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FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients With Select Solid Tumors (FRONTIER)

NCT05432193 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-06-25

No results posted yet for this study

Summary

This Phase 1 study will evaluate the safety and tolerability of \[Ga-68\]-PNT6555 and \[Lu-177\]-PNT6555 in subjects with select solid tumors that have FAP over-expression, in order to determine a recommended Phase 2 dose.

Conditions

Interventions

DRUG

[Ga-68]-PNT6555

\[Ga-68\]-PNT6555 IV administered as imaging agent for PET/CT

DRUG

[Lu-177]-PNT6555

Patients with FAP-avid disease as determined by the \[Ga-68\]-PNT6555 screening PET/CT will receive \[Lu-177\]-PNT6555 at a fixed dose level for up to 6 doses at an interval of 6 weeks between each dose.

Sponsors & Collaborators

  • POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company

    lead INDUSTRY

Principal Investigators

  • Jessica Jensen · Eli Lilly and Company

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-13
Primary Completion
2023-11-10
Completion
2024-10-02
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05432193 on ClinicalTrials.gov