Hepatocellular CarcinomaPhase 1NCT03734926
A Phase 1 Study of ZSP1241 in Participants With Advanced Solid Tumors
A Phase 1 study testing ZSP1241 in people with Hepatocellular Carcinoma and Cholangiocarcinoma, 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 ZSP1241 in participants with hepatocellular carcinoma, cholangiocarcinoma, gastric cancer, esophageal cancer, colorectal cancer and other advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma, Cholangiocarcinoma, Gastric Cancer
- What is being tested?
- ZSP1241
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2018to 31 Oct 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 patient, 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Participants with at least 1 measurable tumor lesion based on RECIST 1.1.
- Recovery from past medical history of adverse reactions (excluding alopecia and neurotoxicity) caused by radiotherapy and/or chemotherapy to NCI CTCAE 5.0 Grade ≤ 1 or baseline level.
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- Life expectancy ≥ 12 weeks.
- Adequate organ function, defined by the following laboratory results, to be obtained prior to enrollment:
- Bone marrow function: ANC≥1.5×109/L; HB≥90 g/L; PLT≥75×109/L. Liver function: ALT≤2.5×ULN, AST≤2.5×ULN, ALP≤2.5×ULN, TBIL≤1.5×ULN; ALT≤5×ULN, AST≤5×ULN (For participants with liver focal masses and metastasis).
- Renal function: creatinine≤1.5×ULN; CL≥ 50 mL/min. Coagulation function: INR≤1.5×ULN; INR≤2.3×ULN (For participants with liver focal masses and metastasis).
- Child-Pugh class A (only for hepatocellular carcinoma and cholangiocarcinoma).
- Participants (including partners) who have no gestation plans and are willing to follow reliable contraceptive measures during the study and until 8 months after the last dosing.
- Participants with voluntarily signature Informed Consent Form (ICF) prior to screening.
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 needed treatment are ineligible not including the following :
- 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, no need to medication by hormone or anticonvulsants, and predicted to be clinically stable during the study.
- Participants who suffer from chronic and active infective diseases and require systemic antibiotic, antifungal, or antiviral treatment except concomitant antiviral systemic therapy for chronic hepatitis B or C.
- Participants with dysphagia.
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- Participants with incontrollable hydrops in third lumen such as malignant pleural effusion and ascites.
- Participants with history of pulmonary fibrosis or interstitial pneumonia including pneumoconiosis and radiation pulmonary fibrosis beyond radiation field.
- Participants who suffer from irritable bowel syndrome and need medication.
- Participants with any clinically significant gastrointestinal abnormalities such as Crohn's disease, ulcerative colitis and subtotal gastrectomy.
- Participants with major surgery in recent 4 weeks or active peptic ulcer disease or unrecovered wound.
- Participants with history of myocardial infarction or congestive heart-failure (CHF) at NYHA≥3 level within 6 months prior to enrollment.
- Participants with LVEF<50% during screening.
- Participants with QTcF prolongations in ECG baseline ( QTcF>450ms for males or QTcF>470ms for females) or high risk factors leading to QT intervals prolonging (including hypokalemia, familial QT interval prolongation syndrome) or a history of uncontrollable blood pressure or a history of severe or uncontrollable ventricular arrhythmia such as two or three degree atrioventricular block.
- Participants with medications known as QTc prolongation or TDP ventricular tachycardia inducer or strong inhibitors and inducers of CYP3A4 not less than 5 days or 5 half-times before first dosing ZSP1241.
- Participants with history of most recently chemotherapy, radiotherapy, or non-antibody antitumor biologics within 4 weeks prior to the first ZSP1241 treatment and last time medication of nitrosoureas, mitomycin C or doxorubicin within 6 weeks and latest usage of antibody antitumor biologics within 4 weeks.
- Participants with current or prior retinal detachment or presently confirmed diagnosis keratopathy including but not limited to bullous keratopathy, calcific band keratopathy, corneal abrasion, keratohelcosis, keratitis and so on.
- Participants with history of autoimmune disease.
- 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
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ruihua XU, MD, +862087343333, xurh@sysucc.org.cn
About this study
Official title: A Phase 1, Open-Label, Dose-Escalation and Expansion, Safety and Tolerability Study of ZSP1241 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 ZSP1241 in participants with hepatocellular carcinoma, cholangiocarcinoma, gastric cancer, esophageal cancer, colorectal cancer and other advanced solid tumors.
- Conditions
- Hepatocellular Carcinoma, Cholangiocarcinoma, Gastric Cancer, Esophageal Cancer, Colorectal Cancer
- Being tested
- ZSP1241
- Medical subject headings
- Carcinoma, Hepatocellular, Cholangiocarcinoma, Stomach Neoplasms, Esophageal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZSP1241Drug
ZSP1241 tablets for oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Participants with advanced solid tumors including hepatocellular carcinoma, cholangiocarcinoma, gastric cancer, esophageal cancer, colorectal cancer and other advanced solid tumors. Receives: Drug: ZSP1241 |
| Part 2 Cohort A | Experimental | Participants with hepatocellular carcinoma. Receives: Drug: ZSP1241 |
| Part 2 Cohort B | Experimental | Participants with gastric cancer, esophageal cancer, colorectal cancer and other advanced solid tumor. Receives: Drug: ZSP1241 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of ZSP1241 in single dose ascending (SAD) and multiple dose ascending (MAD) as measured by assessment of maximum tolerated dose (MTD), dose limiting toxicity (DLT) and treatment emergent adverse events (TEAEs)
Participant with TEAEs assessed by CTCAE V5.0
Measured: At Day 7 for SAD Part and At day 28 after for MAD part
Secondary outcomes (8)
Time to progression (TTP).
