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Safety, Tolerability, and Pharmacokinetics of CAL056 Mesylate in Patients With Resistant or Refractory Solid Tumors

NCT04686383 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2023-04-25

No results posted yet for this study

Summary

This is a multi-center, open-label, dose-escalation, phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), preliminary efficacy, and pharmacodynamics of CAL056 mesylate in cancer patients with resistant or refractory solid tumors.

Conditions

  • Resistant or Refractory Solid Tumors

Interventions

DRUG

CAL056 mesylate

Dosage form: 20 mg CAL056 mesylate/tablet

Sponsors & Collaborators

  • Calgent Biotechnology Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Yun Yen, M.D. · Calgent Biotechnology Co., Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-29
Primary Completion
2022-06-07
Completion
2022-06-30
FDA Drug
Yes

Countries

  • United States
  • Taiwan

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 NCT04686383 on ClinicalTrials.gov