This study will evaluate the preliminary efficacy of the 2 combinations (Sym021+Sym022 and Sym021+Sym023) in each tumor type under study by assessing ORRs per Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. This study will also evaluate the safety and tolerability profile of the 2 combinations (Sym021+Sym022 and Sym021+Sym023)
The study will evaluate safety and efficacy in participant with small cell lung cancer,
urothelial cancer and bladder cancer who have developed resistance to prior anti-PD1 or
anti-PD-L1 therapy and in patient with cholangiocarcinoma who have received at least 1 line
of standard of care therapy and have progressed on it
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | October 12, 2020 | Phase 1 | Interventional |
Primary Outcome 1 - Measure: To evaluate the preliminary efficacy of the 2 combinations (Sym021+Sym022 and Sym021+Sym023) in each tumor type under study by assessing ORRs per Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Primary Outcome 1 - Time Frame: Until disease progression or end of study, whichever comes first, assessed up to 24 months
Primary Outcome 2 - Measure: To evaluate the incidence, severity, and relationship of (S)AEs collected from administration of the first dose of study drug until 30 days after the last dose of the 2 combinations (Sym021+Sym022 and Sym021+Sym023)
Primary Outcome 2 - Time Frame: Through study completion up to 30 days after last dose of the two combinations
Primary Outcome 3 - Measure: To evaluate the AEs leading to dose interruption, dose delays, and permanent treatment stop of the 2 combinations (Sym021+Sym022 and Sym021+Sym023)
Primary Outcome 3 - Time Frame: Through study completion up to a maximum of 12 months
Criteria:
Inclusion Criteria:
Patients must meet all the following criteria to be eligible for participation in the
study:
- Male or female patients, ≥18 years.
- Patients with documented (histologically or cytologically proven) unresectable,
locally advanced, or metastatic malignancies:
1. Urothelial cancer (UC)
2. Small cell lung cancer (SCLC)
3. Endometrial cancer (EC) of any histological subtype
4. Cholangiocarcinoma (CCA): unresectable or metastatic adenocarcinoma of the intra-
and/or extra-hepatic bile ducts
- Patients with UC, SCLC, and EC must have received prior anti-PD-(L)1 therapy with a
best response of CR/PR or durable SD
- Patients with measurable disease according to RECIST v1.1
- Patients with an ECOG PS of 0 or 1, and anticipated life expectancy of ≥3 months
- Patients must have adequate organ function as indicated by laboratory values
- Adequate contraception required as appropriate
Exclusion Criteria:
- Has central nervous system (CNS) malignancies
- Patients with significant cardiovascular disease
- Patients with
1. Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism,
within 4 weeks prior to the first study drug dose
2. Active uncontrolled bleeding or a known bleeding diathesis
- Patients with a significant pulmonary disease or condition
- Patients with a current or recent (within 6 months) significant gastrointestinal
disease or condition
- Patients with a significant ocular disease or condition
- Patients with an active, known or suspected autoimmune disease
- Patients with any other serious/active/uncontrolled infection
- Prior therapy with anti-LAG-3 or anti-TIM-3 or combinations of these 2 antibodies with
anti-PD-(L)1 antibody or with any other systemic or localized therapy
- Patients with a history of significant toxicities associated with previous
administration of immune checkpoint inhibitors that necessitated permanent
discontinuation of that therapy
- Patients with a known or suspected hypersensitivity to any of the excipients of
formulated study drug
- Patients with unresolved >Grade 1 toxicity associated with any prior antineoplastic
