Phase 1/2Recruiting
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
- Sponsor
- CStone Pharmaceuticals (Industry)
- Enrolment
- 800 planned
- Conditions
- Advanced Solid Tumors
- Interventions
- CS2009; CS2009; Pemetrexed; Carboplatin; Paclitaxel; Etoposide; Nab-paclitaxel; Oxaliplatin; Capecitabine; Docetaxel; Leucovorin; 5-FU
- Ages
- adults, older adults
- Registry
- NCT06741644
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- [Dose Escalation] Maximum tolerated dose (MTD) of CS2009
- [Dose Escalation] Tentative recommended Phase II dose (RP2D) of CS2009
- [Dose Escalation] Number of participants with adverse events (AEs)
- [Dose Expansion] Objective response rate (ORR) evaluated by investigators per RECIST v1.1
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered