NCT03518554
Completed
Phase 1
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 Tumors
Jacobio Pharmaceuticals Co., Ltd.4 sites in 1 country38 target enrollmentStarted: April 23, 2018Last updated:
ConditionsNon-small Cell Lung CancerHead and Neck CancerEsophageal CancerOther Metastatic Solid Tumors
InterventionsJAB-3068
DrugsJAB-3068
Overview
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 38
- Locations
- 4
- Primary Endpoint
- Number of participants with dose limiting toxicities
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Patients who have impaired cardiac function or clinically significant cardiac diseases;
- •Use of anti-cancer treatment drug ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of JAB-3068;
- •Use of an investigational drug during the past 30 days or 5 half-lives (whichever is shorter) prior to the first dose of JAB-3068;
- •No other anti-cancer therapy (chemotherapy, immunotherapy, hormonal therapy radiotherapy (except for palliative local radiotherapy), biological therapy or other novel agent is to be permitted while the patient is receiving study medication.
Arms & Interventions
JAB-3068 (SHP2 inhibitor)
Experimental
Daily oral administration of JAB-3068
Intervention: JAB-3068 (Drug)
Outcomes
Primary Outcomes
Number of participants with dose limiting toxicities
Time Frame: up to 28-day per cycle
Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle with JAB-3068.
Secondary Outcomes
- Area under the curve(Approximately 2 years)
- Cmax(Approximately 2 years)
- Tmax(Approximately 2 years)
- T1/2(Approximately 2 years)
- Objective response rate(Approximately 2 years)
- Number of participants with adverse events(Approximately 2 years)
- Duration of response(Approximately 2 years)
Investigators
Study Sites (4)
Loading locations...
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