Advanced Solid Tumors
Conditions
Keywords
Advanced Solid Tumors, KRAS G12D
Brief summary
HS-10529 is an oral, highly selective, small molecular inhibitor of KRAS G12D. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10529 in KRAS G12D patients with advanced solid tumors.
Detailed description
This is a phase 1, first-in-human, study of HS-10529, consisting of dose escalation and dose expansion, which is aimed to assess the safety and tolerability of HS-10529 in KRAS G12D patients with advanced solid tumors and evaluate the preliminary efficacy of HS-10529.
Interventions
DRUGHS-10529
Participants in all subjucts will receive HS-10529
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least age of 18 years at screening. * Patients of advanced solid tumor，who have progressed on or intolerant to standard therapy. * With measurable lesion according to RECIST 1.1. * Agree to provide fresh or archival tumor tissue. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\ 1.
Exclusion criteria
* Previous or current treatment with KRAS G12D inhibitors. * Uncontrolled pleural, ascites or pericardial effusion. * Known and untreated, or active central nervous system metastases. * History of other primary malignant tumors. * Serious, uncontrolled, or active comorbidities. * Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The maximum tolerated dose (MTD) or maximum applicable dose (MAD) | up to 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment-emergent adverse events | up to 24 months |
| Plasma concentration of HS-10529 | up to 36 months |
Contacts
Primary ContactFangbin Liu
Outcome results
None listed