Description:
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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
CAL056-101
- NCT ID:
NCT04686383
Conditions
- Resistant or Refractory Solid Tumors
Interventions
| Drug | Synonyms | Arms |
|---|
| CAL056 mesylate | | Cohort 1: 20 mg CAL056 mesylate |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| 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. | |
| 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. | |
| 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. | |
| 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. | |
| 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. | |
Eligibility Criteria
Inclusion Criteria:
- Patients with age ≥ 18 years old
- Patients with resistant or refractory solid tumors confirmed by histology which are
unresponsive to standard therapies
- Patients with at least one measurable lesion per RECIST version 1.1.
- Patients with Eastern Cooperative Oncology Group performance status (ECOG-PS) ≤ 2
- Patients with at least 3 months of life expectancy as judged by the investigators
- Patients with adequate bone marrow reserve and organ function
- Patients with the negative result for testing Severe Acute Respiratory Syndrome
Coronavirus 2 (SARS-CoV-2)
- Female patients are eligible to participate if they are of non-childbearing potential
or have documentation of a negative serum pregnancy test at screening. Sexually active
pre-menopausal women of childbearing potential must agree to use adequate, highly
effective contraceptive measures during and upon completion of the study and for at
least 6 months after the last dose of study drug
- Male patients who agree to use an adequate method of contraception during and upon
completion of the study and for at least 6 months after the last dose of study drug
- Patients must be willing and be able to provide written informed consent for the
study.
Exclusion Criteria:
- History of other invasive malignancy that is currently active and/or has been treated
within 12 months prior to screening
- Patients with the presence of symptomatic central nervous system (CNS) metastases
requiring radiation treatment, surgery, or continuous use of corticosteroids or
patients with untreated or developing brain metastasis causing any symptoms, such as
neurologic deficits, seizures, or headache
- Any prior adjuvant cytotoxic chemotherapy within 4 weeks prior to screening
- Any radiotherapy within 2 weeks prior to screening
- Pre-existing chemotherapy-related peripheral neuropathy
- Currently participating or has participated in a study of an investigational product
within 4 weeks prior to the first dose of CAL056 mesylate
- Patients with history of organ or stem cell transplant requiring immunosuppressive
medications
- Active autoimmune disease
- Pulmonary conditions such as sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or
hypersensitivity pneumonitis
- Patients who have chronic obstructive pulmonary disease (COPD) or asthma
- Has a history of pneumonitis that required steroids or current pneumonitis
- Known significant liver disease
- Known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies)
- Has received live attenuated vaccination within 30 days prior to the first dose of
CAL056 mesylate
- Female patients who is pregnant, breast-feeding, or planning to become pregnant
- Patients with corrected QT interval (QTc) interval of > 450 msec.
- Has history of clinically significant or severe gastrointestinal disease or condition
that may affect drug absorption within the past 3 months.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Number of patients with adverse events (AEs), serious adverse events (SAEs), and treatment emergent adverse events (TEAEs) |
| Time Frame: | 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) |
| Safety Issue: | |
| Description: | To evaluate the safety and tolerability of CAL056 mesylate in cancer patients. |
Secondary Outcome Measures
| Measure: | Evaluation of the preliminary efficacy of CAL056 mesylate in tumor response as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 |
| Time Frame: | 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) |
| Safety Issue: | |
| Description: | Tumor response will be assessed by RECIST version 1.1. |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Calgent Biotechnology Co., Ltd |
Trial Keywords
- CAL056 mesylate
- Oncology
- Dose-limiting toxicity
- Maximum tolerated dose
- Pharmacokinetics
- Safety
Last Updated
June 11, 2021
