Phase 2 Study of Ivonescimab in Patients With Cutaneous Squamous Cell Carcinoma and Castration-resistant Prostate Cancer
M.D. Anderson Cancer Center
Summary
To learn if ivonescimab can help to control advanced cSCC. The safety and effects of ivonescimab will also be studied.
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Ability to understand and willingness to sign informed consent form prior to initiation of the study and any study procedures. * Age ≥18 years. * Has locally advanced surgically non-appropriate (unresectable and/or metastatic) cSCC (Cohort 1).. * Has metastatic CRPC (Cohort 2): * Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology. * Documented prostate cancer progression as documented by PSA progression according to PCWG3 criteria. * Surgically or medically castrated, with serum t…
Interventions
- DrugIvonescimab
Given by PO
Location
- MD Anderson Cancer CenterHouston, Texas