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

NCT05908773 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: TTX-MC138-NODAGA-Cu64-001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (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.

  Throughout study completion for 12 subjects, average 12 months

Interventions

TTX-MC138-NODAGA-Cu64 DRUG

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• TransCode Therapeutics: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 18, 2023
• Study Start: April 4, 2023
• Primary Completion: August 23, 2023
• Study Completion: September 18, 2023
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

US (1)