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CompletedNCT04587479Updated Jan 13, 2026

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

A Phase 1 interventional study of JAB-8263 in Solid Tumors, Adult, sponsored by Jacobio Pharmaceuticals Co., Ltd.. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-13.

Sponsored by Jacobio Pharmaceuticals Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Oct 2024, 1 year 11 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
41
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Solid Tumors, Adult

Keywords

  • BET inhibitor
  • Bromodomain and Extra-terminal
03

In context

Lead sponsor

Jacobio Pharmaceuticals Co., Ltd. is the lead sponsor of 14 studies on the registry; 7 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    JAB-8263

    Monotherapy, dose escalation

    Drug: JAB-8263

Interventions

  • DrugJAB-8263

    Variable dose, orally Q2D with 28 days each cycle

06

What researchers measure

Primary outcomes

  1. Number of participants with dose limiting toxicities

    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

    Time frame: Approximately 2.5 years

  2. Find Recommended Phase 2 Dose (RP2D) of JAB-8263

    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)

    Time frame: Approximately 2.5 years

Secondary outcomes

  1. Number of participants with adverse events

    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

    Time frame: Approximately 2.5 years

  2. Area under the curve

    Area under the plasma concentration time curve of JAB-8263

    Time frame: Approximately 2.5 years

  3. Cmax

    Highest observed plasma concentration of JAB-8263

    Time frame: Approximately 2.5 years

  4. Tmax

    Time of highest observed plasma concentration of JAB-8263

    Time frame: Approximately 2.5 years

  5. T1/2

    Half life of JAB-8263

    Time frame: Approximately 2.5 years

  6. Objective response rate ( ORR )

    ORR is defined as the proportion of participants with complete response or partial response (CR+PR)

    Time frame: Approximately 2.5 years

  7. Duration of response ( DOR )

    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.

    Time frame: Approximately 2.5 years

07

Study locations

3 sites
  • SCRI HeatlthONE
    Denver, Colorado 80218, United States
  • Florida Cancer Center, Lake Mary
    Lake City, Florida 32025, United States
  • Tennessee Oncology Nashville
    Nashville, Tennessee 37203, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04587479
Lead sponsor
Jacobio Pharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Oct 14, 2020
Start date
Nov 23, 2020
Primary completion
Oct 31, 2024
Completion
Oct 31, 2024
Last update
Jan 13, 2026

Study contacts

Jacobio Pharmaceuticals
study director · Jacobio Pharmaceuticals

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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