Advanced Solid TumorsPhase 1NCT05072522
A Study of SKLB1028 in Patients With Advanced Solid Tumor
A Phase 1 study testing SKLB1028 in people with Advanced Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SKLB1028 in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- SKLB1028
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- Oct 2021to Oct 2023
- 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 volunteered to participate in this study and signed the informed consent form.
- Age ≥18, no gender limitation.
- Patients with malignant solid tumor who have failed or could not tolerate standard treatment and for whom no standard treatment is available.
- Recurrent or metastatic solid tumors confirmed by histology; patients who are judged by the investigator to be suitable for treatment with SKLB1028 capsules and who meet the requirements of tumor type for corresponding stages:
- Stage I: no restriction on solid tumor types;
- Phase II: solid tumor type determined by the investigator and the sponsor based on the results of phase I.
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- Stage 1: At least one unmeasurable lesion; Stage 2: At least one measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Patient must meet the following criteria as indicated on the clinical laboratory tests:
- Absolute neutrophil count ≥1.5×10^9 /L; platelet count ≥80×10^9 /L; hemoglobin ≥90 g/L;
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN);
- Total bilirubin ≤ 1.5 × ULN, (≤ 3 × ULN for patients with liver metastasis or liver cancer); Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (≤ 5 × ULN for patients with liver metastasis or liver cancer).
- Patient is suitable for oral administration of the study drug.
- Female patients should agree to use contraceptive measures (such as IUD, condom, etc.) during the study period and within 6 months after the end of the study; negative serum pregnancy test within 7 days prior to enrollment and must be non-lactating patients; male patients should agree to use contraceptive measures during the study period and within 6 months after the end of the study period.
Who cannot join
- The patient have a previous history of severe allergy to drugs and food.
- Expected survival < 3 months.
- Other malignant active tumors within the past 3 years; except for cured locally curable cancers, such as basal or squamous cell skin carcinoma, or in situ prostate, cervical or breast cancer.
- Central nervous system metastasis (excluding brain metastasis with stable symptoms after local treatment)
- Patients with hepatitis B (HBsAg positive or HBcAb positive with HBV DNA higher than the upper limit of the normal value of the research center) or hepatitis C (HCV antibody positive with HCV RNA higher than the upper limit of the normal value of the research center) or HIV antibody positive.
- Patients whose toxicity of previous anti-tumor treatment has not recovered to ≤ grade 1.
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- Cardiac dysfunction, including:
- QTc interval female ≥ 470 ms, male ≥ 450 ms; Complete left bundle branch block, grade II or III atrioventricular block; Poorly controlled malignant arrhythmias; Cardiac valve regurgitation or stenosis requiring treatment; Cardiac ejection fraction less than 50% within 6 months before screening; Myocardial infarction, unstable angina pectoris, severe pericardial disease, severe myocardial disease occurred within 6 months before screening; History of chronic congestive heart failure with NYHA ≥ grade 3.
- Patients have poorly controlled hypertension.
- Patients have thrombotic or embolic events such as cerebrovascular accident, pulmonary embolism, etc within 6 months before screening.
- Patients who have received any antitumor treatment within 4 weeks before the first administration; those who have received herbal or proprietary Chinese medicines with a clear antineoplastic indication 2 weeks prior to the first administration.
- Patients have received other unlisted clinical study drugs within 4 weeks before the first administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Multicenter, Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SKLB1028 in Patients With Advanced Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SKLB1028 in patients with advanced solid tumors.
Read the detailed description
This study is divided into two stages. The first stage is the dose-escalation stage to evaluate the safety, tolerance and pharmacokinetics of SKLB1028 in patients with advanced solid tumors. A classic 3+3 design will be used to determine the maximum tolerated dose (MTD). Patients with advanced solid tumors will receive SKLB1028 orally once daily (QD) in continuous 28-day cycles, starting at a dose of 200 mg and rising to 400 mg. The second stage is cohort-expansion study. The safe tolerated dose group will be selected for case expansion. At this stage, patients with advanced solid tumors with better response on SKLB1028 are mainly enrolled.
- Conditions
- Advanced Solid Tumors
- Being tested
- SKLB1028
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKLB1028Drug
SKLB1028 capsules, oral, once daily in continuous 28-day cycles
| Study group | Role | What they receive |
|---|---|---|
| SKLB1028 | Experimental | Dose-escalation stage: Patients will receive SKLB1028 capsules orally once daily (QD) in continuous 28-day cycles, in three doses beginning at 200 mg and rising to 400 mg.
Cohort-expansion stage: Patients will receive SKLB1028 capsules orally once daily (QD) in continuous 28-day cycles at selected dose as per the results of dose-escalation stage. Receives: Drug: SKLB1028 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
To identify the dose-limited toxicity (DLT).
