A Study of SGN-MesoC2 in Advanced Solid Tumors

Launched by SEAGEN, A WHOLLY OWNED SUBSIDIARY OF PFIZER · Jun 17, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called SGN-MesoC2 for people with advanced solid tumors, which are types of cancer that start in organs like the lungs, pancreas, or ovaries. The study is specifically for patients whose cancer has either come back after treatment or didn’t respond to standard therapies. To participate, you need to have a type of cancer that cannot be treated with existing drugs and have a measurable tumor that can be evaluated. Some of the cancers included are non-small cell lung cancer, ovarian cancer, pancreatic cancer, and colorectal cancer.

Participants in this study will be given SGN-MesoC2, which is designed to target and kill cancer cells. The trial has three parts: the first two parts will help determine the right dose of the drug, and the third part will test its safety and effectiveness. If you qualify and choose to join the trial, you’ll be monitored closely by medical professionals throughout the process to ensure your safety. It's important to note that there are specific health criteria you must meet to be eligible, so discussing this option with your doctor can help you understand if this trial is right for you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 18 years or older.
• • Histologically- or cytologically-confirmed metastatic or locally advanced unresectable platinum-resistant ovarian cancer, NSCLC, pancreatic ductal adenocarcinoma, endometrial cancer, colorectal cancer, or mesothelioma, who have relapsed or progressed following standard therapies, or for which no standard therapies are available.
• • An Eastern Cooperative Oncology Group performance status score of 0 or 1.
• • At least 1 measurable lesion at baseline based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
• • Archival tumor tissue or a fresh tumor biopsy during the screening period.
• • Adequate hepatic, renal and bone marrow function.
• • Participants must not have received more than 2 lines of cytotoxic systemic therapy in the metastatic setting (Parts B and C only).
• Exclusion Criteria:
• • Previously received or currently receiving any systemic anticancer therapy or focal radiotherapy within 4 weeks prior to the first dose of MesoC2 or within 2 weeks prior to the first dose of MesoC2 if the underlying disease had progressed on treatment.
• • Prior anti-MSLN antibody or MSLN-directed ADC (Part C only).
• • Unresolved toxicities from prior therapy greater than NCI CTCAE v5.0 grade 1 at the time of study treatment (except alopecia).
• • Inadequate hepatic dysfunction, renal function, or hematologic abnormalities.
• • Previously untreated brain metastases. Participants who received radiation or surgery for brain metastases are eligible if therapy was completed at least 4 weeks prior to study treatment initiation, and there was no evidence of central nervous system progression nor requirements for chronic corticosteroid therapy