Cancer - Solid TumoursPhase 1NCT04025307
Phase I Trial of bacTRL-IL-12 in Adult Subjects With Advanced, Treatment-refractory Solid Tumours
A Phase 1 study testing bacTRL-IL-12 in people with Cancer - Solid Tumours, run by IQVIA Pty Ltd at 1 site in Australia.
Trial summary
This study is as an open-label study to be conducted at multiple study centres across New Zealand and Australia designed to characterise the safety, tolerability and preliminary assessment of the anti-tumour efficacy of bacTRL-IL-12 after intravenous (IV) infusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer - Solid Tumours
- What is being tested?
- bacTRL-IL-12
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Aug 2019to 29 Dec 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
- Adults (18 years or older);
- Capable of providing informed consent;
- Advanced and/or metastatic, histologically-documented, measurable (per iRECIST) solid tumours for which there are no other standard therapy options available that are acceptable to the subject;
- Eastern Cooperative Oncology Group status of 0 or 1;
- Adequate haematological status (regardless of transfusions) defined as:
- Absolute neutrophil count ≥ 1.5 x 109/L;
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- Platelets ≥ 100 x 109/L;
- Haemoglobin ≥ 9g/dL;
- Adequate renal function, defined as estimated serum creatinine clearance > 45mL/minute calculated using Cockcroft-Gault equation
- Adequate coagulation function, defined as:
- International Normalised Ration <1.5 x upper limit of normal (ULN) for that laboratory
- Partial thromboplastin time <1.5 x ULN
- Exception: monitoring parameters must be within therapeutic range for subjects receiving anti-coagulation therapy
- Adequate hepatic function, defined as:
- Total bilirubin < 1.5 x ULN unless considered due to Gilbert's disease;
- Alanine aminotransferase and aspartate aminotransferase < 1.5 x ULN or < 3 x ULN with documented liver metastases;
- Recovery from the toxicities of previous anti-cancer drugs or radiotherapy to Grade 0 or 1 (or to baseline if condition was pre-existing);
- A female subject is eligible to participate if she in not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- Not of childbearing potential, defined as surgically sterile (documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or postmenopausal *no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; however, in the absence of 12 months of amenorrhea, a single FSH measurement is sufficient);
- Of childbearing potential and agrees to use a highly effective method of contraception consistently during the treatment period and for at least 60 days after that dose of study treatment;
- A male subject with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception during the treatment period and for at least 60 days after the last dose of study treatment and refrains from donating sperm during this period;
- Agree to increase oral sugar intake during the treatment period.
Who cannot join
- Presence or history of brain metastases or abscess;
- Presence of known or suspected ongoing ischemia of non-tumor tissues that may be inadvertently colonized by bacteria including:
- Ischemic peripheral vascular disease, myocardial infarction within the past 6 months;
- Congestive heart failure > class II New York Heart Association;
- Unstable angina (anginal symptoms at rest) or new onset angina (commenced within the last 3 months);
- Patent foramen ovale;
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- Prior history or current bacterial endocarditis,
- Existing thrombus (either arterial or venous) as well as known history of deep vein thrombosis, permanent pacemakers, automated implantable cardioverter-defibrillators, left ventricular assist devices, or other intravascular cardiac device, known arteriovenous malformations;
- Cerebrovascular event, including transient ischemic attacks within the past 6 months;
- An artificial implant that cannot be easily removed (e.g., heart valves, prosthetic hips or knees, or other devices) that could allow inadvertent bacterial colonization;
- Abnormal fluid collections (e.g. ascites and/or pericardial and/or pleural effusions) that could allow inadvertent bacterial colonization;
- Has tumor masses immediately adjacent to, and/or with infiltration into, large arteries, veins or vessels;
- Bacteremia and/or abscess and/or treatment with systemic (oral or IV) antibiotics within 4 weeks prior to dosing;
- Anticipated exposure to systemic antibiotics within 4 weeks of dosing;
- Positive for human immunodeficiency virus, hepatitis B or hepatitis C at screening;
- Treatment with radiation therapy to a visceral organ or tumors within 2 weeks prior to dosing;
- Treatment with any programmed cell death protein-1 and/or programmed cell death ligand 1 inhibiting agent within 2 weeks prior to dosing;
- Treatment with any investigational agent for treatment of cancer or related comorbidity within 4 weeks prior to dosing;
- Treatment with any chemotherapy or major surgery within 6 weeks prior to dosing;
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to agent(s) or other agents used in study;
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, autoimmune disorder, or psychiatric illness/social situations that would limit compliance with study requirements;
- Any other reason that, in the opinion of the investigator and/or sponsor, precludes the subject from participating in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-centre, Open-label, Phase I Trial of bacTRL-IL-12 in Adult Subjects With Advanced, Treatment-refractory Solid Tumours
This study is as an open-label study to be conducted at multiple study centres across New Zealand and Australia designed to characterise the safety, tolerability and preliminary assessment of the anti-tumour efficacy of bacTRL-IL-12 after intravenous (IV) infusion.
