Solid TumorPhase 1NCT03782467
Phase 1 Study in Patients With Advanced and/or Refractory Solid Malignancies to Evaluate the Safety of ATOR-1015
A Phase 1 study testing ATOR-1015 in people with Solid Tumor and Neoplasms, run by Alligator Bioscience AB at 5 sites in 2 countries.
Trial summary
The aim of the study is to investigate the safety and tolerability of ATOR-1015 when administered as repeated intravenous infusions to patients with advanced and/or refractory solid malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Neoplasms
- What is being tested?
- ATOR-1015
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 30 Jan 2019to 3 Mar 2021
- 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 and/or refractory solid malignancy
- Eastern Cooperation Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 3 months
Major Exclusion Criteria:
- Organ transplant recipient
- Active autoimmune disorder
- Other malignancy
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Sweden3 sites
Kliniska Prövningsenheten, Kliniska Studier Sverige - Forum Söder, Skånes Universitetssjukhus
Lund, SE-221 85
Centrum för Kliniska Cancerstudier (CKC), Fas 1-enheten, Karolinska Universitetssjukhuset
Solna, SE-171 64
Onkologavdelningen, Akademiska Sjukhuset
Uppsala, SE-751 85
Denmark2 sites
Phase 1 Unit, Department of Oncology, Rigshospitalet
Copenhagen, DK-2100
Center for Cancer Research, Department of Oncology, Herlev Hospital
Herlev, DK-2730
About this study
Official title: A First-in-human, Multicenter, Open-label, Phase 1 Study in Patients With Advanced and/or Refractory Solid Malignancies to Evaluate the Safety of Intravenously Administered ATOR-1015
The aim of the study is to investigate the safety and tolerability of ATOR-1015 when administered as repeated intravenous infusions to patients with advanced and/or refractory solid malignancies.
- Conditions
- Solid Tumor, Neoplasms
- Being tested
- ATOR-1015
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATOR-1015Biological
Bispecific human monoclonal antibody targeting cytotoxic T-lymphocyte associated protein 4 (CTLA-4) and OX40 (also known as CD134)
| Study group | Role | What they receive |
|---|---|---|
| ATOR-1015 | Experimental | ATOR-1015 administered by intravenous infusions every 2 weeks until confirmed progressive disease, unacceptable toxicity or withdrawal of consent. Receives: Biological: ATOR-1015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Number of participants with treatment-related AEs assessed by CTCAE v5.0
Measured: From start of study until 28 days after last dose
Safety and tolerability: Vital signs
Vital signs include blood pressure, pulse rate, oxygen saturation and body temperature. Clinically significant abnormal findings will be reported as AEs.
Measured: From start of study until end of study (28-56 days after last dose)
Safety and tolerability: Physical examination
Physical examination will as a minimum include examination of mouth, throat, lymph nodes, respiratory, cardiovascular system, abdomen, extremities, neurological system and skin. Clinically significant abnormal findings will be reported as AEs.
Measured: From start of study until end of study (28-56 days after last dose)
Safety and tolerability: 12-lead electrocardiogram (ECG)
Clinically significant abnormal ECG findings will be reported as AEs.
Measured: From start of study until end of study (28-56 days after last dose)
Safety and tolerability: Clinical laboratory tests
Clinical laboratory tests include clinical chemistry, hematology, coagulation, hormones and urinalysis.
Measured: From start of study until end of study (28-56 days after last dose)
Secondary outcomes (5)
Pharmacokinetics: Maximum observed serum concentration of ATOR-1015 (Cmax)
Measured: From start of study until end of study (28-56 days after last dose)
Pharmacokinetics: Time to Cmax
Measured: From start of study until end of study (28-56 days after last dose)
Pharmacokinetics: Area under the ATOR-1015 serum concentration-time curve (AUC)
Measured: From start of study until end of study (28-56 days after last dose)
Immunogenicity: Anti-drug antibody (ADA) titer in serum
Levels of antibodies to ATOR-1015 will be evaluated
Measured: From start of study until end of study (28-56 days after last dose)
Clinical efficacy: Anti-tumor activity assessed by response evaluation criteria in solid tumors for immune-based therapeutics (iRECIST)
Computed tomography (CT) scans of tumors will be evaluated according to iRECIST
Measured: From start of study until end of study (28-56 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 posted20 Dec 2018
- Study start30 Jan 2019
- Primary completion3 Mar 2021
- Study completion3 Mar 2021
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 Solid TumorStudies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alligator Bioscience AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Malin Carlsson, MD, Study director, Alligator Bioscience ABJeffrey Yachnin, Dr, Principal investigator, Centrum för Kliniska Cancerstudier (CKC), Karolinska Universitetssjukhuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782467
- Sponsor's protocol ID
- A-18-1015-C-01
- Status last verified
- Aug 2022
- First submitted
- 14 Dec 2018
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kvarnhammar AM, Veitonmaki N, Hagerbrand K, Dahlman A, Smith KE, Fritzell S, von Schantz L, Thagesson M, Werchau D, Smedenfors K, Johansson M, Rosen A, Aberg I, Winnerstam M, Nyblom E, Barchan K, Furebring C, Norlen P, Ellmark P. The CTLA-4 x OX40 bispecific antibody ATOR-1015 induces anti-tumor effects through tumor-directed immune activation. J Immunother Cancer. 2019 Apr 11;7(1):103. doi: 10.1186/s40425-019-0570-8.
