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A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT04045496
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Jacobio Pharmaceuticals Co., Ltd.

Tracking Information
First Submitted Date  ICMJE August 2, 2019
First Posted Date  ICMJE August 5, 2019
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE September 26, 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
  • Number of participants with dose limiting toxicities [ Time Frame: Approximately 2 years ]
    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-3312.
  • Find Recommended Phase 2 Dose (RP2D) of JAB-3312 [ Time Frame: Approximately 2 years ]
    Measurements of MTD (i.e. the highest dose of JAB-3068 associated with the occurrence of Dose Limiting Toxicities (DLTs) in <33% of patients) or the RP2D (i.e. the highest tested dose that is declared safe and tolerable by the Investigators and Sponsor)
Original Primary Outcome Measures  ICMJE
 (submitted: August 2, 2019)
  • Number of participants with dose limiting toxicities [ Time Frame: up to 21-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-3312.
  • Find Recommended Phase 2 Dose (RP2D) of JAB-3312 [ Time Frame: Approximately 2 years ]
    Measurements of MTD (i.e. the highest dose of JAB-3068 associated with the occurrence of Dose Limiting Toxicities (DLTs) in <33% of patients) or the RP2D (i.e. the highest tested dose that is declared safe and tolerable by the Investigators and Sponsor)
Change History Complete list of historical versions of study NCT04045496 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
  • 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
  • Area under the curve [ Time Frame: Approximately 2 years ]
    Area under the plasma concentration time curve of JAB-3312
  • Cmax [ Time Frame: Approximately 2 years ]
    Highest observed plasma concentration of JAB-3312
  • Tmax [ Time Frame: Approximately 2 years ]
    Time of highest observed plasma concentration of JAB-3312
  • T1/2 [ Time Frame: Approximately 2 years ]
    Half life of JAB-3312
  • Objective response rate ( ORR ) [ Time Frame: Approximately 2 years ]
    ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
  • Duration of response ( DOR ) [ 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2019)
  • 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
  • Area under the curve [ Time Frame: Approximately 2 years ]
    Area under the plasma concentration time curve of JAB-3312
  • Cmax [ Time Frame: Approximately 2 years ]
    Highest observed plasma concentration of JAB-3312
  • Tmax [ Time Frame: Approximately 2 years ]
    Time of highest observed plasma concentration of JAB-3312
  • T1/2 [ Time Frame: Approximately 2 years ]
    Half life of JAB-3312
  • Objective response rate [ Time Frame: Approximately 2 years ]
    ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors
Official Title  ICMJE A Phase 1, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 in Adult Patients With Advanced Solid Tumors
Brief Summary This is a Phase 1, first-in-human, open-label dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and assess the DLT of JAB-3312. It is anticipated that approximately 24 subjects will be enrolled in the dose-escalation phase of the study. JAB-3312 will be administered orally once daily (QD) in 21-day treatment cycles.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-small Cell Lung Cancer
  • Colorectal Cancer
  • Pancreatic Ductal Carcinoma
  • Esophageal Squamous Cell Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Breast Cancer
  • Other Solid Tumors
Intervention  ICMJE Drug: JAB-3312
JAB-3312 will be supplied as 0.25 mg and 1.0 mg capsules.
Study Arms  ICMJE Experimental: JAB-3312
JAB-3312 will be administered orally once daily in 21 days treatment cycles.
Intervention: Drug: JAB-3312
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 2, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF).
  2. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  3. Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists.
  4. Subjects with life expectancy ≥3 months.
  5. Patients must have at least one measurable lesion as defined by RECIST v1.1.
  6. Patients who have sufficient baseline organ function.

Exclusion Criteria:

  1. Severe autoimmune disease (including immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone >10 mg/day or equivalent).
  2. Known malignant central nervous system disease other than neurologically stable, treated brain metastases.
  3. History or evidence of interstitial lung disease, radiation pneumonitis which required steroid treatment, or idiopathic pulmonary fibrosis, pleural or pericardial effusion that required intervention such as a drain.
  4. 8. History of seropositive status for hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
  5. History or evidence of active infections (Grade ≥2).
  6. History or evidence of significant inflammatory or vascular eye disorder.
  7. History of an allogeneic bone marrow or solid organ transplant.
  8. Use of systemic anti-cancer agent (except for anti-androgen therapy for prostate cancer) or investigational drug ≤28 days prior to the first dose of JAB-3312.
  9. History of radiation therapy ≤28 days prior to the first dose of JAB-3312, or likely to require radiation therapy at any time until the 30 days after the last dose of JAB-3312.
  10. History of transfusion of whole blood, red blood cell or platelet packets ≤2 weeks before the start of treatment.
  11. Subjects experiencing unresolved Grade >1 toxicity before the start of treatment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jacobio Pharmaceuticals 86 10 56315466 clinicaltrials@jacobiopharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04045496
Other Study ID Numbers  ICMJE JAB-3312-1001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jacobio Pharmaceuticals Co., Ltd.
Study Sponsor  ICMJE Jacobio Pharmaceuticals Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jacobio Pharmaceuticals Jacobio Pharmaceuticals
PRS Account Jacobio Pharmaceuticals Co., Ltd.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP