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

NCT07583771 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2026-05-13

No results posted yet for this study

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).

Conditions

Interventions

DRUG

CS08399

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.

Sponsors & Collaborators

  • Chipscreen Biosciences, Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2029-08-31
Completion
2030-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07583771 on ClinicalTrials.gov