Advanced Solid Tumors and Hematologic Malignancies
Conditions
Brief summary
This is a nonrandomized, open-label, multicenter, phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of CM369 in subjects with advanced solid tumors and Hematologic Malignancies.
Interventions
DRUGCM369
Specified dose on specified days.
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Solid tumor Inclusion Criteria: 1. Life expectancy ≥12 weeks. 2. Eastern Cooperative Oncology Group performance status of 0-1. 3. Subjects with cytology and/or histologically confirmed locally advanced unresectable or metastatic solid tumors. 4. Agree to provide archived tumor tissue samples of primary or metastatic lesions. 5. Phase Ia: have at least one measurable lesion or one evaluable lesion according to RECIST 1.1. 6. Have adequate organ function as described in the protocol. Hematologic Malignancies Inclusion Criteria: 1. Male and female subjects ≥18 years of age and ≤ 75 years of age. 2. This study enroll subjects with recurrent/refractory hematological tumors. 3. The subjects must have measurable lesions. 4. Positive CCR8in tumor tissues of subjects. 5. Eastern Cooperative Oncology Group performance status (ECOG) of ≤2, and had a Life expectancy of at least 3 months. 6. Adequate hematological function, defined as protocol. 7. Subjects with normal coagulation function, defined as protocol. 8. Adequate hepatic, renal and cardiac functions, defined as protocol. 9. Subjects voluntarily signed informed consent form (ICF) and written informed consent must be obtained prior to performing any study-related procedure. 10. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to receiving the first dose of study medication. 11. WOCBP or male subjects and their female partners of childbearing potential must be willing to use an appropriate method of contraception during the study and for 6 months after the last dose, and must not donate eggs or sperms during this period. 12. Female subjects were not allowed to breastfeed during the study and for at least 6 months after the last dose of study medication.
Exclusion criteria
Solid tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AEs) | 90 weeks |
| Serious Adverse events (SAEs) | 90 weeks |
| Dose limiting toxicities (DLTs) | 90 weeks |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters: Clearance (CL) | 90 weeks |
| PK parameter: Peak Time (Tmax) | 90 weeks |
| Immunogenicity: Incidence of anti-CM369 antibody | 90 weeks |
| PK parameter: Apparent volume of distribution of steady state (Vss) | 90 weeks |
| PK parameter: Half-life (t1/2) | 90 weeks |
| PK parameter: Area Under the Curve (AUC) | 90 weeks |
Countries
China
Contacts
Primary ContactRuihua Xu
Outcome results
None listed