Exploratory Study of BO-112 in Adult Patients With Aggressive Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

July 31, 2020

Study Completion Date

July 31, 2020

Conditions
Cancer
Interventions
DRUG

Part 1: BO-112

Cohorts of three patients per dose level will be treated consecutively in the absence of Dose Limiting Toxicity (DLT).

DRUG

Part 2: BO-112

"BO-112 at a fixed dose will be administered as an intratumoral injection for up to 5 doses over 12 weeks and continue as long as there is benefit.~Nivolumab will be administered as an intravenous infusion every 2 weeks at a dose of 3 mg/kg for up to a total period of one year.~OR Pembrolizumab will be administered as an intravenous infusion every 3 weeks at either 200 mg or at 2 mg/kg depending on the indication, for up to a total period of one year."

Trial Locations (7)

28007

Hospital General Universitario Gregorio Marañón, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28223

Hospital Universitario Quiron Madrid, Madrid

29010

Hospital Universitario Virgen de la Victoria, Málaga

31008

Clínica Universitaria Navarra, Pamplona

08908

ICO Hospital Duran i Reynals, Barcelona

Sponsors
All Listed Sponsors
collaborator

Pivotal S.L.

INDUSTRY

lead

Highlight Therapeutics

INDUSTRY