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

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ClinicalTrials.gov Identifier: NCT03518554
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : March 12, 2019
Sponsor:
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 : November 2019
Estimated Study Completion Date : April 2020

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

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

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 ClinicalTrials.gov identifier (NCT number): NCT03518554


Contacts
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Contact: Jacobio Pharmaceuticals 86 10 56315466 clinicaltrials@jacobiopharma.com

Locations
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United States, Colorado
HealthONE Clinic Services Oncology-Hematology Recruiting
Denver, Colorado, United States, 80202
Contact: Kelly Mozzetta    720-754-4646    Kelly.Mozzetta@sarahcannon.com   
Principal Investigator: Gerald S Falchook, MD         
United States, Florida
Florida Cancer Specialists Recruiting
Sarasota, Florida, United States, 37203
Contact: Katie Hanchey    941-377-9993    KHanchey@flcancer.com   
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    Kayla.Karan@SarahCannon.com   
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.
Investigators
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Study Director: Jacobio Pharmaceuticals Jacobio Pharmaceuticals Co., Ltd.

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Responsible Party: Jacobio Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT03518554     History of Changes
Other Study ID Numbers: JAB-3068-01
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Esophageal Neoplasms
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Esophageal Diseases
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Lung Diseases
Respiratory Tract Diseases
Digestive System Diseases
Gastrointestinal Diseases