Locally advanced or metastatic solid tumors
Conditions
Interventions
group 1(dose escalation):DN022150 20mg fixed dose group
group 2(dose escalation):DN022150 50mg fixed dose group
group 3(dose escalation):DN022150 100mg fixed dose group
group 4(dose escalation):DN022150 200mg fixed dose group
group 5(dose escalation):DN022150 300mg fixed dose group
dose expansion:DN022150(recommend phase 2 dose)
Indication exploration:DN022150(recommend phase 2 dose)
Sponsors
Zhongshan Hospital ,Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Subjects must voluntarily agree to participate in the trial and sign a written informed consent form. 2.Male or female ,= 18 years and =75 years . 3.Histologically confirmed diagnosis of advanced solid tumor harbouring with KRAS G12D mutation. 4.ECOG performance status of 0-1. 5.With a life expectancy of =3 months. 6.Have at least one measurable lesion according to RECIST v1.1 criteria 7.Adequate laboratory parameters during the screening period 8.Agree to use reliable contraceptive methods as required by the study protocol.
Exclusion criteria
Exclusion criteria: 1.Central nervous system (CNS) metastases 2.Previously received KRAS G12D inhibitors 3.Known history of hypersensitivity to any components of DN022150 4.uncontrolled fluid accumulation (e.g., pleural, pericardial, abdominal, etc.); 5.immunodeficiency virus (HIV) disease or a positive HIV test; or active hepatitis; 6. serious medical conditions at the time of screening, such as uncontrolled diabetes, chronic kidney disease requiring dialysis, etc 7.Prior antitumor therapy with in 4 weeks or 5 half-lives of the treatment drug, whichever was shorter 8.Any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 9.Other factors that may affect the study results as judged by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event,AE;Dose limited toxicity ;Objective Response Rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate,DCR ;Progression Free Survival,PFS;Duration of Response,DOR;Pharamcokinetics,PK;overall survival ,OS ; | — |
Countries
China
Contacts
Public ContactTianshu Liu
Zhongshan Hospital ,Fudan University
Outcome results
None listed