April 14th 2015 Dear Colleagues, Please find below details
April 14th 2015 Dear Colleagues, Please find below details of a clinical study just opened to patient accrual at Northwestern Medicine Developmental Therapeutics Institute (NMDTI). An open-label, Phase I, dose-escalation trial to evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and pharmacodynamics of the anti-FGFR2 antibody drug conjugate BAY 1187982 in subjects with advanced solid tumors known to express FGFR2 FGF aberrancy is observed in several different malignancies. FGFR2 is overexpressed on cancer cells and plays a role in metastasis and chemoresistance. BAY 1187982 is an antibody-drug conjugate (ADC) consisting of an anti-FGFR2 antibody and a stably linked, highly potent and non-cell permeable toxophore specifically targeting FGFR2 on the cancer cell surface. The released toxophore drug then causes cancer cell death. Preclinical studies demonstrated that targeting FGFR could lead to antitumor effects. Please click on this Eligibility Criteria link to see more patient-specific information. If you would like more information on this or any other NMDTI study, please click on any name below to generate a contact email or reply directly to this message. Aparna Kalyan, MD 312-926-4291 [email protected] Benedito Carneiro, MD 312-926-3892 [email protected] Jason Kaplan, MD 312-926-4295 [email protected] Cesar Santa-Maria, MD 312-695-2381 [email protected] Young Kwang Chae, MD 312-926-4248 [email protected] Sarika Jain, MD 312-695-0268 [email protected] Al Benson, MD 312-695-6180 [email protected] Sunandana Chandra, MD 312-926-4299 [email protected] Mary Mulcahy, MD 312-695-4440 [email protected] Sheetal Kircher, MD 312-695-6180 [email protected] Schema FGF / FGFR signaling system: 4 FGFRs & 22 FGFs Study Objectives This study will evaluate the safety, tolerability and maximum tolerated dose of the anti-FGFR2 antibody drug conjugate BAY 1187982 in advanced solid malignancies known to express FGFR2. Pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, biomarkers, and tumor response profile of BAY 118798 will be explored. Study Design/Schema Phase I, first-in-human (FIH), open-label, non-randomized, multi-center, dose escalation / dose expansion trial of BAY 1187982 in sequential cohorts of subjects with advanced solid tumors known to express FGFR2. Patient Population Patient population eligible for this trial will be those with advanced malignancies known to express FGFR2, which are refractory to standard therapy or have no standard therapy. The study consists of two phases: (1) Dose escalation phase where the trial population will be limited to solid tumor types with a described expression of FGFR2. (2) Dose expansion phase the enrollment will be restricted to subjects with confirmed FGFR2 expression on their tumor. Patients will undergo serial assessments for antitumor efficacy and drug safety. Blood sampling for PK, PD and immunogenicity analyses will be conducted in all patients treated with BAY 1187982. Tumor scans will be evaluated locally for patient treatment decisions. For more information about this study, or any other NMDTI study, please contact us at [email protected]. To learn more about NMDTI, please visit: www.nmdti.org
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