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A Phase I Study of LTC004 Combin With FC in Patients With Advanced/Metastatic Malignancies Tumor

NCT06277804 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-02-26

No results posted yet for this study

Summary

This was a multicenter, open PHASE I study of LTC004 in Combination With Cyclophosphamide and Fludarabine in Patients With Advanced/Metastatic Malignancies Tumor, the study design consisting of 2 phases: Phase Ia (Phase Ia dose escalation) and Phase Ib (Phase Ib expansion). The objective of this study was to evaluate combination safety, tolerability, pharmacokinetic,pharmacodynamics characteristics, and initial efficacy in advanced malignant tumors.

Conditions

  • Adult Solid Tumor

Interventions

DRUG

LTC004 in Combination With Cyclophosphamide and Fludarabine

LTC004 was given on day 1 and cyclophosphamide (250 mg/m2) in combination with fludarabine (25 mg/m2) was given on days 3 and 4 of each cycle, Q3W, until disease progression, withdrawn informed or intolerable

Sponsors & Collaborators

  • Letolab

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2027-07-01
Completion
2027-07-01

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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 NCT06277804 on ClinicalTrials.gov