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Phase II Clinical Study of LTC004 in Patients With Advanced Sarcoma

NCT06384248 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-04-25

No results posted yet for this study

Summary

This is a phase II clinical study to evaluate the safety, tolerability and preliminary antitumor activity of LTC004 in patients with locally advanced or metastatic sarcoma；Enrollment of 10 evaluable subjects in Phase I. If ≥2 subjects experience objective remission or SD lasting \>12 weeks, proceed to Phase II to enroll an additional 20 evaluable subjects to further evaluation of the safety and efficacy of LTC004

Conditions

  • Unresectable or Metastatic Sarcoma

Interventions

DRUG

LTC004

LTC004,45μg/kg,IV,Day 1,Q3W;

Sponsors & Collaborators

  • Letolab

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-26
Primary Completion
2025-12-28
Completion
2025-12-28

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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 NCT06384248 on ClinicalTrials.gov