Measured: At the end of Cycle 1 (each cycle is 28 days)
Maximum tolerated dose (MTD)
To identify the maximum tolerated dose (MTD）
Measured: At the end of Cycle 1 (each cycle is 28 days)
Treatment Emergent Adverse Event (TEAE)
TEAE is defined as an adverse event that occurs during treatment
Measured: From the initiation of the first dose to 28 days after the last dose
Secondary outcomes (7)
Pharmacokinetic indexes, Cmax
Maximum concentration (Cmax) of SKLB1028
Measured: At the end of Cycle 1 (each cycle is 28 days)
Pharmacokinetic indexes, Tmax Pharmacokinetic indexes, Tmax
Time to Cmax (Tmax) of SKLB1028
Measured: At the end of Cycle 1 (each cycle is 28 days)
Pharmacokinetic indexes, AUC0-t
Area under the concentration-time curve (AUC) from 0 to the last measurable concentration (AUC0-t) of SKLB1028
Measured: At the end of Cycle 1 (each cycle is 28 days)
Overall response rate (ORR)
ORR is defined as the proportion of patients who have a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Measured: Up to approximately 2 years
Progression-free survival (PFS)
PFS is defined as the time from the date of first dose until the date of first documented PD as per RECIST 1.1 or death from any cause, whichever occurs first
Measured: Up to approximately 2 years
Disease control rate (DCR)
DCR is defined as the proportion of patients who have a response of CR/PR or stable disease (SD) as per RECIST 1.1
Measured: Up to approximately 2 years
Duration of response (DOR)
DoR is defined as the time from the first assessment of CR or PR until the date of first occurrence of progressive disease (PD) as per RECIST 1.1 or death from any cause, whichever occurs first
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suxia Luo, Master, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072522
- Sponsor's protocol ID
- HA114-CSP-012
- Status last verified
- Sep 2021
- First submitted
- 26 Sep 2021
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SKLB1028 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05072522
- Acronym / sponsor ID
- HA114-CSP-012
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2021 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 11 Oct 2021 (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.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of SKLB1028 in patients with advanced solid tumors.
Detailed description
This study is divided into two stages. The first stage is the dose-escalation stage to evaluate the safety, tolerance and pharmacokinetics of SKLB1028 in patients with advanced solid tumors. A classic 3+3 design will be used to determine the maximum tolerated dose (MTD). Patients with advanced solid tumors will receive SKLB1028 orally once daily (QD) in continuous 28-day cycles, starting at a dose of 200 mg and rising to 400 mg. The second stage is cohort-expansion study. The safe tolerated dose group will be selected for case expansion. At this stage, patients with advanced solid tumors with better response on SKLB1028 are mainly enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SKLB1028 | Experimental | Drug: SKLB1028Dose-escalation stage: Patients will receive SKLB1028 capsules orally once daily (QD) in continuous 28-day cycles, in three doses beginning at 200 mg and rising to 400 mg. Cohort-expansion stage: Patients will receive SKLB1028 capsules orally once daily (QD) in continuous 28-day cycles at selected dose as per the results of dose-escalation stage. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients volunteered to participate in this study and signed the informed consent form.
- Age ≥18, no gender limitation.
- Patients with malignant solid tumor who have failed or could not tolerate standard treatment and for whom no standard treatment is available.
- Recurrent or metastatic solid tumors confirmed by histology; patients who are judged by the investigator to be suitable for treatment with SKLB1028 capsules and who meet the requirements of tumor type for corresponding stages:
- Stage 1: At least one unmeasurable lesion; Stage 2: At least one measurable lesion according to RECIST v1.1.
Key exclusion criteria (12 listed)
- The patient have a previous history of severe allergy to drugs and food.
- Expected survival < 3 months.
- Other malignant active tumors within the past 3 years; except for cured locally curable cancers, such as basal or squamous cell skin carcinoma, or in situ prostate, cervical or breast cancer.
- Central nervous system metastasis (excluding brain metastasis with stable symptoms after local treatment)
- Patients with hepatitis B (HBsAg positive or HBcAb positive with HBV DNA higher than the upper limit of the normal value of the research center) or hepatitis C (HCV antibody positive with HCV RNA higher than the upper limit of the normal value of the research center) or HIV antibody positive.
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 |
|---|---|---|
| SKLB1028SKLB1028 capsules, oral, once daily in continuous 28-day cycles | Drug | SKLB1028 |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
To identify the dose-limited toxicity (DLT).
Maximum tolerated dose (MTD)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
To identify the maximum tolerated dose (MTD）
Treatment Emergent Adverse Event (TEAE)
Time frame: From the initiation of the first dose to 28 days after the last dose
TEAE is defined as an adverse event that occurs during treatment
7 secondary outcomes
Pharmacokinetic indexes, Cmax
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Pharmacokinetic indexes, Tmax Pharmacokinetic indexes, Tmax
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Pharmacokinetic indexes, AUC0-t
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Overall response rate (ORR)
Time frame: Up to approximately 2 years
Progression-free survival (PFS)
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Duration of response (DOR)
Time frame: Up to approximately 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Suxia Luo, Master principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SKLB1028 in people with Advanced Solid Tumors, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
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 14 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuefang Xia (+86-010-63932012, xiaxuefang@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 3 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 11 Oct 2021.