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Study of LTC004 in Subjects With Advanced Malignant Tumors

NCT05666635 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 368

Last updated 2022-12-28

No results posted yet for this study

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.

Conditions

  • Adult Solid Tumor

Interventions

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

Sponsors & Collaborators

  • Letolab

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-12-31
Primary Completion
2024-12-31
Completion
2024-12-31

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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 NCT05666635 on ClinicalTrials.gov