Sym004 Versus Futuximab or Modotuximab in Patients With mCRC

Stopped early · Phase 2

Conditions studied: Metastatic Colorectal Cancer, Colorectal Cancer Metastatic, Carcinoma

In brief

This is a Phase 2, randomized, open-label, 3-arm trial in the ratio of 1:1:1 to either Sym004 (Arm A) versus each of its component monoclonal antibodies (mAbs), futuximab (Arm B) or modotuximab (Arm C), in genomically-selected patients with chemotherapy-refractory metastatic colorectal carcinoma (mCRC) and acquired resistance to anti-epidermal growth factor receptor (anti-EGFR) mAb therapy. The study is designed to evaluate the relative antitumor activity of each agent as assessed by imaging studies performed after 8 weeks of treatment.

Key facts

Study ID: NCT03549338
Run by: Symphogen A/S
People needed: 2
Starts: 2018-11-29
Expected to finish: 2019-03-09
Last updated by the study team: 2020-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female patients, ≥ 18 years of age at the time of obtaining informed consent.
Histologically- or cytologically-confirmed mCRC.
Microsatellite instability-high (MSI-H) / mismatch repair-deficient (dMMR) tumors must have received prior therapy with pembrolizumab, nivolumab, or other programmed cell death protein-1 (PD-1)/programmed death-ligand 1 (PD-L1) pathway blocker, and must have progressed on that therapy.
Meeting the protocol definition of TNmCRC assessed in the screening blood test.
mCRC currently not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumor.
Measurable disease according to RECIST v1.1, and willingness to undergo a total of 2 biopsies of a primary or metastatic tumor site(s) considered safely accessible for biopsy.
Must have received at least 2 prior regimens of standard chemotherapy for mCRC and must have been refractory to or failed (includes intolerance to) those regimens. Prior standard chemotherapy may not have included TAS-102 or regorafenib, but must have included agents as specified in the protocol.
"Acquired" resistance to commercially available anti-EGFR mAbs approved for the treatment of mCRC must have:
Received treatment with an anti-EGFR for ≥16 weeks
Progressive disease (PD) documented by imaging or clinical findings less than or equal to 6 calendar months after cessation of previous anti-EGFR mAb treatment
No more than 6 calendar months from last dose of previous anti-EGFR mAb treatment to date of consent for this trial (regardless of the line of therapy in which it was used)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
Not of childbearing potential or who agree to use a highly effective method of contraception during the study beginning within 2 weeks prior to the first dose and continuing until 3 months after the last dose of study drug.

You may not qualify if…

Women who are pregnant or lactating or intending to become pregnant before, during, or within 3 months after the last dose of study drug.
Prior history of specific mutations (specified in the protocol) in the tumor at the time of any previous assessment.
Known, untreated central nervous system (CNS) or leptomeningeal metastases, or spinal cord compression; patients with any of these not controlled by prior surgery or radiotherapy, or patients with symptoms suggesting CNS involvement for which treatment is required
An active second malignancy or history of another malignancy within the last 5 years, with exceptions.
Active thrombosis, or a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 4 weeks prior to first administration of study drug unless adequately treated and considered by the Investigator to be stable.
Active uncontrolled bleeding or a known bleeding diathesis
Known clinically significant cardiovascular disease or condition.
Non-healing wounds on any part of the body.
Significant gastrointestinal abnormality.
Skin rash > Grade 1 from prior anti-EGFR therapy at the time of randomization.
Unresolved > Grade 1 toxicity associated with any prior antineoplastic therapy
Drugs and Other Treatments Exclusion Criteria:
Prior treatment with TAS-102 or regorafenib
Any antineoplastic agent for the primary malignancy (standard or investigational) without delayed toxicity within 4 weeks prior to first administration of IMP and during study with exceptions
Any other investigational treatments within 4 weeks prior to and during study; includes participation in any medical device or other therapeutic intervention clinical trials
Radiotherapy as specified in the protocol
Immunosuppressive or systemic hormonal therapy (> 10 mg daily prednisone equivalent) within 2 weeks prior to first administration of IMP and during study; allowed therapies are specified in the protocol.

Where it is running

City of Hope - Comprehensive Cancer Center — Duarte, California, United States
Emory University Hospital — Atlanta, Georgia, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
University of North Carolina - Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
Uniklinik Dresden — Dresden, Germany
Universitaetsklinikum Essen — Essen, Germany
Asklepios Kliniken Altona — Hamburg, Germany
Universitätsmedizin Mannheim — Mannheim, Germany
Städtisches Klinikum München — München, Germany
ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" — Naples, Italy
Università degli Studi della Campania "Luigi Vanvitelli" — Naples, Italy
Hospital del Mar — Barcelona, Spain
Vall d'Hebron Institut d'Oncologia (VHIO) — Barcelona, Spain
Institut Català d'Oncologia — Barcelona, Spain
Hospital Universitario HM Sanchinarro — Madrid, Spain
Hospital Clínico de Valencia — Valencia, Spain

Full record on ClinicalTrials.gov

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