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
Jacobio Pharmaceuticals Co., Ltd.
152 participants
May 7, 2021
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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 Criteria17
- 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
Interventions
Variable dose, orally Q2D with 28 days each cycle
RP2D dose, orally Q2D with 28 days each cycle
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04686682