Cholangiocarcinoma, Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Hepatocellular Carcinoma
Conditions
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.
Interventions
DRUGZSP1241
ZSP1241 tablets for oral administration.
Sponsors
Guangdong Zhongsheng Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | At Day 7 for SAD Part and At day 28 after for MAD part | Participant with TEAEs assessed by CTCAE V5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR). | 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 | Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject. | Defined as maximum observed plasma concentration |
| Tmax of ZSP1241 | Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject. | Defined as time to maximum plasma concentration |
| Time to progression (TTP). | 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). | — |
| AUC0-t of ZSP1241 | Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject. | Defined as area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration |
| t½ of ZSP1241 | Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject. | Defined as the apparent plasma terminal phase disposition half-life |
| Cl/F of ZSP1241 | Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject. | Defined as oral dose clearance |
| Cmin of ZSP1241 | Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject. | Defined as minimum observed plasma concentration during the dosing interval |
Countries
China
Contacts
Primary ContactRuihua Xu, MD
Outcome results
None listed