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Neuroendocrine TumorPhase 1NCT03466216

Phase 1 Study of AlphaMedix™ in Adult Subjects With SSTR (+) NET

A Phase 1 study testing AlphaMedix in people with Neuroendocrine Tumor, run by Orano Med LLC at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

AlphaMedix™ (²¹²Pb-DOTAMTATE) is a radiotherapeutic drug indicated in subjects with unresectable, metastatic somatostatin receptor (SSTR) positive neuroendocrine tumors (NETs). Because 212Pb is an in vivo generator of alpha particles, it is particularly suitable for SSTR therapy applications. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neuroendocrine Tumor
What is being tested?
AlphaMedix
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
5 Feb 2018to 6 Apr 2023
Phase
Phase 1
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

  • ECOG status 0-2.
  • Life expectancy of at least 12 weeks.
  • Histologically confirmed diagnosis of SSTR (+) NET, unresectable or metastatic.
  • Measurable disease per RECIST 1.1 on CT/MRI scans, defined as at least 1 lesion with ≥ 1 cm in longest diameter (LD) (lymph nodes along short axis).
  • Appropriate diagnostic imaging studies, at the discretion of the PI including but not limited to CT, MRI, 18F-FDG PET/CT, NAF PET/CT bone scan, ultrasound, etc. of the tumor region or suspected area within the 4 weeks of dosing day.
  • SSTR(+) disease, as evidenced by available FDA approved SSTR imaging (SRI) within 4 weeks prior to the first cycle.
  • All FDA-approved therapies for which the subject is eligible have been exhausted.
  • Recent blood test results (within 2 weeks pre-dose) as follows: Sufficient bone marrow capacity as defined by white blood cell (WBC) ≥2,500/µl and WBC ≥2,000/µl for subsequent cycles; platelets ≥ 100,000/µl for the first treatment and ≥75,000 for the subsequent therapies, hemoglobin (HgB) ≥8.9 g/dl for the first treatment and 8.0 g/dl for the subsequent therapies, ANC ≥1,500/µl for the first treatment and ≥1,000/µl; for the subsequent therapies; ALT, AST values ≤3 times upper limit of normal (ULN); Bilirubin: ≤3 times ULN; Serum creatinine ≤150 µmol/liter or 1.7 mg/dl; Negative pregnancy test in women capable of child-bearing within 48 hours of administration; Serum albumin > 3.0 g/L (<3.0 g/L may be acceptable at the discretion of PI, if PT, PTT, and INR are within normal range)

Who cannot join

  • Prior whole-body radiotherapy and PRRT using 177Lu/90Y/111In- DOTATATE/DOTATOC or TAT
  • Known hypersensitivity to 68Gallium, Octreotate, or any of the excipients of 68Ga-DOTATATE, AA infusion or AlphaMedix™.
  • Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 1 day) prior to administration of investigational drug.
  • Subjects with unusual hematological parameters, including an increased mean corpuscular volume (MCV) (>100,000), and especially in those who had previous chemotherapy, the advice of a hematologist should be sought for adequate further work-up to rule out myelodysplastic syndrome (MDS).
  • Any subject who is taking concomitant medications that decrease renal function (such as aminoglycoside antibiotics).
  • Female subjects who are pregnant, lactating or women of childbearing potential not willing to practice effective contraceptive techniques during the study period and for 8 weeks post-injection or male subjects who have female partners of childbearing potential not willing to practice abstinence or effective contraception, during the study period and for 8 weeks post-injection.
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  • Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
  • Indication for surgical lesion removal with curative potential
  • Known brain metastases; unless these metastases have been treated and stabilized 6 months prior to enrollment
  • Completion of: (1) cytotoxic chemotherapy for less than 6 weeks; (2) a biological agent for less than 5 half-lives; and (3) radiation therapy for less than 6 weeks prior to study enrolment,
  • Uncontrolled congestive heart failure; subjects suspected of having this condition need to show ejection fraction of >55% as determined by multigated acquisition (MUGA) scan.
  • Carcinoid heart disease: Prior history of torsade de pointe, or congenital long QT syndrome; Conditions with screening ECG repolarization difficult to interpret, or showing significant abnormalities. This includes, but is not limited to: high degree AV block, pacemaker, atrial fibrillation or flutter; QTcF interval > 480 msec on screening ECG; Significant hypokalemia at screening (Potassium <3.5 mMol/L); Significant hypomagnesemia at screening (Mg++ <0.7 mMol/L)
  • GFR < 35 mL/min

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Excel Diagnostics and Nuclear Oncology Center

    Houston, Texas, 77042

Other trials in United States

About this study

Official title: A Phase 1, Non-Randomized, Open-Label, Dose Escalation, Single-Center Study to Determine the Safety, Bio-distribution, and Preliminary Effectiveness of AlphaMedix™ in Adult Subjects With SSRT(+) NETs.

