Phase Ia/Ib, open-label, multicenter, dose-escalation study followed by an extension phase to evaluate the safety, pharmacokinetics and activity of RO5479599, a glycoengineered antibody against HER3, administered either alone (Part A) or in combination with cetuximab (Part B) or in combination with erlotinib (Part C) in patients with metastatic and/or locally advanced malignant HER3-positive solid tumors of epithelial cell;origin.

Completed

• Conditions: gevorderde en/of gemetastaseerde solide tumoren; solid tumors; cancer

• Registration Number: NL-OMON41335
• Lead Sponsor: Roche Nederland B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 97

Inclusion Criteria

• Adult patients, >/= 18 years of age;• European Cooperative Oncology Group (ECOG) performance status 0-2;• Histologically confirmed metastatic and/or locally advanced malignant HER3-expressing solid tumors of epithelian origin;• Availability of tissue and willingness to perform fresh pretreatment biopsies;• Patients for whom no standard therapy exists;• Life expectancy of >= 12 weeks. ;• All acute toxic effects of any prior radiotherapy, chemotherapy or surgical procedure must have resolved to Grade </= 1, except for alopecia and Grade 2 peripheral neuropathy;• Adequate hematological, renal and liver function;• Patient's with Gilbert's syndrome will be eligible for the study;• Part A extension cohort: : In addition to the above inclusion criteria, patients will be eligible if they have metastatic and/or locally advanced malignant HER3-expressing solid tumors of epithelial cell origin;• Part B extension cohort: In addition to the above inclusion criteria, patients will be eligible if they have metastatic and/or locally advanced non-small cell lung cancer or squamous cell carcinoma of the head and neck or colorectal cancer (CRC must be EGFR pos. and KRAS wt).;• Part C extension cohort: In addition to the above inclusion criteria, patients will be eligible if they have metastatic and/or locally advanced squamous non-small cell lung cancer or non-squamous carcinomas with documented NRG1 somatic gene fusion

Exclusion Criteria

• Known or clinically suspected CNS primary tumors or metastases including leptomeningeal metastases, except for previously treated CNS metastases that are asymptomatic and did not require steroids or enzyme-inducing anticonvulsants in the last 14 days;• Evidence of significant uncontrolled concomitant diseases or disorders;• Active or uncontrolled infections;• HIV infection;• Major surgery or significant traumatic injury < 28 days prior to the 1st RO5479599 infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment.;• Therapy with antibody or immunotherapy concurrently or within 14 days prior to first dose of study drug;• Regular immunosuppressive therapy;• Concurrent high dose of systemic corticosteroids (> 20 mg/day dexamethasone or equivalent for > 7 consecutive days);• Baseline QTc interval of > 470 ms, patients with baseline resting bradycardia < 45 beats per minute, or baseline resting tachycardia > 100 beats per minute.

Study & Design

• Study Type: Interventional
• Study Design: Not specified