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Advanced Solid TumorEarly Phase 1NCT05908773

A Microdose Study of TTX-MC138-NODAGA-Cu64 in Subjects With Advanced Solid Tumors

A Early Phase 1 study testing TTX-MC138-NODAGA-Cu64 in people with Advanced Solid Tumor, run by TransCode Therapeutics at 1 site in United States.

Completed

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

Official record
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Trial summary

This is an open-label, single-center, single-arm, phase 0, microdose study in subjects with advanced solid tumors and radiographically confirmed metastases. The study will evaluate delivery of TTX-MC138-NODAGA-Cu64 radiographically and establish the PK and biodistribution of TTX-MC138-NODAGA-Cu64 as determined by… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
TTX-MC138-NODAGA-Cu64
Type of treatment
Injection or infusion
How many people
1 participants
Where
1 siteUnited States
Study dates
4 Apr 2023to 18 Sep 2023
Phase
Early 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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide written informed consent form for the study prior to the performance of any study-specific procedures.
  • Greater than or equal to 18 years of age at the time of screening.
  • Histologically or cytologically confirmed diagnosis of metastatic solid tumor that is not amenable to curative therapy unless participation in the study would delay standard therapy.
  • Eastern Cooperative Oncology Group performance status of 0 to 1.
  • Adequate organ function defined as:
  • Platelet count ≥100 × 109/L with no platelet transfusions in the past 7 days
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  • Absolute neutrophil count ≥1.5 × 109/L
  • Hemoglobin ≥9 g/dL (red blood cell transfusion may be used to reach 9 g/dL but must have been administered at least 1 week prior to the administration of the study drug)
  • Aspartate aminotransferase or alanine aminotransferase <3 × the upper limit of normal (ULN) if no hepatic metastases are present; <5 × ULN if hepatic metastases are present
  • Total bilirubin <1.5 × ULN; <3 × ULN in the presence of Gilbert's disease
  • Estimated (Cockcroft-Gault formula) or measured creatinine clearance ≥50 mL/min
  • At least 1 target lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (at least 10 mm per MRI from fludeoxyglucose [FDG] PET-MRI).
  • Women of childbearing potential must either abstain from sexual intercourse or employ highly effective contraception measures during the study and for at least 30 days after the administration of the study drug. Highly effective measures include 2 forms of contraception. Postmenopausal or surgically sterile women (ie, hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) are eligible. Postmenopausal status is defined as either: amenorrheic for ≥12 months following cessation of exogenous hormonal treatments and without an alternative medical cause; luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal range for women under 50 years of age; radiation-induced ovarian ablation with last menses ≥1 year ago; or chemotherapy-induced menopause with a ≥1-year interval since last menses. Female subjects must refrain from donating or banking eggs (ova, oocytes) and retrieving eggs for use during study treatment and for 30 days after the administration of the study drug.
  • Male subjects, if not surgically sterile, must either abstain from sexual intercourse or employ highly effective contraception (condoms or other barrier forms of contraception) during the study and for at least 30 days after the administration of the study drug. Male subjects should also avoid semen donation or providing semen for in vitro fertilization during the above-mentioned duration.
  • If a clinically indicated MRI is planned, it must be completed at least two weeks prior to or at least two weeks post investigational drug administration.

