PD-1/TIGIT bispecific mAb

The key inclusion criteria are –

• HER2 (IHC 3+/2+) and pMMR by central testing
• Primary advanced (Stage III/IV) or first recurrent EC
• Measurable disease per RECIST 1.1 criteria
• Adequate FFPE tumor tissue sample of a tumor lesion that was not previously irradiated for central HER2, MMR, and PD-L1 IHC testing and valid central test results
• Naïve to 1L systemic therapy. May have received prior radiation therapy for EC (washout period required)
• Allowed 1 L of adjuvant/neoadjuvant chemo (+/- chemoradiation) if recurrence ≥6 months after last chemo; prior adjuvant/neoadjuvant trastuzumab allowed
• No prior exposure to ADCs or immune checkpoint inhibitors including (but not limited to) anti-PD-1/PD-L1/PD-L2 and anti-CTLA-4 antibodies and therapeutic anticancer vaccines
• ECOG Performance Status 0-1
• Adequate organ/bone marrow function
• LVEF ≥ 50% within 28 days before randomization

Reference:

Study NCT06989112. ClinicalTrials.gov website. 

The key exclusion criteria are –

• History of organ transplant
• Active or uncontrolled illness (infection, GI conditions)
• Spinal cord compression or CNS metastases
• History or current ILD/pneumonitis
• Lung diseases (pulmonary emboli <3 months of enrollment, severe asthma, COPD, restrictive lung disease, pleural effusion, complete pneumonectomy)
• Active or documented autoimmune or inflammatory disorders requiring immunosuppressive or steroids treatment
• Active primary immunodeficiency/active infections (uncontrolled TB, HIV, or HBV/HCV)
• Concurrent anticancer treatment without washout period
• Cardiovascular diseases (history of MI <6 months before randomization, symptomatic CHF, arrhythmia or cardiomyopathy)