Sym015 (Anti-MET) in Patients with Advanced Solid Tumor Malignancies

Phase 1

• Conditions: Advanced Solid Tumor Malignancies; MedDRA version: 21.1Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-003912-11-DK
• Lead Sponsor: Symphogen A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-21
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 57

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) solid tumor malignancy that is locally advanced or metastatic, and that is refractory to standard therapy or for which no standard therapy is available (i.e. patients must have recurrent and/or progressive disease and be without other therapeutic options)

Additional main inclusion criteria applicable to Part 2 ONLY:
• Measurable disease according to RECIST v1.1 that has been confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) within 4 weeks prior to Cycle 1/Day 1 (C1/D1)

Basket Cohort ONLY:
• Tumor documented to be KRAS WT by local assessment according to institutional standards.
• Confirmed MET-amplification
• No prior therapy with MET-targeting agents

NSLC MET-Amplified Cohort ONLY:
• Documented NSCLC meeting disease criteria as defined above
• Documented MET-amplification by either:
- Local assessment in a recent tumor biopsy
- Central confirmation in a newly performed pre-dosing tumor biopsy
• may have received prior therapy with MET-targeting and/or EGFR-targeting agents (antibodies or TKIs)

NSCLC METEx14Del Cohort ONLY:
• Documented NSCLC meeting disease criteria as defined above
• Documented METEx14Del (tumors need not be MET-amplified)
• May have received prior therapy with MET-targeting and/or EGFR-targeting agents (antibodies or TKIs)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Main exclusion criteria all patients, Part 1 and Part 2:
• 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
• Immunosuppressive or systemic hormonal therapy (> 10 mg daily prednisone equivalent) within 2 weeks prior to C1/D1 (for exceptions,
see Protocol Section 7.5.2)
• 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 specified allowed exceptions
• Central nervous system (CNS) malignancy including primary malignancies of the CNS, 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 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
• Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 1 month prior to C1/D1, unless adequately treated and stable
• Active uncontrolled bleeding or a known bleeding diathesis
• Significant cardiovascular disease or condition
• Abnormal hematologic, renal or hepatic function
• Any of the following within 2 weeks prior to C1/D1:
o Any serious or uncontrolled infection
o Any infection requiring parenteral antibiotics
o Unexplained fever >38.0 °C

Part 2 – Basket Cohort ONLY :
• Prior therapy with MET-inhibiting agents
• Prior therapy with antibody to HGF

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified