Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Symphogen A/S
Study ID
NCT04641871
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Cancer
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sym021 — DRUG
    IV infusion over 30 minutes on day 1 and 15 of each cycle.
  • Sym022 — DRUG
    IV infusion over 30 minutes on day 1 and 15 of each cycle.
  • Sym023 — DRUG
    IV infusion over 30 minutes on day 1 and 15 of each cycle.
  • Irinotecan Hydrochloride — DRUG
    IV infusion over 90 min on day 1 and 15 of the first 2 cycles. After 2 cycles of treatment, irinotecan may be discontinued at the Investigator's discretion

Study Details

The study will evaluate the preliminary efficacy of 3 combinations (Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irinotecan) in patients with biliary tract carcinomas (BTC) and with esophageal squamous cell carcinoma (ESCC) by assessing overall response rates (ORRs) per Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 The study will also evaluate the safety and tolerability profile of the 3 combinations

Key Dates

Start date
Oct 12, 2020
Status verified
Jun 2024
Primary completion
Jun 3, 2024
Completion
Jun 3, 2024

Study Design

Enrollment
78 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sym021+Sym022 [ARM A] for BTC patients
    Sym021 will be infused over approximately 30 minutes (+10 minutes), followed by a 30-minute post-dosing interval before infusion of Sym022 over approximately 30 minutes (+10 minutes). The duration of each infusion may be extended by 30 minutes, or longer, if indicated.
  • Experimental: Sym021+Sym023 [ARM B] for BTC patients
    Sym021 will be infused over approximately 30 minutes (+10 minutes), followed by a 30-minute post-dosing interval before infusion of Sym023 over approximately 30 minutes (+10 minutes). The duration of each infusion may be extended by 30 minutes, or longer, if indicated.
  • Experimental: Sym021+Sym023+irrinotecan for BTC patients
    Sym021 will be infused over approximately 30 minutes (+10 minutes), followed by a 30-minute post-dosing interval before infusion of Sym023 over approximately 30 minutes (+10 minutes). The duration of each infusion may be extended by 30 minutes, or longer, if indicated. After another 30-minute post-dosing interval, irinotecan will be infused over 90 minutes.
  • Experimental: Sym021+Sym023+irrinotecan for ESCC patients
    Sym021 will be infused over approximately 30 minutes (+10 minutes), followed by a 30-minute post-dosing interval before infusion of Sym023 over approximately 30 minutes (+10 minutes). The duration of each infusion may be extended by 30 minutes, or longer, if indicated. After another 30-minute post-dosing interval, irinotecan will be infused over 90 minutes.

Primary Outcome Measure

To evaluate the preliminary efficacy of the combinations Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irinotecan in patients with BTC or ESCC by assessing overall response rates (ORRs) per Investigator assessment using RECISTv.1.1 [ Time Frame: Until disease progression or end of study, whichever comes first, assessed up to 24 months ]

Locations (12)

FacilityCityStateZIPSite coordinators
University of ColoradoAuroraColorado80045-
Mayo Clinic - JacksonvilleJacksonvilleFlorida32224-
Moffitt Cancer CenterTampaFlorida33612-
University of ChicagoChicagoIllinois60637-1470-
University of Kansas Medical Center (KUMC)WestwoodKansas66205-
START MidwestGrand RapidsMichigan49546-
Mayo ClinicRochesterMinnesota55902-
Mount Sinai - PRIMENew YorkNew York10029-
Montefiore Medical Center PRIMEThe BronxNew York10461-
University of Cincinnati Medical CenterCincinnatiOhio45267-
MD AndersonHoustonTexas77230-
Virginia Cancer Specialists, PCFairfaxVirginia22031-

Find similar trials in Aurora, CO

By research site
University of Colorado· Aurora, COMayo Clinic - Jacksonville· Jacksonville, FLMoffitt Cancer Center· Tampa, FLUniversity of Chicago· Chicago, ILUniversity of Kansas Medical Center (KUMC)· Westwood, KSSTART Midwest· Grand Rapids, MI

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