Sym021 in Combination With Either Sym022 or Sym023 in Patients With Advanced Solid Tumor Malignancies

  • Interventional
  • Recruiting
  • NCT04641871
Eligibility Details Visit Clinicaltrials.gov

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

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.

     Per 22nd of December 2020 recruitment for small cell lung cancer, urothelial cancer and bladder cancer has temporarily stopped due to strategy considerations. Recruitment for cholangiocarcinoma is still open.

     Per May 2021 recruitment into the trial is temporarily halted. Symphogen wish to halt recruitment during the first planned interim analysis as the recruitment is faster than expected and therefore many patient could be enrolled before the results of the interim analysis is known. A protocol amendment has been submitted 23rd of April to FDA including changes for the temporarily halt in recruitment during interim analysis.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT04641871

IRB#IRB20-1264

Lead SponsorSymphogen A/S

Lead PhysicianChih-Yi Liao

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting