Sym013 (Pan-HER) in Patients With Advanced Epithelial Malignancies

• Status: Terminated
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is the first study to test Sym013 (Pan-HER) in humans. The primary purpose of this study is to see if Sym013 is safe and effective for patients with advanced epithelial malignancies without available therapeutic options.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Symphogen A/S

Criteria

Inclusion Criteria:

Main inclusion criteria all patients, Part 1 and Part 2:

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

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

• Life expectancy >3 months assessed during Screening

• Documented (histologically- or cytologically-proven) epithelial malignancy that is locally advanced or metastatic, having received all therapy known to confer clinical benefit

Additional inclusion criteria applicable to Part 2 ONLY:

• Epithelial malignancy (tumor types to be determined), measurable according to RECIST v1.1 that has been confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) within 4 weeks prior to C1/D1

• Willingness to undergo a pre-and post-dosing biopsy (total of 2 biopsies) from primary or metastatic tumor site(s) considered safe for biopsy

Exclusion Criteria:

• Any antineoplastic agent for the primary malignancy (standard or investigational) without delayed toxicity within 4 weeks or 5 plasma half-lives (whichever is shortest) prior to C1/D1, except nitrosoureas and mitomycin C within 6 weeks prior to C1/D1.

• Part 2 ONLY: Radiotherapy against target lesions within 4 weeks prior to C1/D1, unless there is documented progression of the lesion following radiotherapy

• Immunosuppressive or systemic hormonal therapy (>10 mg daily prednisone equivalent) within 2 weeks prior to C1/D1 with exceptions

• Use of hematopoietic growth factors within 2 weeks prior to C1/D1

• Active second malignancy or history of another malignancy within the last 3 years, with allowed exceptions

• Central nervous system (CNS) malignancies including:

1. Primary malignancies of the CNS

2. Known, untreated CNS or leptomeningeal metastases, or spinal cord compression; patients with any of these not controlled by prior surgery or radiotherapy, or symptoms suggesting CNS metastatic involvement for which treatment is required

• Inadequate recovery from an acute toxicity associated with any prior antineoplastic therapy

• Major surgical procedure within 4 weeks prior to C1/D1 or inadequate recovery from any prior surgical procedure

• Non-healing wounds on any part of the body

• Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks prior to C1/D1, unless adequately treated and stable

• Active uncontrolled bleeding or a known bleeding diathesis

• Significant gastrointestinal abnormalities

• Significant cardiovascular disease or condition

• Abnormal hematologic, renal or hepatic function