therapy
Show More
Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Nehal Lakhani, MD
Role: Principal Investigator
Affiliation: START Midwest
Name: Helle Rudbaek, RN
Phone: +45 88382625
Email: heru@symphogen.com
Facility | Status | Contact |
---|---|---|
Mayo Clinic - Scottsdale/Phoenix Scottsdale, Arizona 85259 United States |
Not yet recruiting |
Daniel Ahn, MD |
University of Colorado Aurora, Colorado 80045 United States |
Not yet recruiting |
Lindsey Davis, MD |
Moffitt Cancer Center Tampa, Florida 33612 United States |
Not yet recruiting |
Richard Kim, MD Richard.kim@moffitt.org |
University of Chicago Chicago, Illinois 60637-1470 United States |
Not yet recruiting |
Chih-Yi "Andy" Liao, MD 773-702-6241 andyliao@medicine.bsd.uchicago.edu |
University of Kansas Medical Center (KUMC) Westwood, Kansas 66205 United States |
Not yet recruiting |
Weijing Sun, MD wsun2@kumc.edu |
START Midwest Grand Rapids, Michigan 49546 United States |
Recruiting |
Nehal Lakhani, MD 616-954-5554 nehal.lakhani@startmidwest.com |
Amita - Mahipal Rochester, Minnesota 55902 United States |
Not yet recruiting |
Amita Mahipal, MD mahipal.amit@mayo.edu |
Montefiore Medical Center PRIME Bronx, New York 10461 United States |
Recruiting |
Sanjay Goel, MD 718-405-8404 sgoel@montefiore.org |
NYU Langone Health New York, New York 10016 United States |
Not yet recruiting |
Daniel Cho, MD Daniel.Cho@nyulangone.org |
Mount Sinai - PRIME New York, New York 10029 United States |
Not yet recruiting |
Thomas Marron, MD 212-824-9472 thomas.marron@mountsinai.org |
University of Cincinnati Medical Center Cincinnati, Ohio 45267 United States |
Not yet recruiting |
Shuchi Gulati, MD gulatisi@ucmail.uc.edu |
MD Anderson Houston, Texas 77230 United States |
Not yet recruiting |
Jordi Rodon, MD 713-792-5603 jrodon@mdanderson.org |
Virginia Cancer Specialists, PC Fairfax, Virginia 22031 United States |
Not yet recruiting |
Alexander Spira, MD alexander.spira@usoncology.com |
Northwest Medical Specialties, PLLC Tacoma, Washington 98405 United States |
Recruiting |
Jorges Chaves, MD 253-428-8700 chaves_research@nwmsonline.com |
Princess Margaret Cancer Centre Toronto, Ontario M5G 1X5 Canada |
Not yet recruiting |
Albiruni Razak, MD 416-586-5371 Albiruni.Razak@uhn.ca |
CHU de Bordeaux Hôpital St André Bordeaux, 33075 France |
Not yet recruiting |
Alain Ravaud, MD alain.ravaud@chu-bordeaux.fr |
Centre Georges-François Leclerc, Department of Medical Oncology Dijon, 21000 France |
Not yet recruiting |
Francois Ghiringhelli, MD |
Institut de Cancerologie de L'Ouest Saint-Herblain, 44805 France |
Not yet recruiting |
Judith Raimbourg, MD judith.raimbourg@ico.unicancer.fr |
Institut Claudius Regaud, IUCT-O Toulouse, 31100 France |
Not yet recruiting |
Jean P Delord, MD |
Charité Berlin, 10117 Germany |
Not yet recruiting |
Sebastian Ochsenreiter, MD |
Universitaetsklinikum Carl Gustav Carus TU Dresden Dresden, 01307 Germany |
Not yet recruiting |
Martin Wermke, MD +49 (0)351 458-7566 martin.wermke@uniklinikum-dresden.de |
Universitaetsklinikum Freiburg Freiburg, 79106 Germany |
Not yet recruiting |
Anna-Lena Illert, MD |
Universitaetsklinikum Hamburg-Eppendorf Hamburg, 20246 Germany |
Not yet recruiting |
Gunhild von Amsberg, MD +4940741050662 g.von-amsberg@uke.de |
Istituto Nazionale Tumori Fondazione G. Pascale Milan, 20133 Italy |
Not yet recruiting |
Silvia Damian, MD |
Istituto Clinico Humanitas Rozzano, 20089 Italy |
Not yet recruiting |
Matteo Simonelli, MD matteo.simonelli@hunimed.eu |
Vall d'Hebron Institute of Oncology Barcelona, 08035 Spain |
Not yet recruiting |
Elena Garralda, MD |
Hospital Universitario San Carlos Madrid, 28040 Spain |
Not yet recruiting |
Aranzazu Manzano, MD |
Centro Integral Oncologico Clara Campal Madrid, 28050 Spain |
Not yet recruiting |
Irene Moreno, MD |