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

NCT06567314 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2024-0501NCI-2024-07130
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cutaneous Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year.

Study Arms (1)

Ivonescimab

EXPERIMENTAL

Participants found to be eligible to take part in this study, you will receive ivonescimab by vein over about 1-2 hours on Day 1 of each 21-day cycle (1 time every 3 weeks).

Drug: Ivonescimab

Interventions

Ivonescimab DRUG

Given by PO

Ivonescimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix 1).
• Cohort 1: measurable disease per the RECIST v1.1 or Measurable by mRECIST for skin cancer or Global Assessment or Papillary/Ulceration Response Assessment or Pathological Assessment or WHO Criteria for Response Assessment in Cutaneous Squamous Cell Carcinoma, as appropriate (Appendix 4).
• Adequate organ and marrow function as defined below within 28 days of study treatment initiation:
• Hemoglobin \>9.0 g/dL
• Absolute neutrophil count ≥1500/mL
• Platelets ≥100,000/mL
• Total bilirubin ≤1.5 institutional upper limit of normal (ULN). Documented Gilbert syndrome is allowed if total bilirubin is ≤3 × ULN.

You may not qualify if:

• 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.
• Unresolved toxicities from prior therapy (defined as having not resolved to NCI CTCAE v.5.0 Grade ≤1 or baseline) or any other toxicity that is deemed irreversible by the investigator. Exceptions include endocrinopathies from prior therapy or disease and successfully treated (such as hypothyroidism, diabetes mellitus), alopecia, vitiligo, and Grade ≤2 peripheral neuropathy.
• Major blood vessel invasion.
• Major surgical procedures or serious trauma within 4 weeks prior to study treatment initiation, or plans for major surgical procedures within 4 weeks after the first dose of study treatment (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to study treatment initiation.
• Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \[NYHA\] classification Grade ≥2) or vascular disease (e.g., aortic aneurysm at risk of rupture) that required hospitalization within 12 months prior to study treatment initiation, or other cardiac impairment that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial ischemia).
• History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to study treatment initiation.
• History of arterial thromboembolic event, venous thromboembolic event of Grade ≥3 as specified in NCI CTCAE v5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to study treatment initiation.
• Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks prior to study treatment initiation.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Summit Therapeutics: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

Study Officials

• Aung Naing, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aung Naing, MD

CONTACT

(713) 563-3885; anaing@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 22, 2024
• Study Start: December 2, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (1)