Who cannot join

  • Unwilling or unable to comply with scheduled visits, study drug administration plan, laboratory tests, or other study procedures and study restrictions.
  • QT interval corrected using Fridericia's formula >480 ms. Subject has a history of prolonged QT syndrome or torsade de pointes. Subject has a familial history of prolonged QT syndrome.
  • Clinically significant, uncontrolled cardiovascular disease including congestive heart failure class III or class IV according to the New York Heart Association classification; myocardial infarction or unstable angina within the previous 6 months; uncontrolled hypertension (Grade 3 or higher); or clinically significant, uncontrolled arrhythmia, including bradyarrhythmias that may cause QT prolongation (eg, type II second-degree heart block or third-degree heart block).
  • Symptomatic central nervous system (CNS) metastases or primary CNS tumor that is associated with progressive neurologic symptoms or requires ongoing corticosteroids to control the CNS disease. Subject must have a stable neurologic status without steroid support for at least 2 weeks before the start of study drug administration. Subjects with stable or asymptomatic CNS metastases or primary CNS are eligible. Brain computed tomography/MRI with or without contrast is mandatory within 4 weeks before the start of study drug administration in case of clinical evidence of brain metastatic disease.
  • Subject who has received anticancer therapy (including both systemic therapy and radiotherapy, but not including immunotherapy or other antibody therapies) within 14 days or 5 half-lives (whichever is shorter) of study drug administration or received antibody therapy within 28 days before the start of study drug administration. The study drug may be started within these washout periods if considered by the investigator to be safe, except on the day of study drug administration.
  • Prior radiation therapy is allowed, provided >14 days have elapsed since completion of radiation prior to enrollment. If target lesions were radiated, they should have progressed prior to the administration of the study drug to be considered target lesions per Response Evaluation Criteria in Solid Tumors version 1.1. If the prior radiation exposure in research studies in the previous 12 months exceeds the current guidelines (ie, 50 mSv/year), the subject will not be enrolled.
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  • Administered a radioisotope within 10 physical half-lives before the start of study drug administration.
  • Subject is unable to undergo or has a contraindication to PET or MRI scan.
  • Subject who has electrical implants such as cardiac pacemaker or perfusion pump
  • Subject who has claustrophobic reactions
  • Body weight over the weight limit for the moving table (>300 lbs for the MRI)
  • Unable to lie comfortably on a bed inside the PET scanner
  • Metallic or electric implants contraindicated for PET-MRI scanning when applicable
  • Subject who has an advanced solid tumor with metastasis to liver only, lymph nodes only, or liver and lymph nodes only.
  • Subject who requires treatment with traditional/herbal medicines or their preparations indicated for tumors or with adjuvant antitumor effects that cannot be discontinued for the day of study drug administration.
  • Subject who received a major surgical procedure within 28 days before the start of study drug administration (procedures such as central venous catheter placement and tumor needle biopsy are not considered major surgical procedures). The study center should discuss other minor surgeries with the sponsor.
  • History of another primary malignancy that has been diagnosed or required therapy within the past year. Note: The following prior malignancies are not exclusionary: completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate or breast cancer, curatively treated localized thyroid cancer, and completely resected carcinoma in situ of any site.
  • Subject is pregnant at the time of screening or on Day 1 before the PET-MRI, as documented by a serum beta human chorionic gonadotropin pregnancy test consistent with pregnancy.
  • Subject is breastfeeding at the time of screening.
  • Known human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus infection that meets the following criteria:
  • Subject with HIV infection is eligible if: documented with undetectable HIV RNA within 4 weeks of study drug administration,
  • No acquired immunodeficiency syndrome defining opportunistic infections within the past 12 months prior to study enrollment, and
  • Is on antiretroviral therapy for at least 4 weeks prior to study enrollment.
  • Presence of any severe or uncontrolled systemic disease or condition, including: (i) uncontrolled hypertension or diabetes; (ii) serious cardiac, pulmonary, or renal conditions; (iii) active bleeding diatheses; (iv) any active type of bacterial, viral, fungal, or other infection that would pose a significant risk to the subject in the opinion of the investigator.
  • Subject who has clinical signs or symptoms consistent with COVID-19 infection or confirmed infection by appropriate laboratory test (done at the discretion of investigator or per local regulation) within the last 2 weeks before the administration of the study drug. In case of confirmed COVID-19 infection before screening, documentation of resolution of infection by appropriate laboratory test is required.
  • Subject who has received or is planning to receive a COVID-19 vaccination within 2 weeks before or after the administration of the study drug. However, COVID-19 vaccinations received >2 weeks before or after the administration of the study drug are permitted.
  • Subject who has received a live or live attenuated vaccines within 30 days before the administration of the study drug.
  • Any unresolved toxicities from prior therapy, greater than CTCAE Grade 1 at the time of starting study treatment, with the exception of alopecia.
  • History of hypersensitivity to active or inactive excipients of the study drug or drugs with a similar chemical structure or class to the study drug, including ferumoxytol (Feraheme).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: An Open-Label, Single-Center, Phase 0, Microdose Study to Demonstrate Delivery of TTX-MC138-NODAGA-Cu64 to Radiographically Confirmed Metastases in Subjects With Advanced Solid Tumors

This is an open-label, single-center, single-arm, phase 0, microdose study in subjects with advanced solid tumors and radiographically confirmed metastases.

The study will evaluate delivery of TTX-MC138-NODAGA-Cu64 radiographically and establish the PK and biodistribution of TTX-MC138-NODAGA-Cu64 as determined by PET-MRI. The study consists of 3 parts: a screening period, dosing period, and follow-up period. The estimated total duration of the study is approximately 46 days.

Approximately 12 subjects with advanced metastatic solid tumors will be enrolled at 1 single site.

Being tested
TTX-MC138-NODAGA-Cu64

What participants receive

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

  • TTX-MC138-NODAGA-Cu64Drug

    TTX-MC138-NODAGA-Cu64 solution was developed as a PET radiopharmaceutical to permit assessment of delivery of TMX-MC138 to metastatic lesions in subjects with solid tumors. Subjects will be administered a microdose of TTX-MC138-NODAGA-Cu64 injection administered intravenously followed by whole body PET imaging.

What is being measured

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

  1. Injected Dose

    Measure the percent injected dose per cubic centimeter (%ID/cc) tissue of TTX-MC138-NODAGA-Cu64 in radiographically confirmed metastatic lesions in subjects with advanced solid tumors using PET-MRI.

    Measured: Throughout study completion for 12 subjects, average 12 months

Timeline

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

  1. First posted18 Jun 2023
  2. Study start4 Apr 2023
  3. Primary completion23 Aug 2023
  4. Study completion18 Sep 2023

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
Early Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05908773
Sponsor's protocol ID
TTX-MC138-NODAGA-Cu64-001
Status last verified
Jan 2025
First submitted
26 May 2023
Last updated
28 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing TTX-MC138-NODAGA-Cu64 in people with Advanced Solid Tumor, run by TransCode Therapeutics 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 15 inclusion and 29 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 Jan 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Injected Dose (time frame: Throughout study completion for 12 subjects, average 12 months). 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 NCT05908773.

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 Jan 2025.

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