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
aparna.kalyan@northwestern.edu
Benedito Carneiro, MD
312-926-3892
benedito.carneiro@northwestern.edu
Jason Kaplan, MD
312-926-4295
jason.kaplan@northwestern.edu
Cesar Santa-Maria, MD
312-695-2381
cesar.santamaria@northwestern.edu
Young Kwang Chae, MD
312-926-4248
young.chae@northwestern.edu
Sarika Jain, MD
312-695-0268
Sarika.jain@northwestern.edu
Al Benson, MD
312-695-6180
a-benson@northwestern.edu
Sunandana Chandra, MD
312-926-4299
Sunandana.chandra@northwestern.edu
Mary Mulcahy, MD
312-695-4440
m-mulcahy@northwestern.edu
Sheetal Kircher, MD
312-695-6180
s-kircher@northwestern.edu
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
nmdti@northwestern.edu. To learn more about NMDTI, please visit: www.nmdti.org