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

Jacobio Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Esophageal Cancer; Other Metastatic Solid Tumors; Non-small Cell Lung Cancer; Head and Neck Cancer

Treatments: Drug: JAB-3068

Study type: Interventional

Funder types: Industry

Identifiers

NCT03518554

JAB-3068-01

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

JAB-3068 (SHP2 inhibitor)

Experimental group

Description:

Daily oral administration of JAB-3068

Treatment:

Drug: JAB-3068