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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03518554
• Other study ID #: JAB-3068-01
• Status: Recruiting
• Phase: Phase 1
• Start date: April 23, 2018
• Est. completion date: July 2021

Study information

• Verified date: March 2021
• Source: Jacobio Pharmaceuticals Co., Ltd.
• Contact: Jacobio Pharmaceuticals
• Phone: 86 10 56315466
• Email: clinicaltrials[@]jacobiopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Head and Neck Cancer
• Non-small Cell Lung Cancer
• Other Metastatic Solid Tumors

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	HealthONE Clinic Services Oncology-Hematology	Denver	Colorado
United States	The University of Texas M. D. Anderson Cancer Center	Houston	Texas
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Florida Cancer Specialists	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Jacobio Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pERK	On treatment versus baseline comparison of pharmacodynamic marker pERK (Phosphorylated form of Extracellular signal-regulated kinase) on newly obtained tumor biopsy samples by IHC.	Approximately 2 years
Primary	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	Number of participants with adverse events	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	Approximately 2 years
Secondary	Area under the curve	Area under the plasma concentration time curve of JAB-3068	Approximately 2 years
Secondary	Cmax	Highest observed plasma concentration of JAB-3068	Approximately 2 years
Secondary	Tmax	Time of highest observed plasma concentration of JAB-3068	Approximately 2 years
Secondary	T1/2	Half life of JAB-3068	Approximately 2 years
Secondary	Objective response rate	ORR is defined as the proportion of participants with complete response or partial response (CR+PR)	Approximately 2 years
Secondary	Duration of response	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.	Approximately 2 years