A First-in-Human, JAB-8263 in Adult Patients With Advance... | NCT04686682

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

NCT04686682

Sponsor

Jacobio Pharmaceuticals Co., Ltd.

Status

Recruiting

Last Update Posted

Jan 9, 2026Actual

Enrollment

152Estimated

Phase

Phase 1Phase 2

Conditions

NSCLC
SCLC
CRPC
ESCC
Ovarian Carcinoma
AML
MF
Malignant Tumor

Interventions

JAB-8263
JAB-8263

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 7, 2021Actual

Primary Completion Date

Jan 2028Estimated

Completion Date

Jul 2028Estimated

First Submitted Date

Dec 23, 2020

First Submission Date that Met QC Criteria

Dec 23, 2020

First Posted Date

Dec 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2026

Last Update Posted Date

Jan 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

152Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
JAB-8263 Part1	Experimental	Monotherapy, dose escalation	Drug: JAB-8263
JAB-8263 Part 2	Experimental	Monotherapy, dose expansion	Drug: JAB-8263

Interventions

Name	Type	Description	Arm Group Labels	Other Names
JAB-8263	Drug	Variable dose, orally Q2D with 28 days each cycle	JAB-8263 Part1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	Approximately 18 months

Secondary Outcomes

Measure	Description	Time Frame
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	Approximately 18 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010051	Ovarian Neoplasms
D009369	Neoplasms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D010049	Ovarian Diseases
D000291	Adnexal Diseases