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

Phase 1

Completed

• Conditions: Non-small Cell Lung Cancer; Head and Neck Cancer; Esophageal Cancer; Other Metastatic Solid Tumors
• Interventions: Drug: JAB-3068

• Registration Number: NCT03518554
• Lead Sponsor: Jacobio Pharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-06
• Study Start: 2018-04-23
• Study First Submitted QC: 2018-05-04
• Study First Posted: 2018-05-08
• Primary Completion: 2022-02-03
• Study Completion: 2022-02-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
JAB-3068 (SHP2 inhibitor)	JAB-3068	Daily oral administration of JAB-3068

Primary Outcome Measures

Name	Time	Method
Number of participants with dose limiting toxicities	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 Outcome Measures

Name	Time	Method
Area under the curve	Approximately 2 years	Area under the plasma concentration time curve of JAB-3068
Cmax	Approximately 2 years	Highest observed plasma concentration of JAB-3068
Tmax	Approximately 2 years	Time of highest observed plasma concentration of JAB-3068
T1/2	Approximately 2 years	Half life of JAB-3068
Objective response rate	Approximately 2 years	ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Number of participants with adverse events	Approximately 2 years	All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments
Duration of response	Approximately 2 years	DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.

Trial Locations

Locations (4)

HealthONE Clinic Services Oncology-Hematology; 🇺🇸 Denver, Colorado, United States

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

Florida Cancer Specialists; 🇺🇸 Sarasota, Florida, United States

The University of Texas M. D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States