Brief Title
A Phase 1 Study of ZSP1241 in Participants With Advanced Solid Tumors
Official Title
A Phase 1, Open-Label, Dose-Escalation and Expansion, Safety and Tolerability Study of ZSP1241 in Participants With Advanced Solid Tumors
Brief 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.
Study Phase
Phase 1
Study Type
Interventional
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)
Secondary Outcome
Time to progression (TTP).
Condition
Hepatocellular Carcinoma
Intervention
ZSP1241
Study Arms / Comparison Groups
Part 1
Description: Participants with advanced solid tumors including hepatocellular carcinoma, cholangiocarcinoma, gastric cancer, esophageal cancer, colorectal cancer and other advanced solid tumors.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
90
Start Date
November 13, 2018
Completion Date
October 31, 2021
Primary Completion Date
October 31, 2021
Eligibility Criteria
Inclusion Criteria:
- Participants are required to meet all the criteria below in order to be included in
the trial:
1. Male or female patient, aged 18 ~ 75 years.
2. 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.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Participants with at least 1 measurable tumor lesion based on RECIST 1.1.
5. 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.
6. Life expectancy ≥ 12 weeks.
7. 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).
8. Child-Pugh class A (only for hepatocellular carcinoma and cholangiocarcinoma).
9. 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.
10. Participants with voluntarily signature Informed Consent Form (ICF) prior to
screening.
Exclusion Criteria:
- Eligible participants must not meet any of the following exclusion criteria:
1. Participants who have intracranial tumor and/or brain metastases with clinical
symptoms needed treatment are ineligible not including the following :
1. recovery from the therapy (including radiotherapy and/or surgery) 4 weeks
before enrollment.
2. 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.
2. 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.
3. Participants with dysphagia.
4. Participants with incontrollable hydrops in third lumen such as malignant pleural
effusion and ascites.
5. Participants with history of pulmonary fibrosis or interstitial pneumonia
including pneumoconiosis and radiation pulmonary fibrosis beyond radiation field.
6. Participants who suffer from irritable bowel syndrome and need medication.
7. Participants with any clinically significant gastrointestinal abnormalities such
as Crohn's disease, ulcerative colitis and subtotal gastrectomy.
8. Participants with major surgery in recent 4 weeks or active peptic ulcer disease
or unrecovered wound.
9. Participants with history of myocardial infarction or congestive heart-failure
(CHF) at NYHA≥3 level within 6 months prior to enrollment.
10. Participants with LVEF<50% during screening.
11. 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.
12. 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.
13. 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.
14. 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.
15. Participants with history of autoimmune disease.
16. Pregnant or nursing women.
17. 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)
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
, +862087343333, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT03734926
Organization ID
ZSP1241-18-01
Responsible Party
Sponsor
Study Sponsor
Guangdong Zhongsheng Pharmaceutical Co., Ltd.
Study Sponsor
, ,
Verification Date
July 2020