A First-in-Human, JAB-8263 in Adult Patients With Advanced Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJacobio Pharmaceuticals Co., Ltd.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- JAB-8263
- JAB-8263
Treatment groups
152 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov