Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03518554
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : March 26, 2021
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Head and Neck Cancer Esophageal Cancer Other Metastatic Solid Tumors Drug: JAB-3068 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: JAB-3068 (SHP2 inhibitor)
Daily oral administration of JAB-3068
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.

Primary Outcome Measures :
  1. Number of participants with dose limiting toxicities [ Time Frame: 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 :
  1. Number of participants with adverse events [ Time Frame: 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

  2. Area under the curve [ Time Frame: Approximately 2 years ]
    Area under the plasma concentration time curve of JAB-3068

  3. Cmax [ Time Frame: Approximately 2 years ]
    Highest observed plasma concentration of JAB-3068

  4. Tmax [ Time Frame: Approximately 2 years ]
    Time of highest observed plasma concentration of JAB-3068

  5. T1/2 [ Time Frame: Approximately 2 years ]
    Half life of JAB-3068

  6. Objective response rate [ Time Frame: Approximately 2 years ]
    ORR is defined as the proportion of participants with complete response or partial response (CR+PR)

  7. Duration of response [ Time Frame: 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.

Other Outcome Measures:
  1. pERK [ Time Frame: Approximately 2 years ]
    On treatment versus baseline comparison of pharmacodynamic marker pERK (Phosphorylated form of Extracellular signal-regulated kinase) on newly obtained tumor biopsy samples by IHC.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03518554

Layout table for location contacts
Contact: Jacobio Pharmaceuticals 86 10 56315466

Layout table for location information
United States, Colorado
HealthONE Clinic Services Oncology-Hematology Recruiting
Denver, Colorado, United States, 80202
Contact: Kelly Mozzetta    720-754-4646   
Principal Investigator: Gerald S Falchook, MD         
United States, Florida
Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 37203
Contact: Katie Hanchey    941-377-9993   
Principal Investigator: Judy Wang, M.D.         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Kayla Karan         
Contact: Kayla Karan    (615)3296815   
Principal Investigator: Todd M Bauer, MD         
United States, Texas
The University of Texas M. D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Sarina A. Piha-Paul, MD         
Principal Investigator: Sarina A. Piha-Paul, MD         
Sponsors and Collaborators
Jacobio Pharmaceuticals Co., Ltd.
Layout table for investigator information
Study Director: Jacobio Pharmaceuticals Jacobio Pharmaceuticals Co., Ltd.
Layout table for additonal information
Responsible Party: Jacobio Pharmaceuticals Co., Ltd. Identifier: NCT03518554    
Other Study ID Numbers: JAB-3068-01
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jacobio Pharmaceuticals Co., Ltd.:
advanced solid tumor
Colorectal cancer