Exploratory Study of BO-112 in Adult Patients With Aggressive Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02828098|
Recruitment Status : Terminated
First Posted : July 11, 2016
Last Update Posted : July 31, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: Part 1: BO-112 Drug: Part 2: BO-112||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Exploratory First in Human Phase I Clinical and Pharmacokinetic Study of Intra-tumoral Administration of BO-112 in Adult Patients With Aggressive Solid Tumors, With an Extension Cohort in Combination With Anti-PD1 Treatment|
|Study Start Date :||June 2016|
|Actual Primary Completion Date :||July 2020|
|Actual Study Completion Date :||July 2020|
Experimental: Part 1: BO-112 IT
BO-112 dose 1 (starting dose) intratumoral injection. BO-112 dose 2, 3 and 4 are expected to be tested, upon confirmation of the safety profile of the starting dose.
Drug: Part 1: BO-112
Cohorts of three patients per dose level will be treated consecutively in the absence of Dose Limiting Toxicity (DLT).
Experimental: Part 2: BO-112 IT
Combination treatment of BO-112 intratumoral injections with standard of care nivolumab intravenous treatment
Or Combination treatment of BO-112 intratumoral injections with standard of care pembrolizumab intravenous treatment
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.
Other Name: anti-PD1 monoclonal antibody
- Number of subjects with adverse events [ Time Frame: Part 1: Day 30 after administration of the last dose. Part 2: 12 weeks and for patients who continue up to 1 year ]To evaluate the safety and tolerability of B0-112 in terms of adverse events at every visit
- Circulating cytokines including type I IFNs, TNFalpha and IL6 (by ELISA) [ Time Frame: Part 1: At three independent points during the study. Day 7-1 prior to administration, 24 hours after administration and 7-14 days after administration of the agent. Part 2: 12 weeks ]
- Plasma levels of BO-112 [ Time Frame: Part 1: 0-15-30-240 minutes and 24 hours after administration of the drug. Part 2: 1 day ]To characterize the pharmacokinetics (PK) of BO-112 by measuring the amount in plasma at regular timepoints during the study
- Anti-tumor activity [ Time Frame: 12 weeks and for patients who continue up to 1 year ]Part 2 only: To evaluate the antitumor activity of the combination of BO-112 and anti-PD1 treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02828098
|Clínica Universitaria Navarra|
|Pamplona, Navarra, Spain, 31008|
|ICO Hospital Duran i Reynals|
|Barcelona, Spain, 08908|
|Hospital General Universitario Gregorio Marañón|
|Madrid, Spain, 28007|
|Hospital Universitario Ramon y Cajal|
|Madrid, Spain, 28034|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Hospital Universitario Quiron Madrid|
|Madrid, Spain, 28223|
|Hospital Universitario Virgen de la Victoria|
|Malaga, Spain, 29010|