A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors (NCT04686682) | Clinical Trial Compass
RecruitingPhase 1/2
A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors
China152 participantsStarted 2021-05-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
What they're measuring
1
Number of participants with dose limiting toxicities