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

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ClinicalTrials.gov Identifier: NCT04587479
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : December 1, 2020
Sponsor:
Information provided by (Responsible Party):
Jacobio Pharmaceuticals Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Solid Tumors, Adult Drug: JAB-8263 Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 23, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2023

Arm Intervention/treatment
Experimental: JAB-8263
Monotherapy, dose escalation
Drug: JAB-8263
Variable dose, orally Q2D with 28 days each cycle




Primary Outcome Measures :
  1. 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

  2. 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)


Secondary Outcome Measures :
  1. 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

  2. Area under the curve [ Time Frame: Approximately 2.5 years ]
    Area under the plasma concentration time curve of JAB-8263

  3. Cmax [ Time Frame: Approximately 2.5 years ]
    Highest observed plasma concentration of JAB-8263

  4. Tmax [ Time Frame: Approximately 2.5 years ]
    Time of highest observed plasma concentration of JAB-8263

  5. T1/2 [ Time Frame: Approximately 2.5 years ]
    Half life of JAB-8263

  6. 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)

  7. 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.



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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:

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

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): NCT04587479


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

Locations
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United States, Colorado
SCRI HeatlthONE Recruiting
Denver, Colorado, United States, 80218
Contact: Gerald Falchook, MD         
United States, Florida
Florida Cancer Center, Lake Mary Recruiting
Lake City, Florida, United States, 32025
Contact: Shekeab Jauhari, MD         
United States, Tennessee
Tennessee Oncology Nashville Recruiting
Nashville, Tennessee, United States, 37203
Contact: James M Pauff, MD PhD         
Sponsors and Collaborators
Jacobio Pharmaceuticals Co., Ltd.
Investigators
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Study Director: Jacobio Pharmaceuticals Jacobio Pharmaceuticals
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Responsible Party: Jacobio Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT04587479    
Other Study ID Numbers: JAB-8263-1001
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms