A Phase 1a Study Evaluating the Safety, Tolerability, and Efficacy of IBI322 in Subjects With Advanced Cancers

A Phase 1a study evaluating the safety, tolerability and preliminary efficacy of IBI322 in subjects with advanced malignant tumors

Inclusion criteria

• Subjects with histologically/cytologically confirmed unresectable or metastatic solid tumors or relapsed/recurrent lymphomas for which there are no available therapies known to confer clinical benefit.
• At least one evaluable lesion in Part A or at least one measurable lesion in Part B.
• Male or female subject > 18 years old.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
• Must have adequate organ function including the following.
• Subjects with life expectancy ≥ 12 weeks.
• Female subjects of childbearing age or male subjects whose partners are women at childbearing age, need to use 2 highly effective contraceptive measures, including one barrier method, throughout the treatment period and 6 months after the treatment period.
• Willing to sign informed consent form and be able to comply with the study's rules and visits/related procedures.

Exclusion criteria

• Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
• Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.
• Subjects who are on anticoagulants and/or require concomitant aspirin or other nonsteroids anti-inflammatory medications.
• Subjects who have a history of blood transfusion within 2 weeks prior to screening, or the use of erythropoietin (EPO), granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage-colony stimulating factor (GM-CSF), thrombopoietin (TPO) or IL-11 therapy.
• Subjects who received the last dose of antineoplastic therapy (chemotherapy, endocrine therapy, targeted therapy, immunotherapy or tumor embolization) within 4 weeks prior to the first dose of study drug. Subjects who received the last dose of radiotherapy within 3 weeks prior to the first dose of study drug.
• Subjects that received immunosuppressive drugs within 7 days prior to the first dose of study drug, excluding topical, intra-nasal, or inhaled glucocorticoids or systemic glucocorticoids (i.e. equivalent to no more than 10 mg prednisone/day) or other glucocorticoids of equivalent dosage through nasal spray, inhalation or other routes.
• Any ongoing AEs Grade 2 or higher as per NCI CTCAE v5.0 directly attributed to prior anti-tumor treatment with the exception of residual hair loss and fatigue
• Subjects who received whole pelvic radiotherapy prior to the enrollment.
• Subjects with known cerebrospinal metastases and other known central nervous system metastases.
• Subjects with active or suspected autoimmune diseases or with a history of documented autoimmune disease over the past 2 years (subjects can be included in the study: vitiligo, psoriasis, alopecia or Grave's disease subjects who do not require systemic treatment within 2 years; hypothyroidism subjects who require only thyroid hormone replacement therapy, and type I diabetes subjects who require only insulin replacement therapy).
• Known history of primary immunodeficiency.
• Known history of active pulmonary tuberculosis.
• Known history of allogenic organ transplantation and hematopoietic stem cell transplantation.
• Known history of hypersensitivity to any components of the IBI322 injection.