CClinicalTrials.gg
Sign In
RecruitingNCT04686682Updated Jan 9, 2026

A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors

A Phase 1/2 interventional study of JAB-8263 and JAB-8263 in NSCLC, SCLC and CRPC, sponsored by Jacobio Pharmaceuticals Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-09.

Sponsored by Jacobio Pharmaceuticals Co., Ltd. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
152
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a Phase 1/2a, first-in-human, open-label study of JAB-8263, this study has two parts: solid tumor dose escalation and expansion study and hematology tumor dose escalation and expansion study.

These two parts will determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and assess the DLT of JAB-8263 in treatment with patients with advanced solid tumors and hematology tumors separately. 30 subjects each 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 malignant 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

  • NSCLC
  • SCLC
  • CRPC
  • ESCC
  • Ovarian Carcinoma
  • AML
  • MF
  • Malignant Tumor

Keywords

  • BET inhibitor
  • Bromodomain and Extra-terminal
03

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 recurrent/refractory AML according to WHO 2016
    5. Subjects with life expectancy ≥3 months.
    6. Patients with solid tumor must have at least one measurable lesion as defined by RECIST v1.1.
    7. 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
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
152 participants (estimated)

Study arms

  • Experimental
    JAB-8263 Part1

    Monotherapy, dose escalation

    Drug: JAB-8263

  • Experimental
    JAB-8263 Part 2

    Monotherapy, dose expansion

    Drug: JAB-8263

Interventions

  • DrugJAB-8263

    Variable dose, orally Q2D with 28 days each cycle

  • DrugJAB-8263

    RP2D dose, orally Q2D with 28 days each cycle

05

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 18 months

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 18 months

  2. Area under the curve

    Area under the plasma concentration time curve of JAB-8263

    Time frame: Approximately 18 months

  3. Cmax

    Highest observed plasma concentration of JAB-8263

    Time frame: Approximately 18 months

  4. Tmax

    Time of highest observed plasma concentration of JAB-8263

    Time frame: Approximately 18 months

  5. T1/2

    Half life of JAB-8263

    Time frame: Approximately 18 months

  6. Objective response rate ( ORR )

    For solid tumor study part, ORR is defined as the proportion of participants with complete response or partial response (CR+PR)

    Time frame: Approximately 18 months

  7. Duration of response ( DOR )

    For solid tumor study part, 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 18 months

  8. Duration of response ( DCR )

    For solid tumor study part, DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD).

    Time frame: Approximately 18 months

  9. CR without minimal residual disease rate (CR MRD-)

    hematology study part, CR MRD- is defined as proportion of participants with complete response without minimal residual disease.

    Time frame: Approximately 18 months

  10. Overall response rate

    For hematology study part, Overall response rate is defined as proportion of participants with complete response(CR or CRi), partial remission(PR) or morphologic leukemia-free state(MLFS).

    Time frame: Approximately 18 months

  11. Event-free survival( EFS)

    For hematology study part, EFS is defined for all patients with AML, measured from the date of entry into the study to the date of primary refractory disease, or relapse from CR, or Cri, or death from any cause.

    Time frame: Approximately 18 months

06

Study locations

1 of 1 sites recruiting
  • Tianjin
    Tianjin, Tianjin Municipality 300020, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04686682
Lead sponsor
Jacobio Pharmaceuticals Co., Ltd.
Responsible party
Sponsor
First posted
Dec 29, 2020
Start date
May 7, 2021
Primary completion
Jan 2028 (estimated)
Completion
Jul 2028 (estimated)
Last update
Jan 9, 2026

Study contacts

Jacobio Pharmaceuticals
Contact
clinicaltrials@jacobiopharma.com
86 10 56315466
Jacobio Pharmaceuticals
study director · Jacobio Pharmaceuticals

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Ovarian Neoplasms→

Other studies from this sponsor

Jacobio Pharmaceuticals Co., Ltd.

Start the discussion