NCT06567314

Phase 2 Study of Ivonescimab in Patients With Cutaneous Squamous Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To learn if ivonescimab can help to control advanced cSCC. The safety and effects of ivonescimab will also be studied.

Detailed description

Primary Objective \- To determine the ORR of ivonescimab in patients with cSCC and CRPC Secondary Objectives * To evaluate other indicators of the antitumor efficacy of ivonescimab in patients with cSCC and CRPC. * To evaluate the safety and tolerability of ivonescimab in patients with cSCC and CRPC Exploratory Objective * To evaluate potential predictors of response and resistance to ivonescimab * To bank pre-treatment blood samples for future correlative analyses * To evaluate imaging characteristics predictive of treatment response and side effects

Conditions

• Cutaneous Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Ivonescimab	Given by PO

Timeline

• Start date: 2024-12-02
• Primary completion: 2028-09-01
• Completion: 2030-09-01
• First posted: 2024-08-22
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study