Actively Recruiting
Ivonescimab for the Treatment of Thymic Cancer
Led by Jonsson Comprehensive Cancer Center · Updated on 2025-10-20
25
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
J
Jonsson Comprehensive Cancer Center
Lead Sponsor
S
Summit Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests how well ivonescimab works in treating patients with thymic carcinoma. Immunotherapy with monoclonal antibodies, such as ivonescimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
CONDITIONS
Official Title
Ivonescimab for the Treatment of Thymic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older and able to provide informed consent
- Cytologically or histologically confirmed incurable thymic carcinoma
- Received prior systemic therapy for thymic carcinoma, or ineligible for or refusing other therapies
- Measurable disease per RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Absolute neutrophil count (ANC) of at least 1.5 x 10^9/L
- Platelet count of at least 100 x 10^9/L
- Hemoglobin level of at least 9 g/dL or 5.6 mmol/L
- Serum creatinine less than or equal to 1.5 times upper limit of normal (ULN) or creatinine clearance of at least 50 mL/min
- Urine protein dipstick less than or equal to 2+ or 24-hour urine protein less than or equal to 1.0 g
- Serum total bilirubin less than or equal to 1.5 times ULN or direct bilirubin within normal limits
- AST and ALT less than or equal to 2.5 times ULN or up to 5 times ULN if liver metastases are present
- Albumin level of at least 2.5 g/dL
- INR or prothrombin time (PT) less than or equal to 1.5 times ULN unless on anticoagulants with therapeutic range
- Activated partial thromboplastin time (aPTT) less than or equal to 1.5 times ULN unless on anticoagulants with therapeutic range
- Female participants of childbearing potential must have a negative pregnancy test and agree to use effective contraception during screening through 120 days after last dose
- Male participants with female partners of childbearing potential must agree to use barrier contraception during treatment through 120 days after last dose
- Male and female participants must agree not to donate sperm or eggs from first treatment through 120 days after last dose
- Female participants must agree not to breastfeed during the study and for 120 days after last dose
You will not qualify if you...
- Prior treatment with immune checkpoint inhibitors targeting PD-1 or PD-L1
- Concurrent enrollment in another clinical study except follow-up or observational studies
- Recent chemotherapy, immunotherapy, biologic, or hormonal therapy within 3 weeks or 5 half-lives
- Thoracic radiation of 30 Gy or more within 3 months; other radiation within 3 weeks except allowed types
- Use of investigational anticancer therapy within 21 days prior to first dose
- Unresolved toxicities from previous therapy greater than grade 1 except certain allowed conditions
- Known allergy or sensitivity to study treatment components
- Active autoimmune conditions requiring systemic immune suppression
- Positive paraneoplastic serologies including acetylcholine receptor antibodies
- Recent major surgery or serious trauma within 4 weeks
- Poorly controlled hypertension or significant cardiac conditions
- Recent myocardial infarction or thrombosis within 6 months
- Tumor features posing bleeding or fistula risk
- Active or uncontrolled infections requiring intravenous antibiotics
- Pregnancy or breastfeeding or plans to conceive during study and up to 210 days after last dose
- Progressive or symptomatic brain metastases; certain brain metastases are allowed
- Recent history of other cancers within 2 years except certain treated types
- History of bleeding disorders or significant bleeding risk
- Unstable use of anticoagulants or anti-platelet agents
- Recent gastrointestinal perforation, fistula, obstruction, or extensive bowel surgery
- Active or recent autoimmune or lung diseases requiring systemic therapy within 2 years
- Pre-existing peripheral neuropathy grade 2 or higher
- Uncontrolled pleural, pericardial effusions, or ascites
- History of non-infectious pneumonia requiring steroids or interstitial lung disease
- Active or prior inflammatory bowel disease
- Uncontrolled HIV or viral infections
- Current use of systemic corticosteroids over 10 mg prednisone or equivalent
- History of organ or stem cell transplantation
- Recent live vaccine administration
- Serious uncontrolled medical disorders or psychiatric conditions interfering with study participation
- Unable or unwilling to comply with study protocol
- Any condition interfering with treatment evaluation or safety assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
K
Kim Nahyun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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