Clinical Trials /

Sym004 in Combination With FOLFIRI in Metastatic Colorectal Cancer Patients

NCT02568046

Description:

This is a Phase 1b/2a study investigating the safety and efficacy of Sym004, an investigational medicinal product (IMP), in combination with FOLFIRI (chemotherapy) when administered every second week (Q2W).

Related Conditions:
  • Colorectal Carcinoma
Recruiting Status:

Terminated

Phase:

Phase 1/Phase 2

URL:

https://clinicaltrials.gov/show/NCT02568046

Trial Eligibility

Document

Title

  • Brief Title: Sym004 in Combination With FOLFIRI in Metastatic Colorectal Cancer Patients
  • Official Title: An Open Label, Multi-Center Phase 1b/2a Trial Investigating Different Doses of Sym004 in Combination With FOLFIRI in Patients With Metastatic Colorectal Cancer Progressing After First-Line Therapy

Clinical Trial IDs

  • ORG STUDY ID: Sym004-09
  • SECONDARY ID: 2015-003047-19
  • NCT ID: NCT02568046

Conditions

  • Metastatic Colorectal Cancer

Interventions

DrugSynonymsArms
Sym004Sym004 (RP2D) + FOLFIRI
FOLFIRIIrinotecan (Camptosar), Folinic Acid (Leucovorin), Fluorouracil (5-FU)Sym004 (RP2D) + FOLFIRI

Purpose

This is a Phase 1b/2a study investigating the safety and efficacy of Sym004, an investigational medicinal product (IMP), in combination with FOLFIRI (chemotherapy) when administered every second week (Q2W).

Detailed Description

      In the Phase 1b (Dose-Escalation) portion of the trial, patients will be sequentially
      enrolled to dose-escalation cohorts until establishment of the Maximum Tolerated Dose (MTD)
      and/or Recommended Phase 2 Dose (RP2D) of Sym004 in combination with FOLFIRI.

      The Phase 2a (Dose-Expansion) portion of the trial is expected to begin after establishing
      the RP2D.

      Note: In January 2017, the trial was terminated during Phase 1b and enrollment was
      prematurely discontinued. The primary objective changed to assess the safety of the treatment
      combination; collection of data for secondary and exploratory objectives was omitted.

Trial Arms

NameTypeDescriptionInterventions
Sym004 12 mg/kg + FOLFIRIExperimentalPhase 1b, Dose-Escalation: Dose Level 1
  • Sym004
  • FOLFIRI
Sym004 9 mg/kg + FOLFIRIExperimentalPhase 1b, Dose-Escalation: Dose Level -1
  • Sym004
  • FOLFIRI
Sym004 (RP2D) + FOLFIRIExperimentalPhase 2a, Dose-Expansion: Sym004 in the RP2D in combination with FOLFIRI
  • Sym004
  • FOLFIRI

Eligibility Criteria

        Main inclusion Criteria:

          1. Male or female, at least 18 years of age at the time of informed consent

          2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

          3. Histologically or cytologically confirmed, locally advanced or metastatic colorectal
             cancer (CRC) that is documented to be without Kirsten rat sarcoma (KRAS) or
             neuroblastoma rat sarcoma (NRAS) gene mutations (i.e., tumors must express the KRAS
             and NRAS wild type [WT], exon 2, 3 and 4).

          4. Failed (defined as radiologic progression) treatment for locally advanced or
             metastatic disease with first-line combination therapy of oxaliplatin and a
             fluoropyrimidine, with or without bevacizumab, during treatment or < 3 months after
             the last dose of first-line therapy and within < 3 months of C1/D1. Patients who
             discontinued first-line therapy due to toxicity may be enrolled provided progression
             occurred < 6 months after the last dose of the first-line therapy regimen.

             or Failed (defined as radiologic progression) adjuvant therapy with combination
             therapy of oxaliplatin and a fluoropyrimidine during treatment or within < 6 months
             after the last dose of oxaliplatin and within < 6 months of C1/D1.

          5. Eligible for FOLFIRI

          6. Measurable disease according to RECIST v1.1

        Main exclusion Criteria:

          1. Prior therapy with anti-EGFR antibodies, anti-EGFR small molecule inhibitors or
             irinotecan (CPT-11)

          2. Any antineoplastic agent (standard or investigational) within 4 weeks prior to C1/D1

          3. Significant gastrointestinal abnormalities

          4. Patients with a significant cardiovascular disease or condition

          5. Abnormal hematologic, renal or hepatic function
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants With Adverse Events (AEs) by Nature, Severity, and Occurrence Measured From Baseline to End of Trial Participation, as Assessed by the Common Terminology Criteria for AEs (Version 4.03) (CTCAE v4.03).
Time Frame:15 months
Safety Issue:
Description:AEs were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. The incidence and type of AEs (e.g., treatment-emergent AE [TEAE]) were summarized according to MedDRA system organ classes and preferred terms. An AE was considered as treatment-emergent if it occurred after the first treatment administration.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:Symphogen A/S

Trial Keywords

  • Metastatic Colorectal Cancer

Last Updated

March 26, 2019