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History of Changes for Study: NCT04587479
A First-in-Human, Phase 1 Study of JAB-8263 in Adult Patients With Advanced Solid Tumors
Latest version (submitted March 11, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 9, 2020 None (earliest Version on record)
2 October 13, 2020 Study Status and Study Identification
3 November 30, 2020 Recruitment Status, Study Status and Contacts/Locations
4 March 11, 2022 Study Status
Comparison Format:

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Study NCT04587479
Submitted Date:  October 9, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: JAB-8263-1001
Brief Title: A First-in-Human, Phase 1 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
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2020
Overall Status: Not yet recruiting
Study Start: October 30, 2020
Primary Completion: April 30, 2022 [Anticipated]
Study Completion: April 30, 2023 [Anticipated]
First Submitted: October 9, 2020
First Submitted that
Met QC Criteria:
October 9, 2020
First Posted: October 14, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
October 9, 2020
Last Update Posted: October 14, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Jacobio Pharmaceuticals Co., Ltd.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
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

Open or close this module Conditions
Conditions: Solid Tumors, Adult
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 30 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: JAB-8263
Monotherapy, dose escalation
Drug: JAB-8263
Variable dose, orally Q2D with 28 days each cycle
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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
Open or close this module Contacts/Locations
Central Contact Person: Jacobio Pharmaceuticals
Telephone: 86 10 56315466
Email: clinicaltrials@jacobiopharma.com
Study Officials: Jacobio Pharmaceuticals
Study Director
Jacobio Pharmaceuticals
Locations: United States, Colorado
SCRI HeatlthONE
Denver, Colorado, United States, 80218
Contact:Contact: Gerald Falchook, MD
United States, Florida
Florida Cancer Center, Lake Mary
Lake City, Florida, United States, 32025
Contact:Contact: Shekeab Jauhari, MD
United States, Tennessee
Tennessee Oncology Nashville
Nashville, Tennessee, United States, 37203
Contact:Contact: James M Pauff, MD PhD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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