SPECT, CT, MRI, bone scan) within 2 months prior to study entry
  • Patient Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Life expectancy more than 6 months.

Who cannot join

  • Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 60 mL/min or serum creatinine > 1.5 x ULN.
  • Platelet count of < 75 x 10e9/L
  • Absolute neutrophil count (ANC) < 1.0 x 10e9/L
  • Hemoglobin < 9 g/dL
  • alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 x upper limit of normal (ULN) if no demonstrable liver metastases of > 5 x ULN in the presence of liver metastases
  • Total bilirubin > 1.5 ULN, except for patients with documented Gilbert's syndrome who are eligible if total bilirubin ≤ x ULN
Show all 33Show fewer
  • Serum amylase and/or lipase > 1.5 ULN
  • Known or expected hypersensitivity to [177Lu]-NeoB, [68Ga]-NeoB or any of their excipients
  • Impaired cardiac function or clinically significant cardiac disease, including any of the following:
  • Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (New York Heart Association (NHYA) grade ≥2), uncontrolled arterial hypertension or clinically significant arrhythmia
  • LVEF < 50% as determined by echocardiogram (ECHO)
  • QTcF > 470 msec for females and QTcF >450 msec for males on screening electrocardiogram (ECG) or congenital long QT syndrome
  • Acute myocardial infarction or unstable angina pectoris < 3 months prior to study entry
  • Patients with diabetes mellitus requiring insulin treatment and/or with clinical signs or with fasting plasma glucose > 160 mg/dL (8.9 mmol/L)
  • Patients with history of or ongoing acute or chronic pancreatitis
  • Prior administration of a radiopharmaceutical with therapeutic intent within a period corresponding to 10 half-lives of the radionuclide used in such radiopharmaceutical
  • Prior External Beam Radiation Therapy (EBRT) to more than 25% of the bone marrow
  • Patients with a bone scan showing an excessive skeletal radiopharmaceutical uptake with absent or faint activity in soft tissues and the genitourinary tract due to diffuse bone/bone marrow metastases in bone scan also called a "superscan"
  • Prior treatment with Radium=223
  • Patients who have changed the dose of systemic steroid therapy within less than 2 weeks prior to study entry or patients for whom steroid dose increase is anticipated during the study.
  • Patients who have received prior systemic anti-cancer treatment within the following time frames:
  • Cyclical chemotherapy within a period that is shorter than the cycle length used for that treatment (e.g. 6 weeks for nitrosourea, mitomycin-C) prior to starting study treatment
  • Biologic therapy (e.g. antibodies), continuous or intermittent small molecule therapeutics, or any other investigational agents within a period which is ≤ 5T1/2 or ≤ 4 weeks (whichever is longer) prior to study entry
  • History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
  • Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type
  • pregnant or breast-feeding women
  • women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, are not allowed to participate in this study UNLESS they are using highly effective methods of contraception throughout the study and for 6 months after study drug discontinuation. Highly effective contraception methods include:
  • Total abstinence
  • Male or female sterilization
  • Combination of any two of the following (a+b or a+c or b+c)
  • Use of oral, injected, or implanted hormonal methods of contraception. In case of use of oral contraception, women should be stable on the same pill for a minimum of 3 months before taking study treatment.
  • Placement of an intrauterine device (IUD) or intrauterine system (IUS).
  • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository. Post-menopausal women are allowed to participate in this study. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum Follicle-Stimulating Hormone (FSH) levels > 40 mIU/mL [for US only: and estradiol < 20 pg/mL] or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to screening. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment is she considered not of child bearing potential. Sexually active males must use a condom during intercourse while taking the drug and for 6 months after stopping treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.

Trial locations and contacts

11 sites in 6 countries.