Measured: Screening, Day 28 of Cycle 1 (28 days), then every 6 weeks for hepatocellular carcinoma or 8 weeks for other advanced solid tumors, until disease progression or discontinuation from study (up to 18 months).
Overall response rate (ORR).
Measured: Screening, Day 28 of Cycle 1 (28 days), then every 6 weeks for hepatocellular carcinoma or 8 weeks for other advanced solid tumors, until disease progression or discontinuation from study (up to 18 months).
Cmax of ZSP1241
Defined as maximum observed plasma concentration
Measured: Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.
Tmax of ZSP1241
Defined as time to maximum plasma concentration
Measured: Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.
Cmin of ZSP1241
Defined as minimum observed plasma concentration during the dosing interval
Measured: Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.
AUC0-t of ZSP1241
Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration
Measured: Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.
t½ of ZSP1241
Defined as the apparent plasma terminal phase disposition half-life
Measured: Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.
Cl/F of ZSP1241
Defined as oral dose clearance
Measured: Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.
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 start13 Nov 2018
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular 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
- 90 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
- NCT03734926
- Sponsor's protocol ID
- ZSP1241-18-01
- 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
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 ZSP1241 in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03734926
- Acronym / sponsor ID
- ZSP1241-18-01
- Conditions
- Hepatocellular Carcinoma, Cholangiocarcinoma, Gastric Cancer, Esophageal Cancer, Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Guangdong Zhongsheng Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 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 ZSP1241 in participants with hepatocellular carcinoma, cholangiocarcinoma, gastric cancer, esophageal cancer, colorectal cancer 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: ZSP1241Participants with advanced solid tumors including hepatocellular carcinoma, cholangiocarcinoma, gastric cancer, esophageal cancer, colorectal cancer and other advanced solid tumors. |
| Part 2 Cohort A | Experimental | Drug: ZSP1241Participants with hepatocellular carcinoma. |
| Part 2 Cohort B | Experimental | Drug: ZSP1241Participants with gastric cancer, esophageal cancer, colorectal cancer and other advanced solid tumor. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participants are required to meet all the criteria below in order to be included in the trial:
- Bone marrow function: ANC≥1.5×109/L; HB≥90 g/L; PLT≥75×109/L. Liver function: ALT≤2.5×ULN, AST≤2.5×ULN, ALP≤2.5×ULN, TBIL≤1.5×ULN; ALT≤5×ULN, AST≤5×ULN (For participants with liver focal masses and metastasis).
- Renal function: creatinine≤1.5×ULN; CL≥ 50 mL/min. Coagulation function: INR≤1.5×ULN; INR≤2.3×ULN (For participants with liver focal masses and metastasis).
Key exclusion criteria (20 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 |
|---|---|---|
| ZSP1241ZSP1241 tablets for oral administration. | Drug | Part 1, Part 2 Cohort A, Part 2 Cohort B |
Primary outcome
Safety and tolerability of ZSP1241 in single dose ascending (SAD) and multiple dose ascending (MAD) as measured by assessment of maximum tolerated dose (MTD), dose limiting toxicity (DLT) and treatment emergent adverse events (TEAEs)
Time frame: At Day 7 for SAD Part and At day 28 after for MAD part
Participant with TEAEs assessed by CTCAE V5.0
8 secondary outcomes
Time to progression (TTP).
Time frame: Screening, Day 28 of Cycle 1 (28 days), then every 6 weeks for hepatocellular carcinoma or 8 weeks for other advanced solid tumors, until disease progression or discontinuation from study (up to 18 months).
Overall response rate (ORR).
Time frame: Screening, Day 28 of Cycle 1 (28 days), then every 6 weeks for hepatocellular carcinoma or 8 weeks for other advanced solid tumors, until disease progression or discontinuation from study (up to 18 months).
Cmax of ZSP1241
Time frame: Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.
Tmax of ZSP1241
Time frame: Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.
Cmin of ZSP1241
Time frame: Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.
AUC0-t of ZSP1241
Time frame: Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.
t½ of ZSP1241
Time frame: Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.
Cl/F of ZSP1241
Time frame: Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.
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.
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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 ZSP1241 in people with Hepatocellular Carcinoma and Cholangiocarcinoma, 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 13 inclusion and 20 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 Ruihua Xu, MD (+862087343333, xurh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of ZSP1241 in single dose ascending (SAD) and multiple dose ascending (MAD) as measured by assessment of maximum tolerated dose (MTD), dose limiting toxicity (DLT) and treatment emergent adverse events (TEAEs) (time frame: At Day 7 for SAD Part and At day 28 after for MAD part). 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.