A Phase Ⅰ Study of CS08399 in Participants With MTAP-deleted Solid Tumors and Lymphoma (NCT07583771) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase Ⅰ Study of CS08399 in Participants With MTAP-deleted Solid Tumors and Lymphoma
China186 participantsStarted 2026-06
Plain-language summary
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).
Who can participate
Age range
18 Years
Sex
ALL
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Inclusion criteria
. Understand and sign the informed consent form voluntarily.
. ≥18 years old when signing the informed consent, regardless of sex.
. Histologically or cytologically confirmed locally advanced or metastatic solid tumors, or relapsed/refractory lymphoma, for which standard therapy has failed or is not tolerated, and no further standard therapy is available. Homozygous MTAP or CDKN2A deletion confirmed by tissue or peripheral blood testing.
. For glioblastoma: at least one measurable intracranial tumor lesion according to the RANO 2.0 criteria. For other solid tumors: at least one measurable lesion according to RECIST v1.1 criteria. For lymphoma: at least one measurable lesion according to Lugano 2014 criteria.
. For glioblastoma: KPS score ≥60. For other solid tumors and lymphoma: ECOG performance status of 0 or 1.
What they're measuring
1
incidence of dose-limiting toxicity (DLT)
Timeframe: 34 days after, that is 6 days after single-dose and 28 days after first administration in multiple-dose
2
maximum tolerated dose (MTD)
Timeframe: dose escalation part, up to approximately 2 year
3
incidence of adverse events (AEs)
Timeframe: from first administration to 28 days after last administration or next anti-tumor therapy, whichever occurs first
4
Pharmacokinetic parameters: Time to Maximum Concentration (Tmax)
Timeframe: during treatment, up to approximately 2 year
5
Pharmacokinetic parameters: Maximum Concentration (Cmax)
Timeframe: during treatment, up to approximately 2 year
6
Pharmacokinetic parameters: Area Under the Concentration-time Curve(AUC)
Timeframe: during treatment, up to approximately 2 year
. Able to swallow and retain oral study medication.
Exclusion criteria
. Received any anti-tumor therapy (including but not limited to chemotherapy, targeted therapy, anti angiogenic therapy, immunotherapy, cell therapy, radiotherapy, tumor embolization, etc.) or experimental drugs/devices that have not been approved for marketing within 28 days prior to the first dose or are still within 5 half-lives of such drugs (whichever is shorter).
. Previously received MAT2A or PRMT5 inhibitors.
. Underwent major surgery (cranial, thoracic, or abdominal) within 28 days prior to the first dose or have unresolved wounds, ulcers, or fractures.
. Have unresolved toxicities from previous treatments that have not recovered to CTCAE v5.0 grade ≤1.
. History of other primary malignancies within 5 years prior to the first dose.
. For solid tumors : The presence of active, clinically symptomatic central nervous system metastases or leptomeningeal metastases or spinal cord compression at screening.
. Primary central nervous system lymphoma or systemic lymphoma with CNS involvement.
. Evidence of interstitial lung disease, pulmonary fibrosis, or non-infectious pneumonitis requiring treatment on chest imaging at screening.
Timeframe: during treatment, up to approximately 2 years
8
Pharmacokinetic parameters: Accumulation Ratio (Rac)
Timeframe: during treatment, up to approximately 2 years