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A First-in-Human Study of JAB-8263 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.
 
ClinicalTrials.gov Identifier: NCT04587479
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : March 14, 2022
Sponsor:
Information provided by (Responsible Party):
Jacobio Pharmaceuticals Co., Ltd.

Tracking Information
First Submitted Date  ICMJE October 9, 2020
First Posted Date  ICMJE October 14, 2020
Last Update Posted Date March 14, 2022
Actual Study Start Date  ICMJE November 23, 2020
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2020)
  • Number of participants with dose limiting toxicities [ Time Frame: Approximately 2.5 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-8263
  • Find Recommended Phase 2 Dose (RP2D) of JAB-8263 [ Time Frame: Approximately 2.5 years ]
    Measurements of MTD (i.e. the highest dose of JAB-8263 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 Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2020)
  • Number of participants with adverse events [ Time Frame: Approximately 2.5 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 2.5 years ]
    Area under the plasma concentration time curve of JAB-8263
  • Cmax [ Time Frame: Approximately 2.5 years ]
    Highest observed plasma concentration of JAB-8263
  • Tmax [ Time Frame: Approximately 2.5 years ]
    Time of highest observed plasma concentration of JAB-8263
  • T1/2 [ Time Frame: Approximately 2.5 years ]
    Half life of JAB-8263
  • Objective response rate ( ORR ) [ Time Frame: Approximately 2.5 years ]
    ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
  • Duration of response ( DOR ) [ Time Frame: Approximately 2.5 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 Same as current
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 Study of JAB-8263 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-8263 in Adult Subjects With Advanced Solid Tumors
Brief Summary This is a Phase 1, first-in-human, open-label study of JAB-8263 to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and assess the DLT. 30 subjects with advanced solid tumor will be enrolled.
Detailed Description

JAB-8263 is a small-molecule inhibitor of the highly conserved bromodomain pockets of the bromodomain and extraterminal (BET) proteins.

The objectives of this study are:

To determine the maximum-tolerated dose (MTD) and assess the dose-limiting toxicity (DLT) of JAB-8263 as a single agent to adult subjects with advanced solid tumors To assess the safety and tolerability of JAB-8263 To characterize the pharmacokinetic (PK) parameters and pharmacodynamics (PDc) To evaluate preliminary antitumor activity of JAB-8263

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumors, Adult
Intervention  ICMJE Drug: JAB-8263
Variable dose, orally Q2D with 28 days each cycle
Study Arms  ICMJE Experimental: JAB-8263
Monotherapy, dose escalation
Intervention: Drug: JAB-8263
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: October 9, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects must meet all the following criteria in order to be included in the research study:

  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(ies), or are intolerant to standard therapy(ies), or have a tumor for which no standard therapy(ies) 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. History (≤3 years) of cancer that is histologically distinct from the cancer under study.
  2. Known serious allergy to investigational drug or excipients
  3. Active brain or spinal metastases
  4. History of pericarditis or Grade ≥2 pericardial effusion
  5. History of interstitial lung disease.
  6. History of Grade ≥2 active infections within 2 weeks
  7. Known human immunodeficiency virus (HIV) infection
  8. Seropositive for hepatitis B virus (HBV)
  9. Seropositive for hepatitis C virus (HCV), or HCV-RNA viral levels are not detectable.
  10. Any severe and/or uncontrolled medical conditions
  11. History of myocardial infarction, unstable angina pectoris, coronary artery bypass graft, or cerebrovascular accident
  12. Impaired cardiac function or clinically significant cardiac diseases
  13. QTcF >470 msec at screening
  14. History of medically significant thromboembolic events or bleeding diathesis
  15. Unresolved Grade >1 toxicity
  16. History of malignant biliary obstruction
  17. Pregnant or breast-feeding
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 NCT04587479
Other Study ID Numbers  ICMJE JAB-8263-1001
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
Current Responsible Party Jacobio Pharmaceuticals Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Jacobio Pharmaceuticals Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jacobio Pharmaceuticals Jacobio Pharmaceuticals
PRS Account Jacobio Pharmaceuticals Co., Ltd.
Verification Date March 2022

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