NeoplasmsPhase 1NCT02379741
ADC-1013 First-in-Human Study
A Phase 1 study testing ADC-1013 in people with Neoplasms and Solid Tumors, run by Alligator Bioscience AB at 5 sites in 3 countries.
Trial summary
The purpose of this study is to determine whether ADC-1013 (an agonistic human monoclonal IgG1 anti-CD40 antibody) is safe and tolerable when administered intratumorally (as repeated injections directly into the tumor tissue) or intravenously (as repeated doses directly into a vein) in patients with advanced solid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Solid Tumors
- What is being tested?
- ADC-1013
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Apr 2015to 8 Mar 2017
- 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
Major Inclusion Criteria:
- Diagnosis of advanced solid tumor disease
- Performance status of 0-1 on the ECOG scale
- Life expectancy of at least 3 months
Major Exclusion Criteria:
- Organ transplant recipient
- Autoimmune disorder
- Other malignancy (except localized prostate cancer, adequately treated basal skin cancer or carcinoma in-situ of the cervix)
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Sweden2 sites
Kliniska prövningsenheten (KPE), Karolinska University Hospital
Solna, Stockholm County, SE-171 76
Department of Oncology, Uppsala University Hospital
Uppsala, Uppsala County, SE-751 85
United Kingdom2 sites
The Clatterbridge Cancer Centre
Bebington, Wirral, CH63 4JY
Department of Oncology, Queen Elisabeth Hospital
Edgbaston, Birmingham, B15 2TH
Denmark1 site
Center for Cancer Research, Department of Oncology, Herlev Hospital
Herlev, Herlev, DK-2730
About this study
Official title: A First-in-human, Multicenter, Open-label, Multiple Ascending Dose Phase I Study in Patients With Advanced Solid Tumors to Determine the Safety, Pharmacokinetics and Pharmacodynamics of Intratumorally or Intravenously Administered ADC-1013
The purpose of this study is to determine whether ADC-1013 (an agonistic human monoclonal IgG1 anti-CD40 antibody) is safe and tolerable when administered intratumorally (as repeated injections directly into the tumor tissue) or intravenously (as repeated doses directly into a vein) in patients with advanced solid tumors.
- Conditions
- Neoplasms, Solid Tumors
- Being tested
- ADC-1013
- Keywords
- Antibodies, Antibodies, Monoclonal, Antineoplastic agent, Physiological effects of drugs, Therapeutic uses, Clinical Trial, Phase I, Immunotherapy, Active, CD40 Antigen, Immunologic Factors, Injections, Intralesional
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADC-1013Biological
Agonistic human monoclonal IgG1 anti-CD40 antibody
| Study group | Role | What they receive |
|---|---|---|
| ADC-1013 intratumoral | Experimental | ADC-1013 (agonistic human monoclonal IgG1 anti-CD40 antibody) administered by intratumoral injection every second week for 8 weeks. Patients that do not progress will be offered continued treatment until complete response, confirmed progressive disease, or clinical deterioration. Receives: Biological: ADC-1013 |
| ADC-1013 intravenous | Experimental | ADC-1013 (agonistic human monoclonal IgG1 anti-CD40 antibody) administered by intravenous infusion every second week until complete response, confirmed progressive disease, or clinical deterioration. Receives: Biological: ADC-1013 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of increasing doses of ADC-1013, assessed by medical review of AE reports and vital signs measurements (blood pressure, pulse rate, body temperature), physical examinations, ECGs and clinical laboratory tests.
Dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and recommended Phase 2 dose of ADC-1013 administered intratumorally or intravenously will be defined.
Measured: From start of study until end of study (appr 28 days after last dose)
Secondary outcomes (3)
Pharmacokinetics of ADC-1013 after single and repeated administrations assessed by the following parameters: Cmax, Tmax, elimination half-life, AUC0-∞, total serum clearance (CL) and the volume of distribution at steady state (Vss).
Measured: From first dose until 55 days after first dose
Immunogenicity of ADC-1013 after repeated administrations assessed by anti-drug antibody (ADA) titers in serum
Measured: From first dose until end of study (appr 28 days after last dose)
Clinical efficacy (i.e. anti-tumor activity) of ADC-1013 assessed by immune-related RECIST (irRECIST) and RECIST 1.1.
