A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor

PHASE 2 STUDY OF IMC-001 IN PATIENTS WITH METASTATIC OR LOCALLY ADVANCED TMB-H SOLID TUMOR

The goal of this clinical trial is to determine the efficacy of IMC-001 in metastatic or locally advanced TMB-H solid tumor patients.

Inclusion Criteria:

1. Documented TMB-H:≥ 16 mut/Mb, determined by the TruSightTM Oncology 500 NGS panel or OncomineTM Comprehensive Assay Plus

2. Histologically or cytologically proven metastatic or locally advanced solid tumors.The participant must have at least one measurable tumor lesion per RECIST 1.1.

3. Investigator has confirmation that participant's tumor tissue is available to be submitted to a central pathology laboratory.

4. Adult age(as defined by respective country)

5. The nature of the study and voluntarily sign an ICF

6. ECOG 0 or1

7. Prior systemic radiation therapy must be completed at least 4 weeks before the first dose of study drug. Prior focal radiotherapy must be completed at least 2 weeks before the first dose of study drug.

8. At the time of the first dose of study drug at least 28 days since the last chemotherapy, immunotherapy, biological or investigational therapy, and have recovered from toxicities associated with such treatment to < Grade 2.

9. Adequate hematologic function, hepatic function, and renal function

10. Female participants must meet one of the following criteria:

    • Postmenopausal (≥24 months, or ≥12 months with FSH > 40 IU/L),
    • surgically incapable of bearing children (i.e., has had a hysterectomy or bilateral oophorectomy); or
    • females of childbearing potential must agree to use a reliable form of contraceptive during the study treatment period and for at least 90 days following the last dose of study drug.

11. Male participants must agree to use barrier contraception (i.e., condoms) for the duration of the study and for at least 90 days after the last dose of study drug.

12. Predicted life expectancy of at least 16 weeks.

Exclusion Criteria:

1. Previously treated with an anti-PD-L1 or anti-PD-1 antibody
2. Known presence of symptomatic CNS metastases
3. Any active autoimmune disease or a documented history of autoimmune disease
4. Apparent active and known viral infection with HIV, hepatitis B virus or hepatitis C virus
5. Pregnant or lactating