Recruiting
Phase 1/2
A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors
Condition(s) studied
NSCLCSCLCCRPCESCCOvarian CarcinomaAMLMFMalignant Tumor
Investigational drug(s) / intervention(s)
JAB-8263: Variable dose, orally Q2D with 28 days each cycle
JAB-8263: RP2D dose, orally Q2D with 28 days each cycle
Study 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 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
Primary outcome measure(s)
- Number of participants with dose limiting toxicities — Approximately 18 months
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
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Tianjin |
Tianjin |
Tianjin Municipality |
Recruiting |
More Jacobio Pharmaceuticals Co., Ltd. trials in China
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