Clinical trial NCT03518554: A First in Human, Dose Escalation Study of JAB-3068 （SHP2 Inhibitor） in Adult Patients With Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer
Head and Neck Cancer
Esophageal Cancer
Other Metastatic Solid Tumors
Keywords: JAB-3068
SHP2
advanced solid tumor
NSCLC
ESCC
HNSCC
PTPN11
EGFR
Colorectal cancer
Lead sponsor: Jacobio Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-05-08
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent obtained prior to any study-related procedure being performed;
2. Age 18 years or older;
3. Patients with histologically or cytologically confirmed, advanced solid tumors which have progressed despite standard therapy or for whom no standard therapy exists;
4. Patients with life expectancy ≥3 months;
5. Patients must have at least one measurable lesion as defined by RECIST v1.1;
6. Eastern Cooperative Oncology Group performance score 0 or 1;
7. Patients who have sufficient baseline organ function.

Exclusion Criteria:

1. Patients with life-threatening autoimmune disease or with autoimmune disorder and who are on long-term steroid treatment;
2. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO;
3. Known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases;
4. Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
5. 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
6. Patients who have impaired cardiac function or clinically significant cardiac diseases;
7. Use of anti-cancer treatment drug ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of JAB-3068;
8. 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;
9. 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.

Primary outcomes:
measure: Number of participants with dose limiting toxicities
timeFrame: up to 28-day per cycle
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Approximately 2 years
measure: Area under the curve
timeFrame: Approximately 2 years
measure: Cmax
timeFrame: Approximately 2 years
measure: Tmax
timeFrame: Approximately 2 years
measure: T1/2
timeFrame: Approximately 2 years
measure: Objective response rate
timeFrame: Approximately 2 years
measure: Duration of response
timeFrame: Approximately 2 years
Other outcomes:
measure: pERK
timeFrame: Approximately 2 years
Locations:
city: Denver
country: United States
facility: HealthONE Clinic Services Oncology-Hematology
state: Colorado
city: Sarasota
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Houston
country: United States
facility: The University of Texas M. D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: Jacobio Pharmaceuticals Co., Ltd.
name: Jacobio Pharmaceuticals
role: STUDY_DIRECTOR
References: