Phase I/IIa Study evaluating the safety, tolerability, pharmacokinetics, and efficacy of DN022150 in patients with advanced solid tumors Harboring KRASG12D mutation
- Conditions
- Locally advanced or metastatic solid tumors
- Registration Number
- ChiCTR2400088951
- Lead Sponsor
- Zhongshan Hospital ,Fudan University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1.Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.<br>2.Male or female ,= 18 years and =75 years .<br>3.Histologically confirmed diagnosis of advanced solid tumor harbouring with KRAS G12D mutation.<br>4.ECOG performance status of 0-1.<br>5.With a life expectancy of =3 months.<br>6.Have at least one measurable lesion according to RECIST v1.1 criteria<br>7.Adequate laboratory parameters during the screening period<br>8.Agree to use reliable contraceptive methods as required by the study protocol.
1.Central nervous system (CNS) metastases<br>2.Previously received KRAS G12D inhibitors<br>3.Known history of hypersensitivity to any components of DN022150<br>4.uncontrolled fluid accumulation (e.g., pleural, pericardial, abdominal, etc.);<br>5.immunodeficiency virus (HIV) disease or a positive HIV test; or active hepatitis;<br>6. serious medical conditions at the time of screening, such as uncontrolled diabetes, chronic kidney disease requiring dialysis, etc<br>7.Prior antitumor therapy with in 4 weeks or 5 half-lives of the treatment drug, whichever was shorter<br>8.Any unresolved AEs > Common Terminology Criteria for Adverse Events (CTCAE) Grade 1<br>9.Other factors that may affect the study results as judged by investigators.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse event,AE;Dose limited toxicity ;Objective Response Rate,ORR;
- Secondary Outcome Measures
Name Time Method Disease Control Rate,DCR ;Progression Free Survival,PFS;Duration of Response,DOR;Pharamcokinetics,PK;overall survival ,OS ;