A Study of RO5458640 in Patients With Advanced Solid Tumors

A Phase I Multiple Ascending Dose (MAD) Study of RO5458640, a Humanized Monoclonal Antibody Against the TNF-like Weak Inducer of Apoptosis (TWEAK) Ligand, in Patients With Advanced Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01383733

Enrollment

Registered

2011-06-28

Start date

2011-07-31

Completion date

2013-03-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

Brief summary

This multicenter, open-label, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of RO5458640 in patients with advanced solid tumors. Cohorts of patients will receive ascending doses of RO5458640 intravenously, either weekly or every 2 weeks or every 3 weeks, until disease progression or unacceptable toxicity occurs.

Interventions

DRUGRO5458640

Multiple ascending doses intravenously, weekly or every 2 weeks or every 3 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients, \>/= 18 years of age * Histologically or cytologically confirmed malignant solid tumors * Measurable and/or evaluable disease according to RECIST 1.1 criteria * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Adequate bone marrow, liver and renal function

Exclusion criteria

* Prior chemotherapy, radiotherapy, or hormonal therapy for cancer within 3 weeks of first study treatment, except for short course palliative radiotherapy for pain * Antibody therapy or other immunotherapy currently or less than 21 days prior to study treatment * Current immunosuppressive therapy, including those prescribed for organ transplantation and rheumatologic disease * Corticoid therapy \> 10 mg/day prednisone or equivalent * Patients who have not recovered from \> grade 1 (NCI CTCAE) prior adverse events from any cancer therapy, except for alopecia * Pregnant or breastfeeding women * Known hypersensitivity to any component of RO5458640 or previous severe hypersensitivity reactions to monoclonal antibody therapy * History of active seizure disorder * History of CNS or leptomeningeal metastases, except for clinically stable disease for at least 3 weeks prior to first study drug * Cardiovascular illness: CVA or MI \< 6 months prior to study, CHF \> NYHA Class 2, QTcF \>480 msec. * Active infection

Design outcomes

Primary

Measure	Time frame
Safety: Incidence of adverse events	approximately 2 years
Dose Limiting Toxicity (DLT) according to CTEP Common Terminology Criteria for Adverse Events Version 4.0	approximately 2 years
Maximum Tolerated Dose (MTD)	approximately 2 years

Secondary

Measure	Time frame
Pharmacokinetics: area under the concentration - time curve (AUC) on two administration schedules	approximately 2 years
Tumor response according to RECIST criteria	approximately 2 years
Antigenicity: Human anti-human antibody [HAHA] profile	approximately 2 years

Countries

Canada, Denmark, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026