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
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Among 392 studies in Ovarian Neoplasms with a site in China — 198 open to participants now, 231 under way, 35 of them phase 3. Ovarian Neoplasms · China.
Among the 392 studies in Ovarian Neoplasms with a site in China, this one is the 101st largest by planned enrollment of the 319 interventional ones that give a count, is one of 44 that started in 2021, is one of 53 in phase 1/2, reaches primary completion later than 173 of the 230 other live ones, and was the 114th registered.
3,385 studies on the registry are indexed under Ovarian Neoplasms; 792 are open to participants now.
Browse Ovarian Neoplasms studies →198 of the 392 studies in Ovarian Neoplasms with a site in China are open now. Recruiting first, the newest first:
Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Sites in China
Ages 18+ · Women only
Chinese PLA General Hospital · Sites in China
Ages 18–75 · Women only
Catherin Zhang · Sites in China
Ages 18–75 · Women only
Phrontline Biopharma · Sites in China, United States
Ages 18+
AstraZeneca · Sites in China, United States, Australia and 10 more countries
Ages 18+ · Women only
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 605 Ovarian Neoplasms studies recruiting now, 442 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
392 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 123 · Phase 2 164 · Phase 3 57 · Phase 4 3
First in 2005; this study’s year is marked. 44 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 152 is above the median of 54 across 2,552 interventional studies indexed under Ovarian Neoplasms.
Median enrollment 83 across the 319 interventional studies, 200 across the 73 observational. Of the 74 that completed or were terminated, 11 (15%) have results posted.
This tab as a report to print or save as PDF → With an account.
154 of 392 have an industry lead sponsor. The 10 most frequent:
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.
Jacobio Pharmaceuticals Co., Ltd. has 2 studies filed under Ovarian Neoplasms — fewer than ten, so there is no comparison to draw.
63 of the studies in Ovarian Neoplasms with a site in China that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06855069Phase 3Hansoh BioMedical R&D CompanyHS-20089 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer | 2027-03-07 |
| NCT05445778Phase 3AbbVieMirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer | 2027-04 |
| NCT04421963Phase 3AstraZenecaRoll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib | 2027-04-06 |
| NCT06828354Phase 3Jiangsu HengRui Medicine Co., Ltd.A Study of SHR-A1811 in Subjects With Ovarian Cancer | 2027-05 |
| NCT07604766Phase 3GenmabAn Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer in China | 2027-09 |
Add all 63 to your calendar (.ics) → With an account.
Among the 392 studies in Ovarian Neoplasms with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects must meet all the following criteria in order to be included in the research study:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Monotherapy, dose escalation
Drug: JAB-8263
Monotherapy, dose expansion
Drug: JAB-8263
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
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
Area under the curve
Area under the plasma concentration time curve of JAB-8263
Time frame: Approximately 18 months
Cmax
Highest observed plasma concentration of JAB-8263
Time frame: Approximately 18 months
Tmax
Time of highest observed plasma concentration of JAB-8263
Time frame: Approximately 18 months
T1/2
Half life of JAB-8263
Time frame: Approximately 18 months
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
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
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
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
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
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
Plan to share: No
No publications or documents are linked to this record.
Started May 2021 (actual). Primary completion is estimated for Jan 2028, 80 months after the start.
Of 116 industry-sponsored phase 1/2 interventional studies under Ovarian Neoplasms, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 44 and three quarters within 88. This study's planned 80 months is above that.
Counting every sponsor, half of 173 studies reached it within 65 months; a quarter within 44 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: BET Inhibitor JAB-8263
Jacobio Pharmaceuticals Co., Ltd.