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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: 20 mg CAL056 mesylate | Experimental | Patients will receive oral dose of 20 mg CAL056 mesylate once daily under fasting condition in the morning for 28 days during each cycle. |
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| Cohort 2: 40 mg CAL056 mesylate | Experimental | Patients will receive oral dose of 40 mg CAL056 mesylate once daily under fasting condition in the morning for 28 days during each cycle. |
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| Cohort 3: 80 mg CAL056 mesylate | Experimental | Patients will receive oral dose of 80 mg CAL056 mesylate once daily under fasting condition in the morning for 28 days during each cycle. |
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| Cohort 4: 120 mg CAL056 mesylate | Experimental | Patients will receive oral dose of 120 mg CAL056 mesylate once daily under fasting condition in the morning for 28 days during each cycle. |
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| Cohort 5: 160 mg CAL056 mesylate | Experimental | Patients will receive oral dose of 160 mg CAL056 mesylate once daily under fasting condition in the morning for 28 days during each cycle. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAL056 mesylate | Drug | Dosage form: 20 mg CAL056 mesylate/tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events (AEs), serious adverse events (SAEs), and treatment emergent adverse events (TEAEs) | To evaluate the safety and tolerability of CAL056 mesylate in cancer patients. | From screening visit until safety follow-up visit (at 28 days after the EOT) or before starting new anticancer treatment, whichever comes first (up to 1-year) |
| Number of patients with AEs qualified as dose-limiting toxicities (DLTs) | Dose-limiting toxicities are evaluated using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | Cycle 1 (28 days) |
| Determination of tolerability and maximum tolerated dose (MTD) of CAL056 mesylate by DLTs using NCI CTCAE version 5.0 | MTD will be the highest dose associated with occurrence of DLTs ≤ 33% (e.g. 2/6 evaluable patients experience a DLT during the first treatment Cycle). | Cycle 1 (28 days) |
| Evaluation of the PK profile of CAL056 mesylate: Maximum observed concentration (Cmax) | Pharmacokinetics profile will be evaluated following a comprehensive PK parameter, such as Cmax. | 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) |
| Evaluation of the PK profile of CAL056 mesylate: Time to reach Cmax (Tmax) | Pharmacokinetics profile will be evaluated following comprehensive PK parameter, such as Tmax. | 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) |
| Evaluation of the PK profile of CAL056 mesylate: Apparent terminal elimination half-life (t½) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the preliminary efficacy of CAL056 mesylate in tumor response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 | Tumor response will be assessed by RECIST version 1.1. | At the screening visit and within 7 days prior to Day 1 of odd cycles (i.e., Cycle 3 and Cycle 5) (each cycle is 28 days in length) and at EOT/Early Termination (ET) (up to 21 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yun Yen, M.D. | Calgent Biotechnology Co., Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States | ||
| NEXT Oncology, 2829 Babcock Road Suite 300 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Pharmacokinetics profile will be evaluated following comprehensive PK parameter, such as t½. |
| 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) |
| Evaluation of the PK profile of CAL056 mesylate: Area under the concentration-time curve (AUC) | Pharmacokinetics profile will be evaluated following a comprehensive PK parameter, AUC. | 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) |
| Preliminary determination of the recommended phase II dose (RP2D) of CAL056 mesylate | The RP2D will be preliminarily determined by the PK profile, type and severity of drug related toxicity, clinical suitability for long-term administration. | Cycle 1 (28 days) |
| San Antonio |
| Texas |
| 78229 |
| United States |
| Tzu Chi General Hospital, Taipei Branch | New Taipei City | Taiwan |