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Brief Title: Sym021 in Combination With Either Sym022 or Sym023 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

INTRODUCTION

  • Org Study ID: Sym021-02
  • Secondary ID: N/A
  • NCT ID: NCT04641871
  • Sponsor: 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


  • Overall Status
    Recruiting
  • Start Date
    October 12, 2020
  • Phase
    Phase 1
  • Study Type
    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 - Timeframe: 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 - Timeframe: 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 - Timeframe: Through study completion up to a maximum of 12 months

CONDITION

  • Metastatic Cancer
  • Solid Tumor

ELIGIBILITY


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

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Nehal Lakhani, MD

Role: Principal Investigator

Affiliation: START Midwest

Overall Contact

Name: Nehal Lakhani, MD

Phone: +45 88382625

Email: heru@symphogen.com

LOCATION

Facility Status Contact
Facility: START Midwest
Grand Rapids, Michigan 49546
United States 		Status: Recruiting Contact: Nehal Lakhani, MD
616-954-5554
nehal.lakhani@startmidwest.com
Facility: Montefiore Medical Center PRIME
Bronx, New York 10461
United States 		Status: Recruiting Contact: Sanjay Goel, MD
718-405-8404
sgoel@montefiore.org
Facility: Northwest Medical Specialties, PLLC
Tacoma, Washington 98405
United States 		Status: Recruiting Contact: Jorges Chaves, MD
253-428-8700
chaves_research@nwmsonline.com

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