Table of Contents
- Trials overview
- Conditions and patient groups
- Trial phases and study designs
- Main endpoints and what they mean
- Trial-by-trial summary
- What patients should know from these studies
Trials overview
The available studies of ZELENECTIDE PEVEDOTIN are testing it in different advanced cancers, not as a general medicine description but as a research treatment in clinical trials.[1] The trials are all interventional, which means patients receive a study treatment and researchers measure the results.[1] The studies are authorised and include four trials with different cancer groups, phases, and goals.[1][2][3][4]
Conditions and patient groups
One Phase 2 study is for people with advanced or metastatic non-small cell lung cancer and focuses on tumors with NECTIN4 amplification.[1] Another Phase 4 study is for people with locally advanced or metastatic urothelial cancer, which is cancer of the urinary tract lining.[2] A third Phase 2 study is for people with NECTIN4 amplified advanced breast cancer.[3]
The Phase 1/2 study includes people with Nectin-4 expressing advanced malignancies, meaning advanced cancers that show Nectin-4 on the tumor cells.[4] That study also includes special groups such as patients with moderate to severe renal insufficiency, which means reduced kidney function.[4] Some parts of the urothelial cancer study also include patients who are cisplatin-ineligible, meaning they cannot receive cisplatin-based chemotherapy.[2]
Trial phases and study designs
The lung cancer and breast cancer studies are both Phase 2 trials, which usually look for early signs that a treatment may work in a specific cancer group.[1][3] The urothelial cancer study is a Phase 4 trial with a much larger enrollment, suggesting a broader comparison of treatment approaches in a later research stage.[2] The study in advanced malignancies is a Phase 1/2 trial, which combines early safety and dose work with later effectiveness testing.[4]
The Phase 1/2 study includes several parts: escalation cohorts, expansion cohorts, a renal insufficiency cohort, and a pharmacokinetic cohort.[4] Escalation means the researchers first study treatment levels to learn more about safety and the best dose, while expansion means they then test that treatment in more patients with the same cancer type.[4] The urothelial cancer study compares ZELENECTIDE PEVEDOTIN with other treatment strategies, including pembrolizumab, avelumab, cisplatin, carboplatin, and gemcitabine in different cohorts.[2]
Main endpoints and what they mean
The main endpoint in the lung cancer and breast cancer Phase 2 studies is objective response rate, or ORR, which is the percentage of patients whose tumors have a confirmed complete response or partial response.[1][3] A complete response means no visible tumor is seen on scans, while a partial response means the tumor has shrunk but not disappeared.[1][3] Both studies use RECIST v1.1, which is a standard system for measuring tumor changes.[1][3]
The urothelial cancer study uses different main endpoints in different cohorts.[2] In one cohort, the main endpoint is progression-free survival, or PFS, which measures the time from randomization until the cancer gets worse or the patient dies.[2] In another cohort, the main endpoint is ORR measured by blinded independent central review, which means scan results are checked by independent experts who do not know which treatment was given.[2]
The Phase 1/2 study measures safety, dose-limiting toxicity, ORR, and blood levels of ZELENECTIDE PEVEDOTIN and MMAE.[4] Dose-limiting toxicity means side effects serious enough to limit how much treatment can be given.[4] The study also looks at pharmacokinetics, which means how the body handles the study drug over time.[4]
Trial-by-trial summary
2025-521115-40-00: This Phase 2 study is in advanced or metastatic non-small cell lung cancer with NECTIN4 amplification. The main goal is to measure ORR in 72 participants.[1]
NCT06225596: This Phase 4 study is in locally advanced or metastatic urothelial cancer. It includes 956 participants and measures PFS in one cohort and ORR in another.[2]
NCT06840483: This Phase 2 study is in NECTIN4 amplified advanced breast cancer. It plans to enroll 66 participants and measures ORR.[3]
NCT04561362: This Phase 1/2 study is in Nectin-4 expressing advanced malignancies. It includes 430 participants and measures safety, dose-limiting toxicity, ORR, and drug levels in the blood.[4]
What patients should know from these studies
These trials are focused on adults with advanced cancer, and the study entry rules are based on the type of cancer and whether the tumor shows NECTIN4 or Nectin-4 expression.[1][2][3][4]
The research is trying to find out whether ZELENECTIDE PEVEDOTIN can shrink tumors, delay cancer growth, and be studied safely in different patient groups.[1][2][3][4]
Because the studies use different phases and different comparison groups, they are not all asking the same question.[1][2][3][4] Some are mainly about early safety and dose finding, while others are mainly about how well the treatment works in a specific cancer.[4][1][2][3]