Measured: From start of study until end of study (appr 28 days after last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startApr 2015
- Primary completion8 Mar 2017
- Study completion8 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alligator Bioscience AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Per Norlén, MD, PhD, Study director, Alligator Biosciene AB, SwedenDorte Nielsen, MD, PhD, Study chair, Department of Oncology Herlev Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379741
- Sponsor's protocol ID
- A-14-1013-C-01
- Status last verified
- Mar 2017
- First submitted
- 16 Feb 2015
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Multicenter, Open-label, Multiple Ascending Dose Phase I Study in Patients With Advanced Solid Tumors to Determine the Safety, Pharmacokinetics and Pharmacodynamics of Intratumorally or Intravenously Administered ADC-1013
- ClinicalTrials.gov ID
- NCT02379741
- Acronym / sponsor ID
- A-14-1013-C-01
- Conditions
- Neoplasms, Solid Tumors
- Keywords
- Antibodies, Antibodies, Monoclonal, Antineoplastic agent, Physiological effects of drugs, Therapeutic uses, Clinical Trial, Phase I, Immunotherapy, Active, CD40 Antigen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Alligator Bioscience ABIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- 8 Mar 2017 (actual)
- Study completion
- 8 Mar 2017 (actual)
- First posted
- 5 Mar 2015 (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.
The purpose of this study is to determine whether ADC-1013 (an agonistic human monoclonal IgG1 anti-CD40 antibody) is safe and tolerable when administered intratumorally (as repeated injections directly into the tumor tissue) or intravenously (as repeated doses directly into a vein) in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADC-1013 intratumoral | Experimental | Biological: ADC-1013ADC-1013 (agonistic human monoclonal IgG1 anti-CD40 antibody) administered by intratumoral injection every second week for 8 weeks. Patients that do not progress will be offered continued treatment until complete response, confirmed progressive disease, or clinical deterioration. |
| ADC-1013 intravenous | Experimental | Biological: ADC-1013ADC-1013 (agonistic human monoclonal IgG1 anti-CD40 antibody) administered by intravenous infusion every second week until complete response, confirmed progressive disease, or clinical deterioration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| ADC-1013Agonistic human monoclonal IgG1 anti-CD40 antibody | Biological | ADC-1013 intratumoral, ADC-1013 intravenous |
Primary outcome
Safety and tolerability of increasing doses of ADC-1013, assessed by medical review of AE reports and vital signs measurements (blood pressure, pulse rate, body temperature), physical examinations, ECGs and clinical laboratory tests.
Time frame: From start of study until end of study (appr 28 days after last dose)
Dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and recommended Phase 2 dose of ADC-1013 administered intratumorally or intravenously will be defined.
3 secondary outcomes
Pharmacokinetics of ADC-1013 after single and repeated administrations assessed by the following parameters: Cmax, Tmax, elimination half-life, AUC0-∞, total serum clearance (CL) and the volume of distribution at steady state (Vss).
Time frame: From first dose until 55 days after first dose
Immunogenicity of ADC-1013 after repeated administrations assessed by anti-drug antibody (ADA) titers in serum
Time frame: From first dose until end of study (appr 28 days after last dose)
Clinical efficacy (i.e. anti-tumor activity) of ADC-1013 assessed by immune-related RECIST (irRECIST) and RECIST 1.1.
Time frame: From start of study until end of study (appr 28 days after last dose)
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 27 Mar 2017.
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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.
Per Norlén, MD, PhD study director
Alligator Biosciene AB, Sweden
Dorte Nielsen, MD, PhD study chair
Department of Oncology Herlev Hospital, Denmark
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ADC-1013 in people with Neoplasms and Solid Tumors, run by Alligator Bioscience AB at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 27 Mar 2017. 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 Sweden, United Kingdom, Denmark. 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?
Safety and tolerability of increasing doses of ADC-1013, assessed by medical review of AE reports and vital signs measurements (blood pressure, pulse rate, body temperature), physical examinations, ECGs and clinical laboratory tests. (time frame: From start of study until end of study (appr 28 days after last dose)). 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 27 Mar 2017.