11 sites in 6 countries

United States6 sites

  • John Hopkins University

    Baltimore, Maryland, 21287

  • City of Hope

    Duarte, California, 91010

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Pittsburgh University

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Stanford University

    Stanford, California, 94305

Other trials in United States

Austria1 site

  • Medical University of Innsbruck

    Innsbruck

Other trials in Austria

France1 site

  • CHU de Grenoble

    La Tronche

Other trials in France

Netherlands1 site

  • Erasmus MC

    Rotterdam

Other trials in Netherlands

Spain1 site

  • Vall d'Hebron Institute of Oncology

    Barcelona

Other trials in Spain

United Kingdom1 site

  • Addenbroke's hospital

    Cambridge

Other trials in United Kingdom

About this study

Official title: A Phase I/IIa Open-label, Multi-center Study to Evaluate the Safety, Tolerabiity, Whole-body Distribution, Radiation Dosimetry and Anti-tumor Activity of [177Lu]-NeoB Administered in Patients With Advanced Solid Tumors Known to Overexpress Gastrin-releasing Peptide Receptor (GRPR)

First in Human (FIH) study to characterize the safety, tolerability, pharmacokinetics (PK), distribution, radiation dosimetry, and anti-tumor activity of [177Lu]-NeoB in patients with advanced solid tumors known to overexpress GRPR and with [68Ga]-NeoB lesion uptake.

Read the detailed description

This study was designed to establish whether the ligand NeoB, a high affinity antagonist for GRPR, could be used in a theragnostic approach for selection and therapy of GRPRexpressing malignancies: radiolabeled with (1) Gallium 68 (68Ga) to identify lesions and with (2) Lutetium-177 (177Lu) for the treatment of these lesions.

Conditions
Neoplasms
Being tested
[177Lu]-NeoB, [68Ga]-NeoB, LCZ696
Keywords
AAA603, [177Lu]-NeoB, [68Ga]-neoB, whole-body distribution, radiation dosimetry, anti-tumor activity, Advanced solid tumors, Overexpress gastrin-releasing peptide receptor, GRPR, Lutetium-177 (177Lu)
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [177Lu]-NeoBDrug

    Also called Lutetium NeoB, AAA603

    [177Lu]-NeoB: peptide receptor radionuclide therapy

  • [68Ga]-NeoBDrug

    Also called Gallium NeoB

    [68Ga]-NeoB radioactive diagnostic agent

  • LCZ696Drug

    Also called sacubitril, valsartan

    dose strength 49/51 mg, film-coated tablets for oral use

Study groups in NCT03872778
Study groupRoleWhat they receive
Phase I Cohort 1 (DL1(50mCi + 150mCi)ExperimentalParticipants received the 1.85 GBq (50mCi) +/- 10% of [177Lu]-NeoB at cycle 1 and then received 5.55 GBq (150mCi）+/- 10% of [177Lu]-NeoB for at least 3 cycles.
Receives: Drug: [177Lu]-NeoB; Drug: [68Ga]-NeoB
Phase I Cohort 2 (DL2 200mCi)ExperimentalParticipants received the 9.25 GBq (250mCi) +/- 10% of [177Lu]-NeoB once every 6 weeks for at least 3 cycles.
Receives: Drug: [177Lu]-NeoB; Drug: [68Ga]-NeoB
Phase I Cohort 3 (DL3 250mCi)ExperimentalParticipants received the 11.1 GBq (300mCi) +/- 10% of [177Lu]-NeoB once every 6 weeks for at least 3 cycles.
Receives: Drug: [177Lu]-NeoB; Drug: [68Ga]-NeoB
Phase II Cohort A (Breast Cancer)ExperimentalParticipants received the 9.25 GBq (250mCi) +/- 10% of [177Lu]-NeoB once every 6 weeks for at least 3 cycles.
Receives: Drug: [177Lu]-NeoB; Drug: [68Ga]-NeoB
Phase II Cohort B (Prostate Cancer)ExperimentalParticipants received the 9.25 GBq (250mCi) +/- 10% of [177Lu]-NeoB once every 6 weeks for at least 3 cycles.
Receives: Drug: [177Lu]-NeoB; Drug: [68Ga]-NeoB
Phase II Cohort C (Gastro Intestinal Stromal Tumor (GIST))ExperimentalParticipants received the 9.25 GBq (250mCi) +/- 10% of [177Lu]-NeoB once every 6 weeks for at least 3 cycles.
Receives: Drug: [177Lu]-NeoB; Drug: [68Ga]-NeoB
Phase II Cohort D (Renal Impairment)ExperimentalThese were participants with any advanced/metastatic solid tumor type, and with moderate impaired renal function. The participants received the 9.25 GBq (250mCi) +/- 10% of [177Lu]-NeoB once every 6 weeks for at least 3 cycles.
Receives: Drug: [177Lu]-NeoB; Drug: [68Ga]-NeoB
Phase II Cohort E (Breast, Prostate, GIST)ExperimentalThese participants were eligible for enrollment in any of the three advanced/metastatic tumor type (as defined for cohorts A,B,C. The participants received the 5.55 GBq (150mCi) +/- 10% of [177Lu]-NeoB and neprilysin inhibitor (NEPi) LCZ696 in cycle 1 and then 9.25 GBq (250mCi) +/- 10% of [177Lu]-NeoB once every 6 weeks for at least 3 cycles.
Receives: Drug: [177Lu]-NeoB; Drug: [68Ga]-NeoB; Drug: LCZ696