PubMed 30975201
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human, Multicenter, Open-label, Phase 1 Study in Patients With Advanced and/or Refractory Solid Malignancies to Evaluate the Safety of Intravenously Administered ATOR-1015
- ClinicalTrials.gov ID
- NCT03782467
- Acronym / sponsor ID
- A-18-1015-C-01
- Conditions
- Solid Tumor, Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Alligator Bioscience ABIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 3 Mar 2021 (actual)
- First posted
- 20 Dec 2018 (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.
The aim of the study is to investigate the safety and tolerability of ATOR-1015 when administered as repeated intravenous infusions to patients with advanced and/or refractory solid malignancies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATOR-1015 | Experimental | Biological: ATOR-1015ATOR-1015 administered by intravenous infusions every 2 weeks until confirmed progressive disease, unacceptable toxicity or withdrawal of consent. |
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 |
|---|---|---|
| ATOR-1015Bispecific human monoclonal antibody targeting cytotoxic T-lymphocyte associated protein 4 (CTLA-4) and OX40 (also known as CD134) | Biological | ATOR-1015 |
Primary outcome
Safety and tolerability: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: From start of study until 28 days after last dose
Number of participants with treatment-related AEs assessed by CTCAE v5.0
Safety and tolerability: Vital signs
Time frame: From start of study until end of study (28-56 days after last dose)
Vital signs include blood pressure, pulse rate, oxygen saturation and body temperature. Clinically significant abnormal findings will be reported as AEs.
Safety and tolerability: Physical examination
Time frame: From start of study until end of study (28-56 days after last dose)
Physical examination will as a minimum include examination of mouth, throat, lymph nodes, respiratory, cardiovascular system, abdomen, extremities, neurological system and skin. Clinically significant abnormal findings will be reported as AEs.
Safety and tolerability: 12-lead electrocardiogram (ECG)
Time frame: From start of study until end of study (28-56 days after last dose)
Clinically significant abnormal ECG findings will be reported as AEs.
Safety and tolerability: Clinical laboratory tests
Time frame: From start of study until end of study (28-56 days after last dose)
Clinical laboratory tests include clinical chemistry, hematology, coagulation, hormones and urinalysis.
5 secondary outcomes
Pharmacokinetics: Maximum observed serum concentration of ATOR-1015 (Cmax)
Time frame: From start of study until end of study (28-56 days after last dose)
Pharmacokinetics: Time to Cmax
Time frame: From start of study until end of study (28-56 days after last dose)
Pharmacokinetics: Area under the ATOR-1015 serum concentration-time curve (AUC)
Time frame: From start of study until end of study (28-56 days after last dose)
Immunogenicity: Anti-drug antibody (ADA) titer in serum
Time frame: From start of study until end of study (28-56 days after last dose)
Clinical efficacy: Anti-tumor activity assessed by response evaluation criteria in solid tumors for immune-based therapeutics (iRECIST)
Time frame: From start of study until end of study (28-56 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 18 Aug 2022.
- Derived from this study: PubMed 30975201Kvarnhammar AM, Veitonmaki N, Hagerbrand K, Dahlman A, Smith KE, Fritzell S, von Schantz L, Thagesson M, Werchau D, Smedenfors K, Johansson M, Rosen A, Aberg I, Winnerstam M, Nyblom E, Barchan K, Furebring C, Norlen P, Ellmark P. The CTLA-4 x OX40 bispecific antibody ATOR-1015 induces anti-tumor effects through tumor-directed immune activation. J Immunother Cancer. 2019 Apr 11;7(1):103. doi: 10.1186/s40425-019-0570-8.
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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.
Malin Carlsson, MD study director
Alligator Bioscience AB
Jeffrey Yachnin, Dr principal investigator
Centrum för Kliniska Cancerstudier (CKC), Karolinska Universitetssjukhuset
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATOR-1015 in people with Solid Tumor and Neoplasms, run by Alligator Bioscience AB at 5 sites in 2 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 18 Aug 2022. 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, 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: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (time frame: From start of study until 28 days after last dose). The study lists 5 primary outcomes in all. 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 NCT03782467, 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 18 Aug 2022.