UCLA L-11: A Phase II Trial of Ivonescimab for Previously Treated Thymic Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Biological, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female ≥ 18 years of age and willing and able to provide informed consent

• Cytologically or histologically confirmed thymic carcinoma, which is incurable

• Received prior systemic therapy for thymic carcinoma, or is ineligible for or refuses other therapies

• Measurable disease, as per RECIST 1.1

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

• Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L

• Platelets ≥ 100 × 10\^9/L

• Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L

• Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (CrCl) ≥ 50 mL/min (glomerular filtration rate \[GFR\] can also be used in place of creatinine or CrCl)

‣ Estimated glomerular filtration rate (eGFR) value ≥ 50 mL/min for participants with creatinine levels \> 1.5 x institutional ULN

⁃ Creatinine clearance may be calculated using the Cockcroft-Gault formula or estimated glomerular filtration rate (eGFR) may be calculated using the Modification of Diet in Renal Disease (MDRD) GFR equation

• Urine dipstick protein ˂ 2+ OR 24 hour urine protein quantification ˂ 1.0 g

• Serum total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN

• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 2.5 x ULN OR ≤ 5 x ULN for participants with liver metastases

• Albumin ≥ 2.5 g/dL

• International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy, and then only as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants

• Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy, and then only as long as PT or PTT is within therapeutic range of intended use of anticoagulants

• Female participants of childbearing potential must have a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the participant to be eligible. Female participants must agree to use a highly effective method of contraception from the beginning of screening until 120 days after the last dose of the ivonescimab, or be of non-childbearing potential. Non-childbearing potential is defined as follows (by other than medical reasons):

‣ ≥ 45 years of age and has not had menses for \> 2 years,

⁃ Participants who have been amenorrhoeic for \< 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation, or

⁃ Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation

• Unsterilized male patients having sex with a female partner of childbearing potential, or a pregnant or breastfeeding partner must agree to use barrier contraception (male condom) for the duration of the treatment period until 120 days after the last dose of ivonescimab. Male patients with female partners of childbearing potential must have the female partner agree to use at least 1 form of highly effective contraception for the duration of the treatment period until 120 days after the last dose of ivonescimab

• Male and female participants must agree not to donate sperm or eggs, respectively, from the first study-drug treatment through 120 days after the last study drug treatment

• Female participants must agree to not breastfeed during the study or for 120 days after the last dose of study treatment

Locations
United States
California
UCLA / Jonsson Comprehensive Cancer Center
RECRUITING
Los Angeles
Contact Information
Primary
Lia R. Ethridge
letheridge@mednet.ucla.edu
424-387-1086
Time Frame
Start Date: 2025-07-15
Estimated Completion Date: 2028-06-17
Participants
Target number of participants: 25
Treatments
Experimental: Treatment (ivonescimab)
Patients receive ivonescimab IV over 60-120 minutes on day 1 of each cycle. Cycles repeat Q3W for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and collection of blood and urine samples throughout the study. Patients may undergo MRI throughout the study if indicated and may optionally undergo a biopsy at the end of treatment.
Related Therapeutic Areas
Sponsors
Leads: Jonsson Comprehensive Cancer Center
Collaborators: Summit Therapeutics

This content was sourced from clinicaltrials.gov

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