A Phase 1 Study of KBP-5209 in Patients With Advanced Solid Tumors
Sponsored by Sihuan Pharmaceutical Holdings Group Ltd.
About this trial
Last updated 3 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 6 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- Age 18 years or older;
- Patients with histologically or cytologically confirmed, advanced solid tumors which have progressed despite standard therapy or for whom no standard therapy exists.
- Patients must have at least one measurable or non-measurable lesion (dose escalation only) as defined by RECIST v1.1
- Eastern Cooperative Oncology Group performance score 0 to 2;
Exclusion Criteria
- Patients with symptomatic CNS metastases;
- Patients who have a known history of hepatitis C or chronic active hepatitis B or a known diagnosis of HIV
- Any significant ophthalmologic abnormality
- Patients who have any severe and/or uncontrolled medical conditions
- Significant gastrointestinal abnormalities,
- Patients who have impaired cardiac function or clinically significant cardiac diseases,
- Chemotherapy, biologic therapy, immunotherapy, radiotherapy or investigational agents within 5 half-lives or within 4 weeks (whichever is longer) prior to administration of the first dose of study drug on Day 1 or have not recovered from the side effects of such therapy;
- Treatment with third generation EGFR inhibitors
- Major surgery/surgical therapy for any cause within 4 weeks of Screening;