Status:
UNKNOWN
A PhaseⅠStudy of HS-10381 in Patients With Advanced Solid Tumors
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
HS-10381 is a small molecular, oral potent, SHP2 inhibitor. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacok...
Detailed Description
This is a Phase 1 open-label, multicenter study to evaluate the safety, tolerability, PK and preliminary efficacy of HS-10381 in patients with advanced solid tumors by using a "3+3" dose escalation.
Eligibility Criteria
Inclusion
- Men or women aged more than or equal to (≥) 18 years
- Advanced solid tumor patients confirmed by histology or cytology for who that standard treatment is invalid, unavailable or intolerable
- Patients have at least one target lesion according to RECEST 1.1. The requirements for target lesions are: measurable lesions without local treatment such as irradiation, or with definite progress after local treatment, with the longest diameter ≥ 10 mm in the baseline period (in case of lymph nodes, the shortest axis ≥ 15 mm is required)
- ECOG performance status was 0-1 and did not deteriorate in the previous 2 weeks
- Estimated life expectancy greater than (\>) 12 weeks
- Females should be using adequate contraceptive measures throughout the study; should not be breastfeeding at the time of screening, during the study and until 3 months after completion of the study; and must have evidence of non-childbearing potential
- Sign Informed Consent Form
Exclusion
- Treatment with any of the following:
- Previous or current treatment with drugs targeting SHP2
- Any cytotoxic chemotherapy, investigational agents or anticancer drugs within 28 days of the first dose of study drug
- Radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose.
- Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.
- Known and untreated, or active central nervous system metastases.
- Existing abnormal CTCAE≥grade 2 resulted from previous treatment
- History of other malignancy
- Inadequate bone marrow reserve or organ function
- Evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV), unless the hepatitis is considered to be cured, Known history of HIV
- History of hypersensitivity to any active or inactive ingredient of HS-10381.
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
- Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.
Key Trial Info
Start Date :
June 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT05378178
Start Date
June 8 2022
End Date
December 31 2024
Last Update
July 7 2022
Active Locations (1)
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1
West China Hospital of Sichuan University
Xi’an, Sichuan, China, 610044