GLPG0187

Giocondo Lorenzon, MSc

The purpose of the study is to determine the safety and tolerability of GLPG0187 administered through continuous intravenous infusion and to explore its preliminary clinical efficacy in patients with solid tumors.

Patients with pathologically confirmed diagnosis of advanced, recurrent, or metastatic cancer and who are refractory to standard therapy or for whom no standard therapy exists will first receive a one-hour infusion of a defined dose of GLPG0187. If well tolerated, one week later a three-week continuous infusion is started. If according to the investigator a subject has a clinical benefit from treatment with GLPG0187, the treatment cycle may be repeated until disease progression, Dose Limiting Toxicity (DLT), or the patient chooses to stop or cannot/will not comply with study procedures.

Throughout treatment, safety and tolerability will be monitored. Within one patient, a fixed dose (infusion rate) will be used. If at a given dose-level sufficient patients have been treated without reaching DLT, the dose for the next group of patients will be increased. This can be repeated until DLT is established, or the scheduled maximum dosage is reached.

GLPG0187: Safety, Tolerability and Pharmacokinetics in Patients With Solid Tumors

An Open-label, Dose Escalating Phase Ib Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Intravenous Doses of GLPG0187 in Subjects With Solid Tumors

Patients will be monitored for cardiovascular safety (ECG) and adverse events, and blood- and urine-samples taken before and at fixed timepoints after a one-hour infusion of GLPG0187; if patients tolerate the treatment well, procedures will be repeated before and at fixed timepoints after the start of a three-week continuous infusion patients. Through monitoring and analysis of the blood- and urine-samples, it will be established whether the study medication would have any negative effects on the patient's general condition. Results will indicate whether DLT has occurred.

Blood samples will be taken at regular timepoints before and on fixed timepoints after start of the one-hour infusion, as well as before and on fixed timepoints during the (first) three-week infusion, to establish the concentration of the study medication in the blood.

Blood samples will be taken at regular timepoints before and on fixed timepoints after start of the one-hour infusion, as well as before and on fixed timepoints during the (first) three-week infusion, to measure the levels of CTx (collagen telopeptide, a bone resorption biomarker).

evaluation of antitumor effects according to RECIST 1.1.

Galapagos NV

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Mitogens

Multiple IV doses of TB-403, an antibody directed against PlGF

TB-403

Ulrik Lassen, MD, PhD

Lena Winstedt, PhD

Dorthe Nielsen, MD, PhD

TB-403 is a monoclonal antibody directed against Placental Growth Factor (PlGF). The antibody binds to PlGF and inhibits the binding to it's receptor, VEGF-1. By preventing this binding, growth of tumor vessels are inhibited and tumor growth prevented.

In this study we are investigating the tolerability and safety of TB-403 in patients with solid tumors who receives multiple intravenous doses of TB-403.

Phase I Study on Monoclonal Antibody TB-403 Directed Against PlGF in Patients With Solid Tumours

An Open, Phase I, Dose Escalation Study of the Monoclonal Antibody TB-403 Directed Against PlGF, Given as Multiple IV-doses to Patients With Solid Tumors.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
GLPG0187: Safety, Tolerability and Pharmacokinetics in Patients With Solid Tumors	NCT01313598	Solid Tumors	GLPG0187	18 Years -	Galapagos NV
GLPG0187: Safety, Tolerability and Pharmacokinetics in Patients With Solid Tumors	NCT01313598	Solid Tumors	GLPG0187	18 Years -	Galapagos NV
Phase I Study on Monoclonal Antibody TB-403 Directed Against PlGF in Patients With Solid Tumours	NCT00702494	Solid Tumors	TB-403	18 Years -	BioInvent International AB

Spots Global Cancer Trial Database for patients with solid tumors