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

NCT06741644 Phase 1/Phase 2 RECRUITING

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.

Details

Lead sponsor	CStone Pharmaceuticals
Phase	Phase 1/Phase 2
Status	RECRUITING
Enrolment	660
Start date	2025-02-24
Completion	2028-01

Conditions

• Advanced Solid Tumors

Interventions

• CS2009
• CS2009
• Pemetrexed
• Carboplatin
• Paclitaxel
• Etoposide
• Nab-paclitaxel
• Oxaliplatin
• Capecitabine
• Docetaxel

Primary outcomes

• [Dose Escalation] Maximum tolerated dose (MTD) of CS2009 — Cycle 1 (Up to 21 Days)
  Participants will receive CS2009 via intravenous (IV) infusion on Day 1 of repeated 21-day cycles (Q3W). The MTD will be determined, if any, by the number of participants who experience a dose limiting toxicity (DLT).
• [Dose Escalation] Tentative recommended Phase II dose (RP2D) of CS2009 — Cycle 1 (Up to 21 Days)
  The selection of tentative RP2D will be based on consideration of overall safety information together with available pharmacokinetic, pharmacodynamic, and efficacy data. The tentative RP2D may be the MTD or a lower dose within the tolerable dose range.
• [Dose Escalation] Number of participants with adverse events (AEs) — Up to approximately 2 years
• [Dose Expansion] Objective response rate (ORR) evaluated by investigators per RECIST v1.1 — Up to approximately 2 years

Countries

Australia, China