A First-in-Human Study of JAB-8263 in Adult Patients With Advanced Solid Tumors

NCT ID: NCT04587479

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-23
• Study Completion Date: 2024-10-31

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JAB-8263

Monotherapy, dose escalation

Group Type: EXPERIMENTAL

JAB-8263

Intervention Type: DRUG

Variable dose, orally Q2D with 28 days each cycle

Interventions

JAB-8263

Variable dose, orally Q2D with 28 days each cycle

Intervention Type: DRUG

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 life expectancy ≥3 months.

5. Patients must have at least one measurable lesion as defined by RECIST v1.1.

6. 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

11. History of myocardial infarction, unstable angina pectoris, coronary artery bypass graft, or cerebrovascular accident

12. Impaired cardiac function or clinically significant cardiac diseases

13. QTcF >470 msec at screening

14. History of medically significant thromboembolic events or bleeding diathesis

15. Unresolved Grade >1 toxicity

16. History of malignant biliary obstruction

17. Pregnant or breast-feeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jacobio Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacobio Pharmaceuticals

Role: STUDY_DIRECTOR

Jacobio Pharmaceuticals

Locations

SCRI HeatlthONE

Denver, Colorado, United States

Florida Cancer Center, Lake Mary

Lake City, Florida, United States

Tennessee Oncology Nashville

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

JAB-8263-1001

Identifier Type: -

Identifier Source: org_study_id