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This is a phase I, open-label, first-in-human study of CS08399, comprising two phases: dose escalation (including single-dose and multiple-dose) and cohort expansion. The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of CS08399 in participants with MTAP-deleted solid tumors and Lymphoma, and to recommended Phase 2 dose(s) (RP2D) of CS08399 in appropriate tumor(s).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CS08399 | Experimental | two phases: dose escalation and cohort expansion. The dose escalation part is further divided into single-dose and multiple-dose administration. In the cohort expansion part, only multiple doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS08399 | Drug | Oral tablet. Only one dose on C0D1 in single-dose period. Once or twice daily from C1D1 until disease progression, death, intolerable toxicity, loss to follow-up, withdrawal of informed consent, or the end of the trial, whichever occurs first, in multiple-dose period in both escalation and cohort expansion phases. |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of dose-limiting toxicity (DLT) | 34 days after, that is 6 days after single-dose and 28 days after first administration in multiple-dose | |
| maximum tolerated dose (MTD) | dose escalation part, up to approximately 2 year | |
| incidence of adverse events (AEs) | Number of participants with AE(s) | from first administration to 28 days after last administration or next anti-tumor therapy, whichever occurs first |
| Pharmacokinetic parameters: Time to Maximum Concentration (Tmax) | during treatment, up to approximately 2 year | |
| Pharmacokinetic parameters: Maximum Concentration (Cmax) | during treatment, up to approximately 2 year | |
| Pharmacokinetic parameters: Area Under the Concentration-time Curve(AUC) | during treatment, up to approximately 2 year | |
| Pharmacokinetic parameters: Trough Concentration (Ctrough) | during treatment, up to approximately 2 years | |
| Pharmacokinetic parameters: Accumulation Ratio (Rac) | during treatment, up to approximately 2 years | |
| Pharmacokinetic parameters: Elimination Half-life (t1/2) | during treatment, up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Up to approximately 4 years | |
| Disease control rate (DCR) | Up to approximately 4 years | |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuelian Zhou | Contact | 028-64907337 | zhouxuelian@chipscreen.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008223 | Lymphoma |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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|
| Pharmacokinetic parameters: Clearance over Fractional Bioavailability (CL/F) | during treatment, up to approximately 2 years |
| Pharmacokinetic parameters: Volume of Distribution at Steady State over Fractional Bioavailability (Vz/F) | during treatment, up to approximately 2 years |
| Up to approximately 4 years |
| Time to Progression (TTP) | Up to approximately 4 years |
| Time to Response (TTR) | Up to approximately 4 years |
| progression-free survival (PFS) | Up to approximately 4 years |
| Overall Survival (OS) | Up to approximately 4 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |