Resistant or Refractory Solid TumorsPhase 1NCT04686383
Safety, Tolerability, and Pharmacokinetics of CAL056 Mesylate in Patients With Resistant or Refractory Solid Tumors
A Phase 1 study testing CAL056 mesylate in people with Resistant or Refractory Solid Tumors, run by Calgent Biotechnology Co., Ltd at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resistant or Refractory Solid Tumors
- What is being tested?
- CAL056 mesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 29 Dec 2020to 30 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
NEXT Oncology, 2829 Babcock Road Suite 300
San Antonio, Texas, 78229
About this study
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
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.
Read the 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.
- Conditions
- Resistant or Refractory Solid Tumors
- Being tested
- CAL056 mesylate
- Keywords
- CAL056 mesylate, Oncology, Dose-limiting toxicity, Maximum tolerated dose, Pharmacokinetics, Safety
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAL056 mesylateDrug
Dosage form: 20 mg CAL056 mesylate/tablet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CAL056 mesylate |
| 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. Receives: Drug: CAL056 mesylate |
| 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. Receives: Drug: CAL056 mesylate |
| 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. Receives: Drug: CAL056 mesylate |
| 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. Receives: Drug: CAL056 mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
Pharmacokinetics profile will be evaluated following comprehensive PK parameter, such as t½.
Measured: 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.
Measured: 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.
Measured: Cycle 1 (28 days)
Secondary outcomes (1)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start29 Dec 2020
- Primary completion7 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant or Refractory Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calgent Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yun Yen, M.D., Study chair, Calgent Biotechnology Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686383
- Sponsor's protocol ID
- CAL056-101
- Status last verified
- Apr 2023
- First submitted
- 15 Dec 2020
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04686383
- Acronym / sponsor ID
- CAL056-101
- Conditions
- Resistant or Refractory Solid Tumors
- Keywords
- CAL056 mesylate, Oncology, Dose-limiting toxicity, Maximum tolerated dose, Pharmacokinetics, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Calgent Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Dec 2020 (actual)
- Primary completion
- 7 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 20 mg CAL056 mesylate | Experimental | Drug: CAL056 mesylatePatients 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 | Drug: CAL056 mesylatePatients 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 | Drug: CAL056 mesylatePatients 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 | Drug: CAL056 mesylatePatients 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 | Drug: CAL056 mesylatePatients will receive oral dose of 160 mg CAL056 mesylate once daily under fasting condition in the morning for 28 days during each cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAL056 mesylateDosage form: 20 mg CAL056 mesylate/tablet | Drug | Cohort 1: 20 mg CAL056 mesylate, Cohort 2: 40 mg CAL056 mesylate, Cohort 3: 80 mg CAL056 mesylate, Cohort 4: 120 mg CAL056 mesylate, Cohort 5: 160 mg CAL056 mesylate |
Primary outcome
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)
To evaluate the safety and tolerability of CAL056 mesylate in cancer patients.
Number of patients with AEs qualified as dose-limiting toxicities (DLTs)
Time frame: Cycle 1 (28 days)
Dose-limiting toxicities are evaluated using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Determination of tolerability and maximum tolerated dose (MTD) of CAL056 mesylate by DLTs using NCI CTCAE version 5.0
Time frame: Cycle 1 (28 days)
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).
Evaluation of the PK profile of CAL056 mesylate: Maximum observed concentration (Cmax)
Time frame: 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)
Pharmacokinetics profile will be evaluated following a comprehensive PK parameter, such as Cmax.
Evaluation of the PK profile of CAL056 mesylate: Time to reach Cmax (Tmax)
Time frame: 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)
Pharmacokinetics profile will be evaluated following comprehensive PK parameter, such as Tmax.
Evaluation of the PK profile of CAL056 mesylate: Apparent terminal elimination half-life (t½)
Time frame: 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)
Pharmacokinetics profile will be evaluated following comprehensive PK parameter, such as t½.
Evaluation of the PK profile of CAL056 mesylate: Area under the concentration-time curve (AUC)
Time frame: 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)
Pharmacokinetics profile will be evaluated following a comprehensive PK parameter, AUC.
Preliminary determination of the recommended phase II dose (RP2D) of CAL056 mesylate
Time frame: Cycle 1 (28 days)
The RP2D will be preliminarily determined by the PK profile, type and severity of drug related toxicity, clinical suitability for long-term administration.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun Yen, M.D. study chair
Calgent Biotechnology Co., Ltd
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAL056 mesylate in people with Resistant or Refractory Solid Tumors, run by Calgent Biotechnology Co., Ltd at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.