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A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

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

NCT04686682•Jacobio Pharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

•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
+7 more criteria

Locations (1)

Tianjin

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

May 7, 2021

Primary Completion Date

January 1, 2028

Completion Date

July 1, 2028

Last Updated

January 9, 2026

Enrollment

152

ESTIMATED participants

Conditions

NSCLCSCLCCRPCESCCOvarian CarcinomaAMLMFMalignant Tumor

Interventions

JAB-8263

DRUG

JAB-8263

DRUG

Contacts

Jacobio Pharmaceuticals

CONTACT

86 10 56315466 clinicaltrials@jacobiopharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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