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

NCT ID: NCT04686682

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-07
• Study Completion Date: 2028-07-31

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

Conditions

NSCLC; SCLC; CRPC; ESCC; Ovarian Carcinoma; AML; MF; Malignant Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JAB-8263 Part1

Monotherapy, dose escalation

Group Type: EXPERIMENTAL

JAB-8263

Intervention Type: DRUG

Variable dose, orally Q2D with 28 days each cycle

JAB-8263 Part 2

Monotherapy, dose expansion

Group Type: EXPERIMENTAL

JAB-8263

Intervention Type: DRUG

RP2D dose, orally Q2D with 28 days each cycle

Interventions

JAB-8263

Variable dose, orally Q2D with 28 days each cycle

Intervention Type: DRUG

JAB-8263

RP2D 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 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

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

Tianjin

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jacobio Pharmaceuticals

Role: CONTACT

clinicaltrials@jacobiopharma.com

86 10 56315466

Other Identifiers

JAB-8263-1002

Identifier Type: -

Identifier Source: org_study_id