TheranosticTrials.org

Clinical Trial · NCT05908773

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

Overview

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.

Sponsor

TerSera Therapeutics

Phase

Early Phase 1

ClinicalTrials.gov

NCT05908773

Drug / Compound

TTX-MC138

Isotope(s):
Target(s):
  • microRNA-10b
Ligand Class: Small Molecules
Chelator: NODAGA

Eligibility

Inclusion

  • Estimated (Cockcroft-Gault formula) or measured creatinine clearance ≥50 mL/min
  • Adequate organ function defined as:
  • 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)
  • 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).
  • Platelet count ≥100 × 109/L with no platelet transfusions in the past 7 days
  • Eastern Cooperative Oncology Group performance status of 0 to 1.
  • 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.
  • Absolute neutrophil count ≥1.5 × 109/L

Exclusion

  • 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.
  • Subject is unable to undergo or has a contraindication to PET or MRI scan.
  • 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 electrical implants such as cardiac pacemaker or perfusion pump
  • 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.