AlphaMedix™ (²¹²Pb-DOTAMTATE) is a radiotherapeutic drug indicated in subjects with unresectable, metastatic somatostatin receptor (SSTR) positive neuroendocrine tumors (NETs). Because 212Pb is an in vivo generator of alpha particles, it is particularly suitable for SSTR therapy applications.

This drug addresses an unmet need in the field of peptide receptor radionuclide therapy (PRRT) for NETs. Substitution of an alpha emitter (²¹²Pb) for the beta emitters currently being used (i.e., 177Lu or 90Y) will provide significantly higher Linear Energy Transfer (LET) and a shorter path length. Higher LET particles should cause more tumor cell death. Shorter path length should result in less collateral damage of the normal tissue and therefore less side effects for subjects receiving the drug.

Read the detailed description

This dose escalation study will include a maximum of 50 subjects with histologically confirmed NET, a positive somatostatin analogue scan, and no prior history of PRRT therapy.

The study will begin with a single ascending dose (SAD) of AlphaMedix™ administered by IV. Subsequent cohorts will receive an incremental 30% increase that will continue until tumor response or DLT. Once tumor response is observed, the study will convert to a Multiple Ascending Dose (MAD) regimen. The MAD treatment regimen will start with the previous safe cohort's dose and will consist of 3 IV administrations of AlphaMedix™ at 8-week intervals. Subsequent cohorts will receive an incremental 30% increase that will continue until tumor response or DLT.

The primary objective is to assess the safety and dose limiting toxicity (DLT) using ascending doses of AlphaMedix™. The secondary objectives are to determine the pharmacokinetic properties and preliminary effectiveness of AlphaMedix™.

Being tested
AlphaMedix
Keywords
somatostatin receptor
Medical subject headings
Neuroendocrine Tumors

What participants receive

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

  • AlphaMedixDrug

    Also called Pb212-octreotide analog

    There is only a single treatment intervention.

Study groups in NCT03466216
Study groupRoleWhat they receive
AlphaMedixExperimentalThere is only a single treatment arm.
Receives: Drug: AlphaMedix

What is being measured

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

  1. To determine dose-limiting toxicity (DLT)

    DLT is defined as non-hematological toxicity - all Grade 4 and Grade 3 (except alk. phos.) that is not responsive to NMT 72 hours of supportive care - and all hematological toxicity that does not recover to NMT than Grade 2 within 8 wks of dose administration.

    Measured: 8 weeks post-injection

  2. Incidence of treatment-emergent AEs and SAEs as assessed by CTCAE v. 4

    AEs will be recorded both spontaneously by the patient during the treatment period and at all safety follow ups (2 wks, 4 wks, 6 wks, 8 wks post each injection and 3 mo, 6 mo, 10 mo, 12 mo, 15 mo, 18 mo, 21 mo, and 24 mo post last injection)

    Measured: 32 months after enrollment

Secondary outcomes (3)

  1. Partial or complete response assessed by modified RECIST v1.1

    CT/MRI or 18FDG-PET/CT (for patients who are FDG-avid at baseline) will be used to measure tumor size

    Measured: 32 months after enrollment

  2. To determine effective blood clearance and cumulative blood activity of 212-Pb

    Blood will be taken at Time 0, 1 hr, 4 hr and 24 hr post-injection and measured for activity in an auto gamma counter

    Measured: 24 hours post-injection

  3. To determine the rate and extent of 212-Pb elimination in urine

    Bladder will be emptied just prior to injection and qualitative urine collections will be done 0-1 hr, 1-4 hr and 4-24 hr post-injection and measured for activity in an auto gamma counter

    Measured: 24 hours post-injection

Timeline

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

  1. First posted15 Mar 2018
  2. Study start5 Feb 2018
  3. Primary completion6 Apr 2023
  4. Study completion6 Apr 2023

Why it stopped: Terminated for non-safety reasons.

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03466216
Sponsor's protocol ID
ALPHAMEDIX01
Status last verified
Jun 2025
First submitted
11 Jan 2018
Last updated
10 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AlphaMedix in people with Neuroendocrine Tumor, run by Orano Med LLC at 1 site in United States.

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 13 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: stopped early, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 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.

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 was stopped early (reason given: Terminated for non-safety reasons.). Results are not available in the source record.

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?

To determine dose-limiting toxicity (DLT) (time frame: 8 weeks post-injection). The study lists 2 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 NCT03466216.

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 10 Jun 2025.

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