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NOT YET RECRUITING
NCT06277804
PHASE1

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

Sponsor: Letolab

View on ClinicalTrials.gov

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.

Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LTC004 in Combination With Cyclophosphamide and Fludarabine in Patients With Advanced or Metastatic Malignancies Tumor

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2024-03-01

Completion Date

2027-07-01

Last Updated

2024-02-26

Healthy Volunteers

No

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in combination with fludarabine (25 mg/m2) was given on days 3 and 4 of each cycle, Q3W, until disease progression, withdrawn informed or intolerable