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CAL056 mesylate for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by Calgent Biotechnology Co., Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 1 and day 28 of cycle 1, at day 1 of subsequent cycles until cycle 6 (except for cycle 2) (each cycle is 28 days in length)
Awards & highlights

Study Summary

This study is evaluating whether a drug may help treat cancer.

Eligible Conditions
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 1 and day 28 of cycle 1, at day 1 of subsequent cycles until cycle 6 (except for cycle 2) (each cycle is 28 days in length)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 1 and day 28 of cycle 1, at day 1 of subsequent cycles until cycle 6 (except for cycle 2) (each cycle is 28 days in length) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determination of tolerability and maximum tolerated dose (MTD) of CAL056 mesylate by DLTs using NCI CTCAE version 5.0
Evaluation of the PK profile of CAL056 mesylate: Apparent terminal elimination half-life (t½)
Evaluation of the PK profile of CAL056 mesylate: Area under the concentration-time curve (AUC)
+5 more
Secondary outcome measures
Neoplasms

Trial Design

5Treatment groups
Experimental Treatment
Group I: Cohort 5: 160 mg CAL056 mesylateExperimental Treatment1 Intervention
Patients will receive oral dose of 160 mg CAL056 mesylate once daily under fasting condition in the morning for 28 days during each cycle.
Group II: Cohort 4: 120 mg CAL056 mesylateExperimental Treatment1 Intervention
Patients will receive oral dose of 120 mg CAL056 mesylate once daily under fasting condition in the morning for 28 days during each cycle.
Group III: Cohort 3: 80 mg CAL056 mesylateExperimental Treatment1 Intervention
Patients will receive oral dose of 80 mg CAL056 mesylate once daily under fasting condition in the morning for 28 days during each cycle.
Group IV: Cohort 2: 40 mg CAL056 mesylateExperimental Treatment1 Intervention
Patients will receive oral dose of 40 mg CAL056 mesylate once daily under fasting condition in the morning for 28 days during each cycle.
Group V: Cohort 1: 20 mg CAL056 mesylateExperimental Treatment1 Intervention
Patients will receive oral dose of 20 mg CAL056 mesylate once daily under fasting condition in the morning for 28 days during each cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CAL056 mesylate
2020
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Calgent Biotechnology Co., LtdLead Sponsor
Yun Yen, M.D.Study ChairCalgent Biotechnology Co., Ltd

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, and Pharmacokinetics of CAL056 Mesylate in Patients With Resistant or Refractory Solid Tumors
2020. "Safety, Tolerability, and Pharmacokinetics of CAL056 Mesylate in Patients With Resistant or Refractory Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04686383.
~4 spots leftby Apr 2025
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