RecruitingCutaneous Squamous Cell Carcinoma

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

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

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

Sponsor: M.D. Anderson Cancer Center

✓ 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 testosterone level \<50 ng/dL.
✓ Refractory or naïve to anti-PD-1 therapy (Cohort 1). There is no limit on the number of prior lines of therapy. NOTE: Detailed information regarding duration of prior anti-PD-1 therapy and the extent of progression at the time of anti-PD-1 therapy discontinuation will be collected.

✕ Patients who have previously been treated with PD-1/PD-L1 inhibitors and required permanent discontinuation, or systemic immunosuppression due to irAEs.
✕ History of allergic reactions attributed to compounds of similar chemical or biologic composition to ivonescimab.
✕ Pregnant or breastfeeding.
✕ Participants with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
✕ Known history of positive test for human immunodeficiency virus or known acquired immunodeficiency syndrome.
✕ Known history of acute or chronic hepatitis B virus or hepatitis C virus infection.
✕ Previous solid organ or allogeneic hematopoietic stem cell transplant.
✕ Active infection requiring IV antibiotics or other uncontrolled intercurrent illness requiring hospitalization.

Houston

Source: ClinicalTrials.gov · NCT06567314 · last updated 2026-06-11