A First in Human, Dose Escalation Study of JAB-3068 （SHP2 Inhibitor） in Adult Patients With Advan… (NCT03518554) | Clinical Trial Compass
CompletedPhase 1
A First in Human, Dose Escalation Study of JAB-3068 （SHP2 Inhibitor） in Adult Patients With Advanced Solid Tumors
United States38 participantsStarted 2018-04-23
Plain-language summary
This is a phase 1, multi-center, dose escalation, open-label study to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of JAB-3068 in adult patients with advanced solid.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent obtained prior to any study-related procedure being performed;
✓. 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 with life expectancy ≥3 months;
✓. Patients must have at least one measurable lesion as defined by RECIST v1.1;
✓. Eastern Cooperative Oncology Group performance score 0 or 1;
✓. Patients who have sufficient baseline organ function.
Exclusion criteria
✕. Patients with life-threatening autoimmune disease or with autoimmune disorder and who are on long-term steroid treatment;
✕. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO;
✕. Known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases;
✕. Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
✕. Patients who have any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the Investigator and Sponsor, could affect the patient's participation in the study
What they're measuring
1
Number of participants with dose limiting toxicities