CancerPhase 1NCT02828098
Exploratory Study of BO-112 in Adult Patients With Aggressive Solid Tumors
A Phase 1 study testing Part 1: BO-112 and Part 2: BO-112 in people with Cancer, run by Highlight Therapeutics at 7 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Part 1: BO-112 and Part 2: BO-112
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 7 sitesSpain
- Study dates
- Jun 2016to Jul 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age 18 years or more on the day of signing informed consent form.
- Histologically or cytologically confirmed aggressive solid tumors
- Patients must have:
- Biopsy-accessible tumors
- No prior anticancer treatment during the last 14 days
- Additional inclusion criteria for Part 2: disease progression on treatment with anti-PD1 antibody for an approved indication
Who cannot join
- Other relevant and clinically significant concomitant diseases or adverse clinical conditions which may jeopardize patient safety:
- Increased cardiac risk: congestive heart failure; or unstable angina pectoris; or arrhythmia requiring treatment or uncontrolled arterial hypertension; or myocardial infarction within 12 months before inclusion in the study.
- Patients with active central nervous system (CNS) lesions (including carcinomatous meningitis) will be excluded. However, patients will be eligible if:
- All known CNS lesions have been treated with stereotactic therapy or surgery, AND
- There has been no evidence of clinical and radiographic disease progression in the CNS for ≥ 4 weeks after radiotherapy or surgery, and has not required to increase in the last 4 weeks their steroids use or has not started a new course of steroids
- Whole brain radiotherapy is not allowed, with the exception of patients who have had definitive resection or stereotactic therapy of all radiologically detectable parenchymal brain lesions.
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- Active infection.
- Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis B or C).
- Any clinically significant abnormality on history or examination including diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication (physiologic doses of corticosteroids may be approved after consultation with the Sponsor).
- Additional exclusion criteria for Part 2: Grade 3-4 toxicity due to anti-PD1 antibody or permanent discontinuation of anti-PD1 antibody due to immune related or other adverse reaction.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
ICO Hospital Duran i Reynals
Barcelona, 08908
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Ramon y Cajal
Madrid, 28034
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Quiron Madrid
Madrid, 28223
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Clínica Universitaria Navarra
Pamplona, Navarre, 31008
About this study
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
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.
Read more
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
- Conditions
- Cancer
- Being tested
- Part 1: BO-112, Part 2: BO-112
- Keywords
- aggressive solid tumors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part 1: BO-112Drug
Cohorts of three patients per dose level will be treated consecutively in the absence of Dose Limiting Toxicity (DLT).
Part 2: BO-112Drug
Also called anti-PD1 monoclonal antibody
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.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: BO-112 IT | Experimental | 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. Receives: Drug: Part 1: BO-112 |
| Part 2: BO-112 IT | Experimental | 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 Receives: Drug: Part 2: BO-112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events
To evaluate the safety and tolerability of B0-112 in terms of adverse events at every visit
Measured: Part 1: Day 30 after administration of the last dose. Part 2: 12 weeks and for patients who continue up to 1 year
Secondary outcomes (3)
Circulating cytokines including type I IFNs, TNFalpha and IL6 (by ELISA)
Measured: 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
To characterize the pharmacokinetics (PK) of BO-112 by measuring the amount in plasma at regular timepoints during the study
Measured: Part 1: 0-15-30-240 minutes and 24 hours after administration of the drug. Part 2: 1 day
Anti-tumor activity
Part 2 only: To evaluate the antitumor activity of the combination of BO-112 and anti-PD1 treatment
Measured: 12 weeks and for patients who continue up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionJul 2020
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Highlight Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pivotal S.L.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828098
- Sponsor's protocol ID
- 112/2016-IT
- Status last verified
- Jan 2024
- First submitted
- 23 Jun 2016
- Last updated
- 29 Jan 2024
- Results posted
- No
Publications
Aznar MA, Planelles L, Perez-Olivares M, Molina C, Garasa S, Etxeberria I, Perez G, Rodriguez I, Bolanos E, Lopez-Casas P, Rodriguez-Ruiz ME, Perez-Gracia JL, Marquez-Rodas I, Teijeira A, Quintero M, Melero I. Immunotherapeutic effects of intratumoral nanoplexed poly I:C. J Immunother Cancer. 2019 May 2;7(1):116. doi: 10.1186/s40425-019-0568-2.
PubMed 31046839
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02828098
- Acronym / sponsor ID
- 112/2016-IT
- Conditions
- Cancer
- Keywords
- aggressive solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Highlight TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Pivotal S.L.
- Study start
- Jun 2016
- Primary completion
- Jul 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: BO-112 IT | Experimental | Drug: Part 1: BO-112BO-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. |
| Part 2: BO-112 IT | Experimental | Drug: Part 2: BO-112Combination 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients age 18 years or more on the day of signing informed consent form.
- Histologically or cytologically confirmed aggressive solid tumors
- Patients must have:
- Additional inclusion criteria for Part 2: disease progression on treatment with anti-PD1 antibody for an approved indication
Key exclusion criteria (10 listed)
- Other relevant and clinically significant concomitant diseases or adverse clinical conditions which may jeopardize patient safety:
- Increased cardiac risk: congestive heart failure; or unstable angina pectoris; or arrhythmia requiring treatment or uncontrolled arterial hypertension; or myocardial infarction within 12 months before inclusion in the study.
- Patients with active central nervous system (CNS) lesions (including carcinomatous meningitis) will be excluded. However, patients will be eligible if:
- Active infection.
- Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis B or C).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Part 1: BO-112Cohorts of three patients per dose level will be treated consecutively in the absence of Dose Limiting Toxicity (DLT). | Drug | Part 1: BO-112 IT |
| Part 2: BO-112Also: anti-PD1 monoclonal antibodyBO-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. | Drug | Part 2: BO-112 IT |
Primary outcome
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
3 secondary outcomes
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
Anti-tumor activity
Time frame: 12 weeks and for patients who continue up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Derived from this study: PubMed 31046839Aznar MA, Planelles L, Perez-Olivares M, Molina C, Garasa S, Etxeberria I, Perez G, Rodriguez I, Bolanos E, Lopez-Casas P, Rodriguez-Ruiz ME, Perez-Gracia JL, Marquez-Rodas I, Teijeira A, Quintero M, Melero I. Immunotherapeutic effects of intratumoral nanoplexed poly I:C. J Immunother Cancer. 2019 May 2;7(1):116. doi: 10.1186/s40425-019-0568-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Part 1: BO-112 and Part 2: BO-112 in people with Cancer, run by Highlight Therapeutics at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02828098, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.