A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors

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).
• 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.
• History of radiation therapy ≤28 days prior to the first dose of JAB-3312, or likely to require radiation therapy at any time until the 30 days after the last dose of JAB-3312.
• History of transfusion of whole blood, red blood cell or platelet packets ≤2 weeks before the start of treatment.
• Subjects experiencing unresolved Grade >1 toxicity before the start of treatment.