A First-in-Human Study of JAB-3068 (SHP2 Inhibitor) in Adult Patients With Advanced Solid Tumors … (NCT03565003) | Clinical Trial Compass
CompletedPhase 1/2
A First-in-Human Study of JAB-3068 (SHP2 Inhibitor) in Adult Patients With Advanced Solid Tumors in China
China126 participantsStarted 2018-11-20
Plain-language summary
This is a Phase 1/2a, open-label, multi-center study of JAB-3068 in Patients with advanced solid tumors.This study has two phases: dose escalation phase and dose expansion phase.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Written informed consent obtained prior to any study-related procedure being performed;
✓. Age 18 years or older;
✓. Dose escalation(phase I): Patients with histologically or cytologically confirmed, advanced solid tumors (including lymphoma) which have progressed from standard therapy or for whom no standard therapy exists; Dose expansion(phase IIa ): Patients with histologically or cytologically confirmed, advanced NSCLC, ESCC, HNSCC which have progressed from standard therapy;
✓. Patients with life expectancy ≥3 months;
✓. Dose expansion(phase IIa ): patients have available archival tissue can be provided or willing to perform biopsy to provide fresh tumor tissue.
✓. Patients with other solid tumors must have at least one measurable lesion as defined by RECIST v1.1;Patients with Lymphomas must have at least one measurable lesion as defined by IWG 2007 criteria;
✓. 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;
✕. Lymphoma with brain metastasis; Other solid tumors:Known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases;
What they're measuring
1
Number of participants with dose limiting toxicities
Timeframe: At the end of Cycle 1 (each cycle is 28 days)
✕. 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
✕. Patients who have impaired cardiac function or clinically significant cardiac diseases
✕. Use of anti-cancer treatment drug ≤21 days prior to the first dose of JAB-3068.
✕. Use of an investigational drug during the past 30 days prior to the first dose of JAB-3068.