Basal Cell CarcinomaPhase 1NCT03734913
A Phase 1 Study of ZSP1602 in Participants With Advanced Solid Tumors
A Phase 1 study testing ZSP1602 in people with Basal Cell Carcinoma and Medulloblastoma, run by Guangdong Zhongsheng Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics, and determine the maximum tolerated dose of ZSP1602 in participants with basal cell carcinoma, adenocarcinoma of esophagogastric junction, small cell lung cancer, neuroendocrine neoplasm and other advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Basal Cell Carcinoma, Medulloblastoma, Adenocarcinoma of Esophagogastric Junction
- What is being tested?
- ZSP1602
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 25 Jan 2019to 31 Jul 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants are required to meet all the criteria below in order to be included in the trial:
- Male or female participants, aged 18 ~ 75 years.
- Confirmed diagnosis of advanced solid tumors by histological or cytological examination, Participants have no effective standard anticancer therapy available or is intolerant to standard anticancer therapy. For Part 1 Dose Ascending Stage, and Part 2 Dose expansion Stage:
- For Part 1: Advanced solid tumors including basal cell carcinoma and medulloblastoma, regardless of SMO or Gli1 alteration status.
- For Part 2: Participants will be enrolled into cohort A and cohort B. Cohort A: Participants with Adenocarcinoma of Esophagogastric Junction with SMO or Gli1 protein overexpression alteration. (IHC≥1%) Cohort B: Participants with basal cell carcinoma, small cell lung cancer, neuroendocrine neoplasm and glioblastoma with SMO or Gli1 protein overexpression alteration. (IHC≥1%)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
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- Participants with at least 1 measurable tumor lesion based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1) and response assessment in neuro-oncology criteria (RANO) (participants with glioblastoma must accept skull MRI scanning.)
- Recovery from past medical history of adverse reactions (excluding alopecia and neurotoxicity) caused by radiotherapy and chemotherapy to national cancer institute common terminology criteria for adverse events 4.03 (NCI CTCAE 4.03) ≤Grade 1 or baseline level.
- Life expectancy > 12 weeks.
- Adequate organ function, defined by the following laboratory results, to be obtained prior to registration and enrollment:
- Bone marrow function: absolute neutrophil count (ANC)≥1.5×10^9/L; hemoglobin (HB)≥90 g/L; Platelet count (PLT)≥75×10^9/L.
- Liver function: Alanine aminotransferase (ALT)≤2.5×the upper limit of normal (ULN), aspartate aminotransferase (AST)≤2.5×ULN, alkaline phosphatase (ALP)≤2.5×ULN, total bilirubin (TBIL)≤1.5×ULN; ALT≤5×ULN, AST≤5×ULN, ALP≤5×ULN (For participants with liver metastasis).
- Renal function: creatinine≤1.5×ULN; clearance (CL)≥ 60 mL/min. Coagulation function: international normalized ratio (INR)≤1.5×ULN, activated partial thromboplastin time (APTT)≤1.5×ULN.
- Left ventricular ejection fractions (LVEF)≥50%. Creatine kinase (CK)≤2.5×ULN.
- Participants (including partners) have no gestation plans and must use reliable methods of contraception during the study and until 8 months following the last dose of investigational product.
- Participants must provide a written dated Informed Consent Form (ICF) with signature prior to screening.
- Participants must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
Who cannot join
- Eligible participants must not meet any of the following exclusion criteria:
- Participants who have intracranial tumor and/or brain metastases with clinical symptoms and need treatment are ineligible except for the following circumstances:
- recovery from the therapy (including radiotherapy and/or surgery) 4 weeks before enrollment.
- Participants with intracranial tumor who are clinically stable during screening and enrollment, have no need to medication by hormone or anticonvulsants, and are estimated to be clinically stable during the study.
- Participants with glioblastoma confirmed diagnosis via MRI or CT of intracranial hemorrhage and intratumor hemorrhage.
- Participants with positive human immunodeficiency virus(HIV) or hepatitis C virus antibody (HCV) or hepatitis B surface antigen (HBV DNA>2.0 ×103 IU/ml) or active infections which require systematic antibiotics therapy or concurred with unexplainable fever before drug treatment.
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- History of pulmonary fibrosis or interstitial pneumonia including pneumoconiosis and radiation pulmonary fibrosis beyond radiation field.
- Participants with dysphagia.
- Participants with incontrollable hydrops in third lumen such as malignant pleural effusion and ascites.
- Participants with Diarrhea > Grade 2 (according to CTCAE 4.03)
- Any clinically significant gastrointestinal abnormalities, which may impair absorption of ZSP1602, such as Crohn's disease, ulcerative colitis and subtotal gastrectomy.
- Participants with major surgery or active peptic ulcer disease or unrecovered wound.
