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

Inclusion Criteria:

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 whichhave progressed despite standard therapy or for which no standard therapy exists.
4. Subjects with life expectancy ≥3 months.
5. Patients must have at least one measurable lesion as defined by RECIST v1.1.
6. Patients who have sufficient baseline organ function.

Exclusion Criteria:

1. Severe autoimmune disease (including immune-related adverse events of priorimmune-oncology therapy) or autoimmune disorder that requires chronic systemiccorticosteroid treatment at immunosuppressive doses (prednisone >10 mg/day orequivalent).
2. Known malignant central nervous system disease other than neurologically stable,treated brain metastases.
3. History or evidence of interstitial lung disease, radiation pneumonitis which requiredsteroid treatment, or idiopathic pulmonary fibrosis, pleural or pericardial effusionthat required intervention such as a drain.
4. 8. History of seropositive status for hepatitis B, hepatitis C and humanimmunodeficiency virus (HIV).
5. History or evidence of active infections (Grade ≥2).
6. History or evidence of significant inflammatory or vascular eye disorder.
7. History of an allogeneic bone marrow or solid organ transplant.
8. Use of systemic anti-cancer agent (except for anti-androgen therapy for prostatecancer) or investigational drug ≤28 days prior to the first dose of JAB-3312.
9. History of radiation therapy ≤28 days prior to the first dose of JAB-3312, or likelyto require radiation therapy at any time until the 30 days after the last dose ofJAB-3312.
10. History of transfusion of whole blood, red blood cell or platelet packets ≤2 weeksbefore the start of treatment.
11. Subjects experiencing unresolved Grade >1 toxicity before the start of treatment.