A Phase 1, Open-Label, Dose-Escalation and Expansion, Safety and Tolerability Study of ZSP1241 in Participants With Advanced Solid Tumors

Guangdong Zhongsheng Pharmaceutical Co., Ltd.1 site in 1 country90 target enrollmentNovember 13, 2018

ConditionsHepatocellular Carcinoma Cholangiocarcinoma Gastric Cancer Esophageal Cancer Colorectal Cancer

InterventionsZSP1241

DrugsZSP1241

Overview

Phase: Phase 1
Intervention: ZSP1241
Conditions: Hepatocellular Carcinoma
Sponsor: Guangdong Zhongsheng Pharmaceutical Co., Ltd.
Enrollment: 90
Locations: 1
Primary Endpoint: 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)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 13, 2018

End Date

October 31, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Guangdong Zhongsheng Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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-
•Participants with at least 1 measurable tumor lesion based on RECIST 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.
•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).

Exclusion Criteria

•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.
•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.

Arms & Interventions

Part 1

Participants with advanced solid tumors including hepatocellular carcinoma, cholangiocarcinoma, gastric cancer, esophageal cancer, colorectal cancer and other advanced solid tumors.

Intervention: ZSP1241

Part 2 Cohort A

Participants with hepatocellular carcinoma.

Intervention: ZSP1241

Part 2 Cohort B

Participants with gastric cancer, esophageal cancer, colorectal cancer and other advanced solid tumor.

Intervention: ZSP1241

Outcomes

Primary Outcomes

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

Secondary Outcomes

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).)
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.)
Tmax of ZSP1241(Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.)
Cmin of ZSP1241(Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.)
AUC0-t of ZSP1241(Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.)
t½ of ZSP1241(Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.)
Cl/F of ZSP1241(Protocol-defined time points during Cycles 0 (7 days) and 1 (28 days) of treatment per subject.)