Atridia: This phase I trial is testing repeated doses of a new drug (SHR-1316) in patients with advanced cancersA Phase 1, Open-Label, Multicenter, Non-Randomized, Dose Escalation Study to Evaluate the Safety and Tolerability of SHR-1316 in Subjects With Advanced Solid Tumors

Exclusion

Subjects who fulfill any of the following criteria at screening will be ineligible to participate in this study:

1. Known history of hypersensitivity to any components of the SHR-1316 product;
2. Any investigational or concurrent cancer therapy (including surgery, radiotherapy, immunotherapy, hormone therapy, or target therapy), administered within 4 weeks or 5 half-lives, whichever is longer, before the first dose of SHR-1316; or within 6 weeks in the case of certain therapies (e.g., extensive radiotherapy, major surgery, mitomycin C and nitrosoureas). Any such, prior systemic therapy needs to be outside of five half-lives, unless discussed and explained with the sponsor. Any AEs from prior therapy must have returned to ≤ Grade 1 CTCAE level;
3. Subjects with active, known, or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, euthyroid patients with a history of Grave's disease (subjects with suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin prior to first dose of study drug), psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
4. Active central nervous system (CNS) metastases, as indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive disease. Prior treated brain or meningeal metastases must be clinically stable (MRI) for at least 8 weeks and off immunosuppressive doses of systemic steroids (<10 mg/day prednisone or equivalent) for at least 4 weeks before study drug administration;
5. Clinically significant cardiovascular condition, including: (1) history of congestive heart failure (NYHA Class >2), (2) history of unstable angina, (3) myocardial infarction within the past 12 months, or (4) history of supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention;

6. History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful:

   • For example, a screening QTcF interval that is prolonged (>450 milliseconds [msec] in males; >470 msec in females).

7. Active infection or an unexplained fever >38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, subjects with tumor fever may be enrolled);
8. History of immunodeficiency including seropositivity for human immunodeficiency virus (HIV), or other acquired or congenital immune-deficient disease, or any active systemic viral infection requiring therapy (e.g., hepatitis B or C);
9. Any other medical (e.g., pulmonary, metabolic, congenital, endocrinal or CNS disease, etc.), psychiatric, or social condition deemed by the investigator to be likely to interfere with a subject's rights, safety, welfare or ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.