NCT04686682

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P75+ for phase_1

Timeline
26mo left

Started May 2021

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
May 2021Jul 2028

First Submitted

Initial submission to the registry

December 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

May 7, 2021

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

January 9, 2026

Status Verified

January 1, 2026

Enrollment Period

6.7 years

First QC Date

December 23, 2020

Last Update Submit

January 8, 2026

Conditions

NSCLCSCLCCRPCESCCOvarian CarcinomaAMLMFMalignant Tumor

Keywords

BET inhibitorBromodomain and Extra-terminal

Outcome Measures

Primary Outcomes (1)

  • 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 (11)

  • Number of participants with adverse events

    Approximately 18 months

  • Area under the curve

    Approximately 18 months

  • Cmax

    Approximately 18 months

  • Tmax

    Approximately 18 months

  • T1/2

    Approximately 18 months

  • +6 more secondary outcomes

Study Arms (2)

JAB-8263 Part1

EXPERIMENTAL

Monotherapy, dose escalation

Drug: JAB-8263

JAB-8263 Part 2

EXPERIMENTAL

Monotherapy, dose expansion

Drug: JAB-8263

Interventions

JAB-8263DRUG

Variable dose, orally Q2D with 28 days each cycle

JAB-8263 Part1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must meet all the following criteria in order to be included in the research study:
  • Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • 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.
  • Subjects with recurrent/refractory AML according to WHO 2016
  • Subjects with life expectancy ≥3 months.
  • Patients with solid tumor must have at least one measurable lesion as defined by RECIST v1.1.
  • Patients who have sufficient baseline organ function.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Ovarian NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Jacobio Pharmaceuticals

    Jacobio Pharmaceuticals

    STUDY DIRECTOR

Central Study Contacts

Jacobio Pharmaceuticals

CONTACT

86 10 56315466clinicaltrials@jacobiopharma.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2020

First Posted

December 29, 2020

Study Start

May 7, 2021

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

January 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)