Clinical Trials /

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

NCT03518554

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

  • ORG STUDY ID: JAB-3068-01
  • NCT ID: NCT03518554

Conditions

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

Interventions

DrugSynonymsArms
JAB-3068JAB-3068 (SHP2 inhibitor)

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
JAB-3068 (SHP2 inhibitor)ExperimentalDaily oral administration of JAB-3068
  • JAB-3068

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with dose limiting toxicities
Time Frame:up to 28-day per cycle
Safety Issue:
Description: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

Measure:Number of participants with adverse events
Time Frame:Approximately 2 years
Safety Issue:
Description: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
Measure:Area under the curve
Time Frame:Approximately 2 years
Safety Issue:
Description:Area under the plasma concentration time curve of JAB-3068
Measure:Cmax
Time Frame:Approximately 2 years
Safety Issue:
Description:Highest observed plasma concentration of JAB-3068
Measure:Tmax
Time Frame:Approximately 2 years
Safety Issue:
Description:Time of highest observed plasma concentration of JAB-3068
Measure:T1/2
Time Frame:Approximately 2 years
Safety Issue:
Description:Half life of JAB-3068
Measure:Objective response rate
Time Frame:Approximately 2 years
Safety Issue:
Description:ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Measure:Duration of response
Time Frame:Approximately 2 years
Safety Issue:
Description: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.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Jacobio Pharmaceuticals Co., Ltd.

Trial Keywords

  • JAB-3068
  • SHP2
  • advanced solid tumor
  • NSCLC
  • ESCC
  • HNSCC
  • PTPN11
  • EGFR
  • Colorectal cancer

Last Updated

March 11, 2019