SUPPORT HOTLINE (888) 901-2226
Donate Now

BRIEF TITLE: Sym021 (Anti-PD-1) in Combination With Either Sym022 (Anti-LAG-3) or Sym023 (Anti-TIM-3) in Patients With Advanced Solid Tumor Malignancies

An Exploratory, Open-label, Multicenter Phase 1b Trial to Evaluate Safety and Efficacy of Sym021 (Anti-PD-1) in Combination With Either Sym022 (Anti-LAG-3) or Sym023 (Anti-TIM-3) in Patients With Advanced Solid Tumor Malignancies


  • Org Study ID: Sym021-02
  • Secondary ID:
  • NCT ID: NCT04641871
  • NCT Alias:
  • Sponsor: Symphogen A/S - Industry
  • Source: Symphogen A/S

Brief Summary

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)

Detailed Description


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 Outcomes:

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

Condition:

  • Metastatic Cancer
  • Solid Tumor

Eligibility

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

Official Information

Name: Nehal Lakhani, MD

Role: Principal Investigator

Affiliation: START Midwest

Overall Contact

Name: Helle Rudbaek, RN

Phone: +45 88382625

Email: heru@symphogen.com

Locations

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