drugset / Trial / NCT06741644

A Phase I/II Study of CS2009 in Participants With Advanced Solid Tumors

NCT06741644

Phase 1/2 Recruiting 660 enrolled CStone Pharmaceuticals
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a first-in-human (FIH), open-label, and multi-center Phase I/II study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS2009 as Monotherapy and Combination Therapy in Participants with Advanced Solid Tumors. The study is comprised of a Phase I dose escalation and Phase II dose expansion.

Timeline

Start
2025-02-24
Primary completion
2027-01
Completion
2028-01

Drugs

EvaluationDrugModalityDoseRoute
Subject CS2009 Unknown Intravenous
Background Capecitabine Small molecule Oral
Background Carboplatin Small molecule Intravenous
Background Cisplatin Other / unclassified Intravenous
Background Docetaxel Small molecule Intravenous
Background Etoposide Small molecule Intravenous
Background Leucovorin Small molecule Intravenous
Background Oxaliplatin Small molecule Intravenous
Background Paclitaxel Small molecule Intravenous
Background Pemetrexed Small molecule Intravenous
Background fluorouracil Small molecule Intravenous

Indications