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

NCT03518554 | Completed Phase 1 FDA Drug

• 1 other identifier: JAB-3068-01
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Number of participants with dose limiting toxicities

  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.

  up to 28-day per cycle

Secondary Outcomes (7)

• Number of participants with adverse events

  Approximately 2 years

• Area under the curve

  Approximately 2 years

• Cmax

  Approximately 2 years

• Tmax

  Approximately 2 years

• T1/2

  Approximately 2 years

Other Outcomes (1)

• pERK

  Approximately 2 years

Study Arms (1)

JAB-3068 (SHP2 inhibitor)

EXPERIMENTAL

Daily oral administration of JAB-3068

Drug: JAB-3068

Interventions

JAB-3068 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.

JAB-3068 (SHP2 inhibitor)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jacobio Pharmaceuticals Co., Ltd.: lead

Study Sites (4)

HealthONE Clinic Services Oncology-Hematology

Denver, Colorado, 80202, United States

Location

Florida Cancer Specialists

Sarasota, Florida, 37203, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms; Esophageal Neoplasms; Squamous Cell Carcinoma of Head and Neck; Noonan Syndrome; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jacobio Pharmaceuticals

  Jacobio Pharmaceuticals Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: May 8, 2018
• Study Start: April 23, 2018
• Primary Completion: February 3, 2022
• Study Completion: February 3, 2022
• Last Updated: December 16, 2024

Record last verified: 2024-12

Locations

US (4)