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I: Incidence of dose limiting toxicities (DLTs) of [177Lu]-NeoB

    A dose-limiting toxicity (DLT) is defined as a clinically relevant adverse event or abnormal laboratory value not attributable to the disease or disease-related processes under investigation, considered possibly related to [177Lu]-NeoB that occurs within 42 days following the first administration of [177Lu]-NeoB (cycle 1) and meets any of the criteria listed in Table 6-4 (Criteria for defining dose-limiting toxicities).

    Measured: Within 42 days following the first administration of [177Lu]-NeoB

  2. Phase I: Determination of Maximum Tolerated Dose (MTD)/ Recommended phase two dose (RP2D) of [177Lu]-NeoB

    The maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D) of [177Lu]-NeoB will be identified:

    1. MTD is defined as the lowest single dose at which 25% or more of the patients experienced a DLT during the first cycle (6 weeks).
    2. RP2D is defined as the single dose level below the MTD. The number of cycles recommended for Phase II will be defined based on the cumulative dose toxicities reported during Phase I.

    Measured: Within 42 days following the first administration of [177Lu]-NeoB

  3. Phase IIa (Cohorts A, B and C): Individual clinical responses assessed by Response Evaluation Criteria In Solid Tumors (RECIST v1.1)

    To assess the anti-tumor activity of [177Lu]-NeoB at the RP2D across different solid tumors

    Measured: 25 months

  4. Phase IIa (Cohort E): Absorbed radiation doses of [177Lu]-NeoB in organs and tumor lesions

    Absorbed radiation doses in organs and tumor lesions will be summarized with descriptive statistics. Lesion number will be assigned by dosimetry expert.

    Measured: 6 weeks

  5. Phase IIa (Cohort E): Concentration of [177Lu]-NeoB in blood over time and derived PK parameters

    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Concentration of [177Lu]-NeoB will be listed and summarized using descriptive statistics.

    Measured: 6 weeks

  6. Phase I: identify maximum tolerated and/or recommended Phase II dose

    Measured: 18 months

  7. Phase II: assess disease control rate 20 weeks after completion of treatment

    Measured: 18 months

Secondary outcomes (27)

  1. Phase I: Tissue Activity Curves (ACs)

    Tissue activity curves (ACs) will be generated from the amount of radioactivity in one given tissue at a given moment over the amount of radioactivity present in the blood at that given moment.

    Measured: 6 weeks

  2. Phase I: Time Activity Curves (ACs)

    Time Activity Curves (ACs) describe the percentage of the activity injected versus time.

    Measured: 6 weeks

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

    Absorbed radiation doses in critical organs (e.g. kidneys, bone marrow, pancreas) will be summarized with descriptive statistics. Lesion number will be assigned by dosimetry expert.

    Measured: 6 weeks

  4. Phase I: Urinary excretion of [177Lu]-NeoB

    Urine samples will be collected over specified time intervals and analyzed for radioactivity using a gamma counter. The radioactivity excreted in urine will be summarized using descriptive statistics.

    Measured: 6 weeks

  5. Phase I: Half-life of [177Lu]-NeoB in blood

    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. The half-live will be listed and summarized using descriptive statistics.

    Measured: 6 weeks

  6. Phase I: Residence time of [177Lu]-NeoB in organs and tumor lesions

    Residence time in organs and tumors lesions will be summarized with descriptive statistics. Lesion number will be assigned by dosimetry expert.

    Measured: 6 weeks

  7. Phase I: Individual objective response and Duration of Response (DOR)

    DOR is defined as the duration of time between the date of first documented response (CR or PR) in soft tissue according to PCWG3 modified RECIST 1.1, and the date of first documented progression or death due to any cause.