- History of myocardial infarction or congestive heart-failure (CHF) at NYHA≥3 level within 6 months prior to enrollment.
- Has either a history of uncontrollable or unstable angina pectoris or a history of severe or uncontrollable ventricular arrhythmia.
- Participants with QTcF prolongations in electrocardiogram (ECG) baseline (QTcF>450ms for males or QTcF>470ms for females) or with high risk factors leading to QT intervals prolonging (including hypokalemia, familial QT interval prolongation syndrome).
- Participants with concomitant illness such as hemorrhagic or thrombotic diseases or with anticoagulant treatment in routine dose for the moment.
- Participants with medications known to be moderate and strong inhibitors or inducers of CYP3A4 during screening and that cannot be discontinued before starting treatment with ZSP1602.
- History of most recently chemotherapy, radiotherapy, or non-antibody antitumor biologics within 4 weeks prior to the first ZSP1602 treatment and last time medication of nitrosoureas, mitomycin C or doxorubicin within 6 weeks and latest usage of antibody antitumor biologics within 8 weeks.
- History of autoimmune disease.
- History of allergic reactions to ZSP1602, any of the excipients of ZSP1602 or similar compounds.
- Pregnant or nursing women.
- Participants who, in the judgment of the investigator, will be unfit for the study. ( For reasons such as poor compliance, unsuitable for venous catheterization and so on)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130000
Chengying, MD, jl.cheng@163.com
About this study
Official title: A Phase 1, Open-Label, Dose-Escalation and Expansion, Safety and Tolerability Study of ZSP1602 in Participants With Advanced Solid Tumors
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics, and determine the maximum tolerated dose of ZSP1602 in participants with basal cell carcinoma, adenocarcinoma of esophagogastric junction, small cell lung cancer, neuroendocrine neoplasm and other advanced solid tumors.
- Conditions
- Basal Cell Carcinoma, Medulloblastoma, Adenocarcinoma of Esophagogastric Junction, Small Cell Lung Cancer, Neuroendocrine Neoplasm, Glioblastoma
- Being tested
- ZSP1602
- Medical subject headings
- Carcinoma, Basal Cell, Medulloblastoma, Small Cell Lung Carcinoma, Neuroendocrine Tumors, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZSP1602Drug
ZSP1602 capsules for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Participants with advanced solid tumors including basal cell carcinoma and medulloblastoma, regardless of SMO or Gli1 alteration status. Receives: Drug: ZSP1602 |
| Part 2 Cohort A | Experimental | Participants with Adenocarcinoma of Esophagogastric Junction with SMO or Gli1 protein overexpression alteration. Receives: Drug: ZSP1602 |
| Part 2 Cohort B | Experimental | Participants with basal cell carcinoma, small cell lung cancer, neuroendocrine neoplasm and glioblastoma with SMO or Gli1 protein overexpression alteration. Receives: Drug: ZSP1602 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting Toxicity (DLT)
To determine the DLT of ZSP1602 in advanced solid tumor participants accessed by CTCAE4.03
Measured: At day 32 after first dosing.
Maximum tolerated dose (MTD)
The highest dose at the level with <= 2/6 participants experienced DLT.
Measured: At day 32 after first dosing.
Secondary outcomes (8)
Time to progression (TTP)
For Part1 and Part2
Measured: From Screening, Day 28 of Cycle1 (28 days), then every 8 weeks, until disease progression or discontinuation from study (approximately 18 months or earlier if participants terminate from the study).
Over all response (ORR)
For Part1 and Part2
Measured: From Screening, Day 28 of Cycle1 (28 days), then every 8 weeks, until disease progression or discontinuation from study (approximately 18 months or earlier if participants terminate from the study).
Cmax of ZSP1602
For Part1 and Part2
Measured: Protocol-defined time points during Cycles 0 (4 days) and 1 (28 days) of treatment per participants.
Tmax of ZSP1602
For Part1 and Part2
Measured: Protocol-defined time points during Cycles 0 (4 days) and 1 (28 days) of treatment per participants.
Cmin of ZSP1602
For Part1 and Part2
Measured: Protocol-defined time points during Cycles 0 (4 days) and 1 (28 days) of treatment per participants.
AUC0-t of ZSP1602
For Part1 and Part2
Measured: Protocol-defined time points during Cycles 0 (4 days) and 1 (28 days) of treatment per participants.
T1/2 of ZSP1602
For Part1 and Part2
Measured: Protocol-defined time points during Cycles 0 (4 days) and 1 (28 days) of treatment per participants.
