Colorectal NeoplasmsPhase 1NCT03189030
Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer
A Phase 1 study testing pLADD in people with Colorectal Neoplasms, run by Aduro Biotech, Inc. at 5 sites in United States.
Trial summary
This study will evaluate the safety and tolerability of a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD) treatment in adults with metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- pLADD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 5 sitesUnited States
- Study dates
- 2 May 2017to 2 Sep 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
- metastatic colorectal cancer (mCRC) that is microsatellite stable (MSS)
- able to provide adequate tumor tissue from at least 1 accessible tumor site
- completed or have developed intolerance to a course of oxaliplatin- or irinotecan-based frontline therapy at Screening
- on maintenance standard-of-care chemotherapies or on treatment holiday
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
- adequate organ function
- progression of disease at the time of Enrollment
Who cannot join
- BRAF V600E mutation
- known allergy to both penicillin and sulfa drugs
- implanted devices that cannot be easily removed
- immunodeficiency, immune compromised state or receiving immunosuppressive therapy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Mary Crowley Cancer Research - Medical City
Dallas, Texas, 75230
City of Hope National Medical Center
Duarte, California, 91010
University of California Los Angeles
Los Angeles, California, 90095
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Stanford
Stanford, California, 94305
About this study
Official title: A Phase 1 Safety and Tolerability Study of Personalized Live, Attenuated, Double-Deleted Listeria Monocytogenes (pLADD) Immunotherapy in Adults With Metastatic Colorectal Cancer
This study will evaluate the safety and tolerability of a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD) treatment in adults with metastatic colorectal cancer.
Read the detailed description
This single arm study is designed to evaluate the safety and tolerability of a personalized treatment in adults with metastatic colorectal cancer by first analyzing the expression of tumor-associated antigens and then treating the patients with a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD)-based immunotherapy. pLADD is based on the attenuated form of Listeria monocytogenes that has been genetically modified to reduce its ability to cause disease, while maintaining its ability to stimulate a potent immune response. pLADD is manufactured using patient-specific antigens and is therefore individualized to each patient.
- Conditions
- Colorectal Neoplasms
- Being tested
- pLADD
- Keywords
- metastatic, microsatellite stable (MSS)
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pLADDBiological
via IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | pLADD treatment cycle is once every 3 weeks; starting dose 1×10^8 colony-forming units (CFU) administered IV over 1 hour, and if tolerated increasing to 1×10^9 CFU Receives: Biological: pLADD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Number of patients with treatment-related adverse events as assessed by CTCAE v 4.0
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start2 May 2017
- Primary completion15 Oct 2019
- Study completion2 Sep 2020
Why it stopped: Study terminated due to business realignment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aduro Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hanlee P. Ji, MD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189030
- Sponsor's protocol ID
- ADU-CL-12
- Status last verified
- Sep 2020
- First submitted
- 14 Jun 2017
- Last updated
- 1 Oct 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Safety and Tolerability Study of Personalized Live, Attenuated, Double-Deleted Listeria Monocytogenes (pLADD) Immunotherapy in Adults With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03189030
- Acronym / sponsor ID
- ADU-CL-12
- Conditions
- Colorectal Neoplasms
- Keywords
- metastatic, microsatellite stable (MSS)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to business realignment
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Aduro Biotech, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hanlee P. Ji, MD
- Study start
- 2 May 2017 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 2 Sep 2020 (actual)
- First posted
- 16 Jun 2017 (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 will evaluate the safety and tolerability of a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD) treatment in adults with metastatic colorectal cancer.
Detailed description
This single arm study is designed to evaluate the safety and tolerability of a personalized treatment in adults with metastatic colorectal cancer by first analyzing the expression of tumor-associated antigens and then treating the patients with a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD)-based immunotherapy. pLADD is based on the attenuated form of Listeria monocytogenes that has been genetically modified to reduce its ability to cause disease, while maintaining its ability to stimulate a potent immune response. pLADD is manufactured using patient-specific antigens and is therefore individualized to each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Biological: pLADDpLADD treatment cycle is once every 3 weeks; starting dose 1×10^8 colony-forming units (CFU) administered IV over 1 hour, and if tolerated increasing to 1×10^9 CFU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- metastatic colorectal cancer (mCRC) that is microsatellite stable (MSS)
- able to provide adequate tumor tissue from at least 1 accessible tumor site
- completed or have developed intolerance to a course of oxaliplatin- or irinotecan-based frontline therapy at Screening
- on maintenance standard-of-care chemotherapies or on treatment holiday
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
Key exclusion criteria (4 listed)
- BRAF V600E mutation
- known allergy to both penicillin and sulfa drugs
- implanted devices that cannot be easily removed
- immunodeficiency, immune compromised state or receiving immunosuppressive therapy
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 |
|---|---|---|
| pLADDvia IV infusion | Biological | Treatment arm |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time frame: Through study completion, an average of 12 months
Number of patients with treatment-related adverse events as assessed by CTCAE v 4.0
Results and safety
The study was stopped early (reason given: Study terminated due to business realignment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
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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.
5 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 pLADD in people with Colorectal Neoplasms, run by Aduro Biotech, Inc. at 5 sites in United States.
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 7 inclusion and 4 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 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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: Study terminated due to business realignment). 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 of Treatment-Emergent Adverse Events (Safety and Tolerability) (time frame: Through study completion, an average of 12 months). 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 1 Oct 2020.