The study will consist of a screening period (Day -14 to Day -2), treatment and observation (Day 1 to Day 22), safety follow-up period (Day 28 to Day 31), and efficacy follow-up period (until progression, death, revocation of consent, or lost to follow-up).
- Conditions
- Cancer - Solid Tumours
- Being tested
- bacTRL-IL-12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bacTRL-IL-12Drug
bacTRL-IL-12 is a live, genetically modified Bifidobacterium longum (B longum), for administration via IV infusion. The probiotic bacteria selectively colonize solid tumour tissues and are engineered to deliver genetic material encoding the pro-inflammatory transgene Interleukin-12 (IL-12). Plasmid DNA encoding the IL-12 transgene is delivered to the patient's cells within the tumor microenvironment, whereupon IL-12 is expressed to stimulate local and systemic anti-tumour immune responses.
| Study group | Role | What they receive |
|---|---|---|
| bacTRL-IL-12 | Experimental | single-dose, 1 mL IV infusion of bacTRL-IL-12 Receives: Drug: bacTRL-IL-12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events according to NCI CTCAE
Measured: day 31 safety follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start5 Aug 2019
- Primary completion29 Dec 2020
- Study completion29 Dec 2020
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer - Solid TumoursStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- IQVIA Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025307
- Sponsor's protocol ID
- bacTRL-IL-12-001
- Status last verified
- Mar 2021
- First submitted
- 11 Jul 2019
- Last updated
- 12 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Open-label, Phase I Trial of bacTRL-IL-12 in Adult Subjects With Advanced, Treatment-refractory Solid Tumours
- ClinicalTrials.gov ID
- NCT04025307
- Acronym / sponsor ID
- bacTRL-IL-12-001
- Conditions
- Cancer - Solid Tumours
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 5 participants (actual)
- Lead sponsor
- IQVIA Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 29 Dec 2020 (actual)
- Study completion
- 29 Dec 2020 (actual)
- First posted
- 18 Jul 2019 (actual)
- 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.
This study is as an open-label study to be conducted at multiple study centres across New Zealand and Australia designed to characterise the safety, tolerability and preliminary assessment of the anti-tumour efficacy of bacTRL-IL-12 after intravenous (IV) infusion.
The study will consist of a screening period (Day -14 to Day -2), treatment and observation (Day 1 to Day 22), safety follow-up period (Day 28 to Day 31), and efficacy follow-up period (until progression, death, revocation of consent, or lost to follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bacTRL-IL-12 | Experimental | Drug: bacTRL-IL-12single-dose, 1 mL IV infusion of bacTRL-IL-12 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Adults (18 years or older);
- Capable of providing informed consent;
- Advanced and/or metastatic, histologically-documented, measurable (per iRECIST) solid tumours for which there are no other standard therapy options available that are acceptable to the subject;
- Eastern Cooperative Oncology Group status of 0 or 1;
- Adequate haematological status (regardless of transfusions) defined as:
Key exclusion criteria (22 listed)
- Presence or history of brain metastases or abscess;
- Presence of known or suspected ongoing ischemia of non-tumor tissues that may be inadvertently colonized by bacteria including:
- An artificial implant that cannot be easily removed (e.g., heart valves, prosthetic hips or knees, or other devices) that could allow inadvertent bacterial colonization;
- Abnormal fluid collections (e.g. ascites and/or pericardial and/or pleural effusions) that could allow inadvertent bacterial colonization;
- Has tumor masses immediately adjacent to, and/or with infiltration into, large arteries, veins or vessels;
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 |
|---|---|---|
| bacTRL-IL-12bacTRL-IL-12 is a live, genetically modified Bifidobacterium longum (B longum), for administration via IV infusion. The probiotic bacteria selectively colonize solid tumour tissues and are engineered to deliver genetic material encoding the pro-inflammatory transgene Interleukin-12 (IL-12). Plasmid DNA encoding the IL-12 transgene is delivered to the patient's cells within the tumor microenvironment, whereupon IL-12 is expressed to stimulate local and systemic anti-tumour immune responses. | Drug | bacTRL-IL-12 |
Primary outcome
Incidence and severity of adverse events according to NCI CTCAE
Time frame: day 31 safety follow up
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bacTRL-IL-12 in people with Cancer - Solid Tumours, run by IQVIA Pty Ltd at 1 site in Australia.
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 22 inclusion and 22 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: stopped early, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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 was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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?
Incidence and severity of adverse events according to NCI CTCAE (time frame: day 31 safety follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2021.