NCT05666635

Study of LTC004 in Subjects With Advanced Malignant Tumors

A Phase I Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LTC004 in Patients With Advanced or Metastatic Malignancies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 368 (estimated)
• Sponsor: Letolab · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This was a multicenter, open, multi-cohort PHASE I study, consisting of 2 phases: Phase Ia (Phase Ia dose escalation) and Phase Ib (Phase Ib multi-cohort expansion). The objective of this study was to evaluate safety, tolerability, pharmacokinetic， Pharmacodynamics and biological characteristics, and initial efficacy in advanced malignant tumors.

Detailed description

Phase I dose escalation phase：This study predicted a total of 8 dose groups, 3, 15, 45, 90, 180，270，360 and 450 ug/kg. Phase Ib expansion phase: This phase is the multi-cohort indication expansion phase. Based on the data obtained in phase I, chose an appropriate dose continue to explore multi-cohort indications.

Conditions

• Adult Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	LTC004	LTC004 Phase I:Participants will be allocated to one of the following dose groups: 3, 15, 45, 90, 180，270,360 and 450 ug/kg, and receive a treatment of LTC004 followed by 21 days of dose limited toxicity (DLT) observation period. Phase Ib indication exploration Other Name: LTC004 for Injection

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2022-12-28
• Last updated: 2022-12-28