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Recruiting NCT04686682

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

Phase I / Phase II Interventional NSCLC SCLC CRPC ESCC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: JAB-8263, JAB-8263.
Who it may be relevant to
Registry conditions: NSCLC, SCLC, CRPC, ESCC. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug JAB-8263
    Variable dose, orally Q2D with 28 days each cycle
  • Drug JAB-8263
    RP2D dose, orally Q2D with 28 days each cycle

Primary outcome measures

  • Number of participants with dose limiting toxicities [Time frame: Approximately 18 months]
Secondary outcome measures (11)
  • Number of participants with adverse events [Time frame: Approximately 18 months]
  • Area under the curve [Time frame: Approximately 18 months]
  • Cmax [Time frame: Approximately 18 months]
  • Tmax [Time frame: Approximately 18 months]
  • T1/2 [Time frame: Approximately 18 months]
  • Objective response rate ( ORR ) [Time frame: Approximately 18 months]
  • Duration of response ( DOR ) [Time frame: Approximately 18 months]
  • Duration of response ( DCR ) [Time frame: Approximately 18 months]
  • CR without minimal residual disease rate (CR MRD-) [Time frame: Approximately 18 months]
  • Overall response rate [Time frame: Approximately 18 months]
  • Event-free survival( EFS) [Time frame: Approximately 18 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • History of malignant biliary obstruction
  • Pregnant or breast-feeding

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tianjin — Tianjin

Identifiers

NCT: NCT04686682 · JAB-8263-1002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