NCT06741644

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

A Phase I/II, Dose-Escalation and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CS2009, a Tri-specific Antibody Targeting PD-1/VEGFA/CTLA-4, as Monotherapy and Combination Therapy in Participants With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 660 (estimated)
• Sponsor: CStone Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	CS2009	CS2009 will be administered via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W).
DRUG	CS2009	CS2009 will be administered via intravenous (IV) infusion on Day 1 of repeated 14/21-day cycles (Q2W/Q3W).
DRUG	Pemetrexed	IV infusion
DRUG	Carboplatin	IV infusion
DRUG	Paclitaxel	IV infusion
DRUG	Etoposide	IV infusion
DRUG	Nab-paclitaxel	IV infusion
DRUG	Oxaliplatin	IV infusion
DRUG	Capecitabine	oral tablets
DRUG	Docetaxel	IV infusion
DRUG	Leucovorin	IV infusion
DRUG	5-FU	IV infusion
DRUG	Cisplatin	IV infusion

Timeline

• Start date: 2025-02-24
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2024-12-19
• Last updated: 2026-04-15

Locations

31 sites across 2 countries: Australia, China

Regulatory

• FDA-regulated drug study