Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM369 Ia Dose Escalation | Experimental | Dose escalation of CM369 as monotherapy |
|
| CM369 Ib Dose Expansion | Experimental | Dose expansion of CM369 as monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM369 | Drug | Specified dose on specified days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | 90 weeks | |
| Serious Adverse events (SAEs) | 90 weeks | |
| Dose limiting toxicities (DLTs) | 90 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameter: Peak Time (Tmax) | 90 weeks | |
| PK parameter: Half-life (t1/2) | 90 weeks | |
| PK parameter: Area Under the Curve (AUC) |
Not provided
Inclusion Criteria:
Solid tumor Inclusion Criteria:
Hematologic Malignancies Inclusion Criteria:
Exclusion Criteria:
Solid tumor Exclusion Criteria:
Hematologic Malignancies Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruihua Xu | Contact | 13922296676 | xurh@sysucc.org.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 90 weeks |
| PK parameters: Clearance (CL) | 90 weeks |
| PK parameter: Apparent volume of distribution of steady state (Vss) | 90 weeks |
| Immunogenicity: Incidence of anti-CM369 antibody | 90 weeks |
| Jilin Cancer Hospital | Recruiting | Changchun | Jilin | 130000 | China |
|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
|
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided