A Phase Ⅰ Study of CS08399 in Participants With MTAP-deleted Solid Tumors and Lymphoma

Sponsor
Chipscreen Biosciences, Ltd.
Study ID
NCT07583771
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

First listed
May 13, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Aug 31, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
186 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CS08399
    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.

Primary Outcome Measure

incidence of dose-limiting toxicity (DLT) [ Time Frame: 34 days after, that is 6 days after single-dose and 28 days after first administration in multiple-dose ]

Central Contacts

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