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

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.

Study Overview

• Status: Recruiting
• Conditions: NSCLC; AML; SCLC; Ovarian Carcinoma; Malignant Tumor; ESCC; CRPC; MF
• Intervention / Treatment: Drug: JAB-8263; Drug: JAB-8263

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

• Study Type: Interventional
• Enrollment (Estimated): 152
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jacobio Pharmaceuticals; Phone Number: 86 10 56315466; Email: clinicaltrials@jacobiopharma.com

Study Locations

• China
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300020
      • Recruiting
      • Tianjin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JAB-8263 Part1; Monotherapy, dose escalation	Drug: JAB-8263; Variable dose, orally Q2D with 28 days each cycle; Drug: JAB-8263; RP2D dose, orally Q2D with 28 days each cycle
Experimental: JAB-8263 Part 2; Monotherapy, dose expansion	Drug: JAB-8263; Variable dose, orally Q2D with 28 days each cycle; Drug: JAB-8263; RP2D dose, orally Q2D with 28 days each cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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
Area under the curve	Area under the plasma concentration time curve of JAB-8263	Approximately 18 months
Cmax	Highest observed plasma concentration of JAB-8263	Approximately 18 months
Tmax	Time of highest observed plasma concentration of JAB-8263	Approximately 18 months
T1/2	Half life of JAB-8263	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)	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.	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).	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.	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).	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.	Approximately 18 months

Collaborators and Investigators

• Sponsor: Jacobio Pharmaceuticals Co., Ltd.
• Investigators: Study Director: Jacobio Pharmaceuticals, Jacobio Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2021
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: December 23, 2020
• First Submitted That Met QC Criteria: December 23, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: BET inhibitor; Bromodomain and Extra-terminal
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Neoplasms; Ovarian Neoplasms
• Other Study ID Numbers: JAB-8263-1002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No