A First in Human, Dose Escalation Study of JAB-3068 （SHP2 Inhibitor） in Adult Patients With Advanced Solid Tumors

NCT ID: NCT03518554

Last Updated: 2024-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-23
• Study Completion Date: 2022-02-03

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JAB-3068 (SHP2 inhibitor)

Daily oral administration of JAB-3068

Group Type: EXPERIMENTAL

JAB-3068

Intervention Type: DRUG

JAB-3068 will be orally administered on a daily basis. Patients need to fast 2 hours before （6 hours for PK days) and 2 hours after each dosing.

Interventions

JAB-3068

JAB-3068 will be orally administered on a daily basis. Patients need to fast 2 hours before （6 hours for PK days) and 2 hours after each dosing.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jacobio Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacobio Pharmaceuticals

Role: STUDY_DIRECTOR

Jacobio Pharmaceuticals Co., Ltd.

Locations

HealthONE Clinic Services Oncology-Hematology

Denver, Colorado, United States

Florida Cancer Specialists

Sarasota, Florida, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

JAB-3068-01

Identifier Type: -

Identifier Source: org_study_id