Cl/F of ZSP1602
For Part1 and Part2
Measured: Protocol-defined time points during Cycles 0 (4 days) and 1 (28 days) of treatment per participants.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start25 Jan 2019
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Zhongsheng Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734913
- Sponsor's protocol ID
- ZSP1602-16-01
- Status last verified
- Jul 2020
- First submitted
- 5 Nov 2018
- Last updated
- 22 Jul 2020
- 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 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Dose-Escalation and Expansion, Safety and Tolerability Study of ZSP1602 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03734913
- Acronym / sponsor ID
- ZSP1602-16-01
- Conditions
- Basal Cell Carcinoma, Medulloblastoma, Adenocarcinoma of Esophagogastric Junction, Small Cell Lung Cancer, Neuroendocrine Neoplasm, Glioblastoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Guangdong Zhongsheng Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 8 Nov 2018 (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 and pharmacokinetics, and determine the maximum tolerated dose of ZSP1602 in participants with basal cell carcinoma, adenocarcinoma of esophagogastric junction, small cell lung cancer, neuroendocrine neoplasm and other advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: ZSP1602Participants with advanced solid tumors including basal cell carcinoma and medulloblastoma, regardless of SMO or Gli1 alteration status. |
| Part 2 Cohort A | Experimental | Drug: ZSP1602Participants with Adenocarcinoma of Esophagogastric Junction with SMO or Gli1 protein overexpression alteration. |
| Part 2 Cohort B | Experimental | Drug: ZSP1602Participants with basal cell carcinoma, small cell lung cancer, neuroendocrine neoplasm and glioblastoma with SMO or Gli1 protein overexpression alteration. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Participants are required to meet all the criteria below in order to be included in the trial:
- Confirmed diagnosis of advanced solid tumors by histological or cytological examination, Participants have no effective standard anticancer therapy available or is intolerant to standard anticancer therapy. For Part 1 Dose Ascending Stage, and Part 2 Dose expansion Stage:
- For Part 1: Advanced solid tumors including basal cell carcinoma and medulloblastoma, regardless of SMO or Gli1 alteration status.
- For Part 2: Participants will be enrolled into cohort A and cohort B. Cohort A: Participants with Adenocarcinoma of Esophagogastric Junction with SMO or Gli1 protein overexpression alteration. (IHC≥1%) Cohort B: Participants with basal cell carcinoma, small cell lung cancer, neuroendocrine neoplasm and glioblastoma with SMO or Gli1 protein overexpression alteration. (IHC≥1%)
- Bone marrow function: absolute neutrophil count (ANC)≥1.5×10^9/L; hemoglobin (HB)≥90 g/L; Platelet count (PLT)≥75×10^9/L.
Key exclusion criteria (22 listed)
- Eligible participants must not meet any of the following exclusion criteria:
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 |
|---|---|---|
| ZSP1602ZSP1602 capsules for oral administration | Drug | Part 1, Part 2 Cohort A, Part 2 Cohort B |
Primary outcome
Dose-limiting Toxicity (DLT)
Time frame: At day 32 after first dosing.
To determine the DLT of ZSP1602 in advanced solid tumor participants accessed by CTCAE4.03
Maximum tolerated dose (MTD)
Time frame: At day 32 after first dosing.
The highest dose at the level with <= 2/6 participants experienced DLT.
8 secondary outcomes
Time to progression (TTP)
Time frame: From Screening, Day 28 of Cycle1 (28 days), then every 8 weeks, until disease progression or discontinuation from study (approximately 18 months or earlier if participants terminate from the study).
Over all response (ORR)
Time frame: From Screening, Day 28 of Cycle1 (28 days), then every 8 weeks, until disease progression or discontinuation from study (approximately 18 months or earlier if participants terminate from the study).
Cmax of ZSP1602
Time frame: Protocol-defined time points during Cycles 0 (4 days) and 1 (28 days) of treatment per participants.
Tmax of ZSP1602
Time frame: Protocol-defined time points during Cycles 0 (4 days) and 1 (28 days) of treatment per participants.
Cmin of ZSP1602
Time frame: Protocol-defined time points during Cycles 0 (4 days) and 1 (28 days) of treatment per participants.
AUC0-t of ZSP1602
Time frame: Protocol-defined time points during Cycles 0 (4 days) and 1 (28 days) of treatment per participants.
T1/2 of ZSP1602
Time frame: Protocol-defined time points during Cycles 0 (4 days) and 1 (28 days) of treatment per participants.
Cl/F of ZSP1602
Time frame: Protocol-defined time points during Cycles 0 (4 days) and 1 (28 days) of treatment per participants.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- 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.
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 ZSP1602 in people with Basal Cell Carcinoma and Medulloblastoma, run by Guangdong Zhongsheng Pharmaceutical 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 17 inclusion and 22 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 22 Jul 2020. 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 Ying Cheng, MD (+8643185871902, jl.cheng@163.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 day 32 after first dosing.). The study lists 2 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 22 Jul 2020.