Clinical Trials /

A First-in-Human Study of JAB-8263 in Adult Patients With Advanced Solid Tumors

NCT04587479

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT04587479

Trial Eligibility

Document

Title

  • Brief Title: A First-in-Human Study of JAB-8263 in Adult Patients With Advanced Solid Tumors
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: JAB-8263-1001
  • NCT ID: NCT04587479

Conditions

  • Solid Tumors, Adult

Interventions

DrugSynonymsArms
JAB-8263JAB-8263

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
JAB-8263ExperimentalMonotherapy, dose escalation
  • JAB-8263

Eligibility Criteria

        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
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:Approximately 2.5 years
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-8263

Secondary Outcome Measures

Measure:Number of participants with adverse events
Time Frame:Approximately 2.5 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 2.5 years
Safety Issue:
Description:Area under the plasma concentration time curve of JAB-8263
Measure:Cmax
Time Frame:Approximately 2.5 years
Safety Issue:
Description:Highest observed plasma concentration of JAB-8263
Measure:Tmax
Time Frame:Approximately 2.5 years
Safety Issue:
Description:Time of highest observed plasma concentration of JAB-8263
Measure:T1/2
Time Frame:Approximately 2.5 years
Safety Issue:
Description:Half life of JAB-8263
Measure:Objective response rate ( ORR )
Time Frame:Approximately 2.5 years
Safety Issue:
Description:ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Measure:Duration of response ( DOR )
Time Frame:Approximately 2.5 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.

Last Updated

December 1, 2020