Spots Global Cancer Trial Database for Safety, Tolerability, and Pharmacokinetics of CAL056 Mesylate in Patients With Resistant or Refractory Solid Tumors

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Trial Identification

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

Official Title: A Phase I, Multi-center, Open-label, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CAL056 Mesylate in Patients With Solid Tumors Resistant or Refractory to Standard Treatments

Study ID: NCT04686383

Conditions

Resistant or Refractory Solid Tumors

Interventions

CAL056 mesylate

Study Description

Brief 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.

Detailed Description: Patients with resistant or refractory malignant solid tumors and no standard treatment available will be screened for the eligibility. Patients will be screened within 28 days prior to the first dose of CAL056 mesylate. Eligible patients will receive CAL056 mesylate daily with the assigned dose level for 28 days (Day 1 to Day 28) for each treatment cycle. Patients will be administered with CAL056 mesylate at clinical site at scheduled visits (i.e. Day 1/Visit 1, Day 8/Visit 2, Day 15/ Visit 3, Day 22/Visit 4, Day 28/Visit 5). Remaining doses of CAL056 mesylate on all other days will be self-administered by patients at home. After the administration of CAL056 mesylate on Day 1 and Day 28, patients can stay at the clinical site for 24 hours to have safety monitoring and blood samples collected for PK analysis. Only patients completing Cycle 1 without a dose-limiting toxicity (DLT) or disease progression will be allowed to continue the subsequent cycles at the same dose level. The maximum number of dosing cycle is 6 cycles in each patient in this study. Continuation of using CAL056 mesylate may be permitted after the evaluation of the risk/benefit in individual patient by the Investigators and with the approval of Calgent. During the Cycle 1 of study period, a total of 5 visits are scheduled to evaluate the safety, PK, preliminary efficacy, and pharmacodynamics of CAL056 mesylate. Each visit is planned on Day 1 of each subsequent cycle if patients continue the treatment of CAL056 mesylate. After the end treatment of CAL056 mesylate, an end of treatment (EOT) visit and a safety follow-up visit will be scheduled.