Solid Tumors, AdultPhase 1NCT04587479
A First-in-Human Study of JAB-8263 in Adult Patients With Advanced Solid Tumors
A Phase 1 study testing JAB-8263 in people with Solid Tumors, Adult, run by Jacobio Pharmaceuticals Co., Ltd. at 3 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Adult
- 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
- 41 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Nov 2020to 31 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 life expectancy ≥3 months.
- Patients 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
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- 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
3 sites in 1 country.
United States3 sites
SCRI HeatlthONE
Denver, Colorado, 80218
Florida Cancer Center, Lake Mary
Lake City, Florida, 32025
Tennessee Oncology Nashville
Nashville, Tennessee, 37203
About this study
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
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
- Conditions
- Solid Tumors, Adult
- Being tested
- JAB-8263
- Keywords
- BET inhibitor, Bromodomain and Extra-terminal
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
| Study group | Role | What they receive |
|---|---|---|
| JAB-8263 | Experimental | Monotherapy, dose escalation Receives: Drug: JAB-8263 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 2.5 years
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)
Measured: Approximately 2.5 years
Secondary outcomes (7)
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 2.5 years
Area under the curve
Area under the plasma concentration time curve of JAB-8263
Measured: Approximately 2.5 years
Cmax
Highest observed plasma concentration of JAB-8263
Measured: Approximately 2.5 years
Tmax
Time of highest observed plasma concentration of JAB-8263
Measured: Approximately 2.5 years
T1/2
Half life of JAB-8263
Measured: Approximately 2.5 years
Objective response rate ( ORR )
ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Measured: Approximately 2.5 years
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.
Measured: Approximately 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start23 Nov 2020
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacobio Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacobio Pharmaceuticals, Study director, Jacobio Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587479
- Sponsor's protocol ID
- JAB-8263-1001
- Status last verified
- Jan 2026
- First submitted
- 9 Oct 2020
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04587479
- Acronym / sponsor ID
- JAB-8263-1001
- Conditions
- Solid Tumors, Adult
- Keywords
- BET inhibitor, Bromodomain and Extra-terminal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Jacobio Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Nov 2020 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JAB-8263 | Experimental | Drug: JAB-8263Monotherapy, dose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 life expectancy ≥3 months.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JAB-8263Variable dose, orally Q2D with 28 days each cycle | Drug | JAB-8263 |
Primary outcome
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
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)
7 secondary outcomes
Number of participants with adverse events
Time frame: Approximately 2.5 years
Area under the curve
Time frame: Approximately 2.5 years
Cmax
Time frame: Approximately 2.5 years
Tmax
Time frame: Approximately 2.5 years
T1/2
Time frame: Approximately 2.5 years
Objective response rate ( ORR )
Time frame: Approximately 2.5 years
Duration of response ( DOR )
Time frame: Approximately 2.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacobio Pharmaceuticals study director
Jacobio Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JAB-8263 in people with Solid Tumors, Adult, run by Jacobio Pharmaceuticals Co., Ltd. at 3 sites in United States.
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 7 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: finished, as of the sponsor's last update on 13 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 3 sites in United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose limiting toxicities (time frame: Approximately 2.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2026.