A Study Evaluating the Safety, Tolerance and Anti-tumor Activity of HBM1020 in Subjects With Advanced Solid Tumors

This is a study to evaluate the safety and tolerability of the study drug HBM1020, and to determine the maximum tolerated dose and/or recommended Phase 2 study dose of HBM1020. The study will also look at the anti-tumor activity of HBM1020.The study consists of 2 parts. In Part 1, patients are enrolled into different cohort doses in order to identify the appropriate recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD). In Part 2, participants with metastatic/unresectable RCC, CRC will receive the MTD and/or RP2D established in Part 1 of the study. In Part 1 and Part 2, participants will be administered treatment every 3 weeks.

Inclusion criteria

• Willingness to sign a written informed consent document.
• Male or female subject aged ≥18 years old at the time of screening.
• Histologically or cytologically confirmed advanced solid tumors or recurrent and progressed since last antitumor therapy for which no alternative, curative standard therapy exists.
• Adequate organ and bone marrow function.

Exclusion criteria

• Prior used anti-B7H7 monoclonal antibodies (mAb) or anti-KIR3DL3 monoclonal antibodies (mAb).
• Any systemic anti-cancer therapy within 4 weeks prior to first dose of investigational medicinal product (IMP), or immunosuppressive medications within 2 weeks before the first dose of investigational medicinal product (IMP).
• Not yet recovered from surgery or (immune-related) toxicity related with previous treatment.
• With clinically significant congenital or acquired cardiovascular diseases.
• With severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection including hepatitis B, hepatitis C, autoimmune disease and human immunodeficiency virus.
• Presence of other active invasive cancers other than the one treated in this study within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, or in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment.
• Major surgery (excluding placement of vascular access) within 4 weeks of first dose of study drug.
• Previously untreated brain metastases.
• Pregnant or breastfeeding women.