Phase I Clinical Study Combining L19-IL2 With SABR in Patients With Oligometastatic Solid Tumor

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

May 31, 2017

Study Completion Date

May 31, 2017

Conditions
Solid Tumour
Interventions
DRUG

L19-IL2

"Patients receive a schedule of 1 x 30 Gy, 3 x 15-20 Gy; 5 x 12 Gy; 8 x 7.5 Gy; to the 80 % or 100 % isodose.~Step -1: Toxicity of 10 Mio IU of L19-IL2 (n=3-6)10 Mio IU of L19-IL2 (max. 6 cycles) via i.v. bolus injection.~Toxicity scored at every i.v. drug administration and on day 7, 14 and 21. Step 1: Toxicity of 15 Mio IU of L19-IL2 (n=3-6)(max. 6 cycles) via i.v. bolus injection.~Step 2: Toxicity of 22.5 Mio IU of L19-IL2 (n=3-6)(max. 6 cycles) via i.v. bolus injection.~Toxicity scored at every i.v. drug administration and on day 7, 14 and 21 of the cycle.~Step 3: Expansion cohort of the maximally tolerable dose (n=10) Administration of the maximally tolerable dose of L19-IL2(max. 6 cycles) via i.v. bolus injection.~Toxicity scored at every i.v. drug administration and on day 7, 14 and 21 of the cycle."

Trial Locations (1)

6229 ET

MAASTRO clinic, Maastricht

All Listed Sponsors
lead

Maastricht Radiation Oncology

OTHER

NCT02086721 - Phase I Clinical Study Combining L19-IL2 With SABR in Patients With Oligometastatic Solid Tumor | Biotech Hunter | Biotech Hunter