Exploratory Study of BO-112 in Adult Patients With Aggressive Solid Tumors
Status:
Terminated
Trial end date:
2020-07-01
Target enrollment:
Participant gender:
Summary
Part 1: 16 to 32 patients with aggressive solid tumors from whom biopsies can be obtained,
will receive BO-112 through IT administration.
Injected lesions must be palpable and biopsiable at the time of injection, and biopsied after
7-14 days. Patients will not receive an alternative therapy during the period comprising from
first and second biopsy. BO-112 will be administered at a starting dose. Upon confirmation of
the safety profile of the starting dose and evaluation of the pharmacokinetic (PK) profile,
three additional dose levels are expected to be tested.
During the course of the study, subjects will be examined for any side effects that may occur
(safety and tolerability).
Additionally this study will also study BO-112 biological activity, the innate and adaptive
immune system response and signaling pathways, as well as signs of clinical relevance, will
be studied.
Part 2: An additional 30 patients with progressive disease while on anti-PD1 treatment for an
approved indication, will receive BO-112 through IT administration in combination with the
anti-PD1 treatment to evaluate the safety and tolerability of the combination.
Injected lesions must be palpable and biopsiable at the time of injection. Patients will
continue with their anti-PD1 treatment. During the course of the study, patients will be
examined for any side effects that may occur (safety and tolerability).
Additionally this part of the trial will also study BO-112 biological activity, the innate
and adaptive immune system response and signaling pathways, as well as signs of clinical
response