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NSCLCPhase 1/2NCT04686682

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

A Phase 1/2 study testing JAB-8263 in people with NSCLC and SCLC, run by Jacobio Pharmaceuticals Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC, SCLC, CRPC
What is being tested?
JAB-8263
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
1 siteChina
Study dates
7 May 2021to Jul 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all the following criteria in order to be included in the research study:
  • Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • 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.
  • Subjects with recurrent/refractory AML according to WHO 2016
  • Subjects with life expectancy ≥3 months.
  • Patients with solid tumor must have at least one measurable lesion as defined by RECIST v1.1.
  • Patients who have sufficient baseline organ function.

Who cannot join

  • History (≤3 years) of cancer that is histologically distinct from the cancer under study.
  • Known serious allergy to investigational drug or excipients
  • Active brain or spinal metastases
  • History of pericarditis or Grade ≥2 pericardial effusion
  • History of interstitial lung disease.
  • History of Grade ≥2 active infections within 2 weeks
Show all 17Show fewer
  • Known human immunodeficiency virus (HIV) infection
  • Seropositive for hepatitis B virus (HBV)
  • Seropositive for hepatitis C virus (HCV), or HCV-RNA viral levels are not detectable.
  • Any severe and/or uncontrolled medical conditions
  • History of myocardial infarction, unstable angina pectoris, coronary artery bypass graft, or cerebrovascular accident
  • Impaired cardiac function or clinically significant cardiac diseases
  • QTcF >470 msec at screening
  • History of medically significant thromboembolic events or bleeding diathesis
  • Unresolved Grade >1 toxicity
  • History of malignant biliary obstruction
  • Pregnant or breast-feeding

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jacobio Pharmaceuticals contact

86 10 56315466

clinicaltrials@jacobiopharma.com

China1 site, 1 recruiting

  • Tianjin

    Tianjin, Tianjin Municipality, 300020

    Recruiting

Other trials in China

About this study

Official title: A Phase I/IIa, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-8263 in Adult Patients With Advanced Malignant Tumors

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

Being tested
JAB-8263
Keywords
BET inhibitor, Bromodomain and Extra-terminal
Medical subject headings
Ovarian Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JAB-8263Drug

    Variable dose, orally Q2D with 28 days each cycle

  • JAB-8263Drug

    RP2D dose, orally Q2D with 28 days each cycle

Study groups in NCT04686682
Study groupRoleWhat they receive
JAB-8263 Part1ExperimentalMonotherapy, dose escalation
Receives: Drug: JAB-8263
JAB-8263 Part 2ExperimentalMonotherapy, dose expansion
Receives: Drug: JAB-8263

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Approximately 18 months

Secondary outcomes (11)

  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

    Measured: Approximately 18 months

  2. Area under the curve

    Area under the plasma concentration time curve of JAB-8263

    Measured: Approximately 18 months

  3. Cmax

    Highest observed plasma concentration of JAB-8263

    Measured: Approximately 18 months

  4. Tmax

    Time of highest observed plasma concentration of JAB-8263

    Measured: Approximately 18 months

  5. T1/2

    Half life of JAB-8263

    Measured: 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)

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: Approximately 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2020
  2. Study start7 May 2021
  3. Primary completionJan 2028 (estimated)
  4. Study completionJul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
152 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04686682
Sponsor's protocol ID
JAB-8263-1002
Status last verified
Jan 2026
First submitted
23 Dec 2020
Last updated
9 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing JAB-8263 in people with NSCLC and SCLC, run by Jacobio Pharmaceuticals Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jacobio Pharmaceuticals (86 10 56315466, clinicaltrials@jacobiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with dose limiting toxicities (time frame: Approximately 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04686682.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.

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