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

  • STATUS
    Recruiting
  • days left to enroll
    26
  • participants needed
    152
  • sponsor
    Jacobio Pharmaceuticals Co., Ltd.
Updated on 3 August 2021
measurable disease
refractory acute myeloid leukemia (aml)
solid tumor

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.

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

Details
Condition nsclc, Cancer, malignant tumors, Squamous Cell Carcinoma of Esophagus, malignant tumor, small cell carcinoma, ovarian carcinomas, malignancies, ovarian epithelial carcinoma, Non-Small Cell Lung Cancer, carcinoma of the ovary, Mycosis Fungoides, Acute myeloid leukemia, Cancer/Tumors, Oat cell carcinoma, ovarian carcinoma, Ovarian Cancer, anll, Esophageal Squamous Cell Carcinoma, Neoplasms, malignancy, Comoros, Castration-Resistant Prostate Cancer, Ewing's Family Tumors, cancer of the ovary, Castration-Resistant Prostate Carcinoma, CRPC, Acute Myeloid Leukemia, cancer ovarian, small cell carcinoma of the lung, Recurrent Ovarian Cancer, Epithelial Ovarian Carcinoma, acute myelogenous leukemia, Acute Myelogenous Leukemia (AML), sclc, Small Cell Lung Cancer, Cancer (Pediatric), small cell carcinomas, cancers, cancer, ovarian, acute myeloblastic leukemia
Treatment JAB-8263
Clinical Study IdentifierNCT04686682
SponsorJacobio Pharmaceuticals Co., Ltd.
Last Modified on3 August 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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