    Measured: 25 months

  8. Phase IIa (Cohorts A, B and C): Absorbed radiation doses of [177Lu]-NeoB in organs and tumor lesions

    Absorbed radiation doses in organs and tumor lesions will be summarized with descriptive statistics. Lesion number will be assigned by dosimetry expert.

    Measured: 6 weeks

  9. Phase IIa (Cohorts A, B and C): Concentration of [177Lu]-NeoB in blood over time and derived PK parameters

    Venous whole blood samples will be collected for activity-based pharmacokinetics characterization. Concentration of [177Lu]-NeoB will be listed and summarized using descriptive statistics.

    Measured: 6 weeks

  10. Phase IIa (Cohorts A, B and C): Changes from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

    The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A higher score for the functioning scales and global health status denote a better level of functioning (i.e. a better state of the patient), while higher scores on the symptom and single-item scales indicate a higher level of symptoms (i.e. a worse state of the patient).

    Measured: 15 months

  11. Phase IIa (Cohort E): Adverse Events for [177Lu]-NeoB when co-administered with the NEPi LCZ696 in Cycle 1

    The distribution of adverse events for [177Lu]-NeoB when co-administered with the neprilysin inhibitor (NEPi) LCZ696 will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.

    Measured: 25 months

  12. Phase IIa (Cohort E): Dose interruptions and modifications for [177Lu]-NeoB when co-administered with the NEPi LCZ696 in Cycle 1

    Measured: Within 42 days following the first administration of [177Lu]-NeoB (Cycle 1)

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

    The distribution of adverse events for [177Lu]-NeoB as monotherapy will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.

    Measured: 25 months

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

    The distribution of adverse events for [68Ga]-NeoB will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.

    Measured: 25 months

  15. Phase I and Phase IIa: Dose interruptions and modifications

    Measured: 25 months

  16. Determine Tissue Activity Curves (ACs) [177Lu-NeoB]

    ratio of radioactivity in tissue vs blood

    Measured: 18 months

  17. Determine Time Activity Curves

    ratio of % activity injected vs time

    Measured: 18 months

  18. Absorbed radiation dose

    absorbed radiation dose to critical organs

    Measured: 18 months

  19. Urinary excretion of [177Lu]-NeoB

    measure amount of [177Lu]-NeoB excreted in Urine

    Measured: 18 months

  20. Blood Half-life of [177Lu]-NeoB

    Measured: 18 months

  21. Organ Residence time of [177Lu]-NeoB

    Measured: 18 months

  22. Objective Response Rate

    Measured: 18 months

  23. Duration of Response

    Measured: 18 months

  24. Progression Free Survival

    Measured: 18 months

  25. Adverse Events [177Lu-NeoB]

    Measured: 18 months

  26. Dose modifications

    Measured: 18 months

  27. Adverse Events [68Ga-NeoB]

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2019
  2. Study start24 Jul 2019
  3. Primary completion7 Jan 2025
  4. Study completion27 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Phase I: dose range finding to identify Recommended Phase II Dose Phase IIa: assessment of anti-tumor activity
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03872778
Sponsor's protocol ID
CAAA603A12101
Other IDs
2023-507170-41-00, 2023
Acronym
NeoRay
Status last verified
Jul 2026
First submitted
11 Mar 2019
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Taunk NK, Escorcia FE, Lewis JS, Bodei L. Radiopharmaceuticals for Cancer Diagnosis and Therapy: New Targets, New Therapies-Alpha-Emitters, Novel Targets. Cancer J. 2024 May-Jun 01;30(3):218-223. doi: 10.1097/PPO.0000000000000720.

    PubMed 38753757

  • Sundlov A, Sjogreen-Gleisner K. Peptide Receptor Radionuclide Therapy - Prospects for Personalised Treatment. Clin Oncol (R Coll Radiol). 2021 Feb;33(2):92-97. doi: 10.1016/j.clon.2020.10.020. Epub 2020 Nov 12.

    PubMed 33189510

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing [177Lu]-NeoB, [68Ga]-NeoB and LCZ696 in people with Neoplasms, run by Advanced Accelerator Applications at 11 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Austria, France, Netherlands, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Incidence of dose limiting toxicities (DLTs) of [177Lu]-NeoB (time frame: Within 42 days following the first administration of [177Lu]-NeoB). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03872778, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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