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Dose-Escalation and Dose-Expansion Study of ZX-4081 in Patients With Advanced Solid Tumors

NCT05118841 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-02-02

No results posted yet for this study

Summary

A Phase 1, first-in-human, open-label, multicenter, dose escalation and dose expansion study to investigate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of ZX-4081 administered orally (PO) twice daily (BID) in 28-day cycles in patients with Advanced Solid Tumors.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

ZX-4081

Twice daily (BID), oral dosing of ZX-4081 at the assigned dose level in a 28-day cycle

Sponsors & Collaborators

  • Nanjing Zenshine Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-03
Primary Completion
2023-05-31
Completion
2024-05-31
FDA Drug
Yes

Countries

  • United States

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 NCT05118841 on ClinicalTrials.gov