A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors (NCT04045496) | Clinical Trial Compass
CompletedPhase 1
A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors
United States40 participantsStarted 2019-09-26
Plain-language summary
This is a Phase 1, first-in-human, open-label dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and assess the DLT of JAB-3312. It is anticipated that approximately 24 subjects will be enrolled in the dose-escalation phase of the study. JAB-3312 will be administered orally once daily (QD) in 21-day treatment cycles.
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 or for which no standard therapy exists.
✓. Subjects with life expectancy ≥3 months.
✓. Patients must have at least one measurable lesion as defined by RECIST v1.1.
✓. Patients who have sufficient baseline organ function.
Exclusion criteria
✕. Severe autoimmune disease (including immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone \>10 mg/day or equivalent).
✕. Known malignant central nervous system disease other than neurologically stable, treated brain metastases.
✕. History or evidence of interstitial lung disease, radiation pneumonitis which required steroid treatment, or idiopathic pulmonary fibrosis, pleural or pericardial effusion that required intervention such as a drain.
✕. 8\. History of seropositive status for hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
✕. History or evidence of active infections (Grade ≥2).
What they're measuring
1
Number of participants with dose limiting toxicities
✕. History or evidence of significant inflammatory or vascular eye disorder.
✕. History of an allogeneic bone marrow or solid organ transplant.
✕. Use of systemic anti-cancer agent (except for anti-androgen therapy for prostate cancer) or investigational drug ≤28 days prior to the first dose of JAB-3312.