Investigating SGN-MesoC2 for advanced solid tumors
A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of SGN-MesoC2 in Subjects With Advanced Solid Tumors
This study is testing a new drug called SGN-MesoC2 to see if it can help people with advanced solid tumors that haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 365 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Seagen Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 19 sites (Birmingham, Alabama and 18 other locations) |
| Trial ID | NCT06466187 on ClinicalTrials.gov |
What this trial studies
This clinical trial is focused on patients with advanced solid tumors that are either metastatic or locally advanced and cannot be treated with standard therapies. It evaluates the efficacy of an experimental drug called PF-08052666/SGN-MesoC2, which is an antibody-drug conjugate designed to target and kill cancer cells. The trial consists of three parts, assessing the drug's safety and effectiveness in patients who have relapsed or progressed after standard treatments. Participants must have measurable lesions and meet specific health criteria to be eligible.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with specific types of advanced solid tumors that are platinum-resistant and have not responded to standard therapies.
Not a fit: Patients with tumors that can be treated with standard care or those who have received more than two lines of cytotoxic systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat advanced solid tumors.
How similar studies have performed: Other studies using antibody-drug conjugates have shown promising results, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 18 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- The University of Kansas Clinical Research Center — Fairway, Kansas, United States (Recruiting)
- The University of Kansas Hospital Cambridge North Tower A — Kansas City, Kansas, United States (Recruiting)
- The University of Kansas Hospital — Kansas City, Kansas, United States (Recruiting)
- The University of Kansas Medical Center Medical Office Building — Kansas City, Kansas, United States (Recruiting)
- The University of Kansas Cancer Center - Indian Creek Campus — Overland Park, Kansas, United States (Recruiting)
- The University of Kansas Cancer Center - Westwood — Westwood, Kansas, United States (Recruiting)
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (Recruiting)
- James Cancer Hospital and Solove Research Institute — Columbus, Ohio, United States (Recruiting)
- Ohio State University Hospital — Columbus, Ohio, United States (Recruiting)
- OSU Brain and Spine Hospital — Columbus, Ohio, United States (Recruiting)
- Martha Morehouse Tower — Columbus, Ohio, United States (Recruiting)
- Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run — Hilliard, Ohio, United States (Recruiting)
- SCRI Oncology Partners — Nashville, Tennessee, United States (Recruiting)
- South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States (Recruiting)
- START Mountain Region — West Valley City, Utah, United States (Recruiting)
- University Health Network, Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Not_yet_recruiting)
- McGill University Health Centre — Montreal, Quebec, Canada (Not_yet_recruiting)
Study contacts
- Study coordinator: Seagen Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.