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TR64 in Patients With Advanced Solid Tumors

NCT05649345 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-05-14

No results posted yet for this study

Summary

This is a open-label, dose escalation, accelerated titration combined 3+3 design, phase I study, to evaluate the safety and tolerability, and to determine the RP2D of TR64 when administered qd in patients with advanced solid tumors. Up to 6 cohorts of 1-6 or 3-6 patients each will be treated in the study.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

TR64

TR64 tablets will be given daily for 28 days in 28-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons.

Sponsors & Collaborators

  • Tarapeutics Science Inc.

    lead INDUSTRY

Principal Investigators

  • Huan Zhou, PhD · The First Affiliated Hospital of Bengbu Medical University

  • Funan Liu, MD, PhD · First Hospital of China Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-01-12
Primary Completion
2026-08-30
Completion
2026-12-30

Countries

  • China

Study Locations

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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 NCT05649345 on ClinicalTrials.gov