Phase 1 Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of ATOR-1017
NCT ID: NCT04144842
Last Updated: 2023-04-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2019-12-03
2023-03-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Phase 1 Study in Patients With Advanced and/or Refractory Solid Malignancies to Evaluate the Safety of ATOR-1015
NCT03782467
AZD6244 (ARRY-142886) Solid Oral Dosage Formulation in Participants With Advanced Solid Malignancies
NCT00463814
A Phase 1b Trial of ATRC-101 in Adults With Advanced Solid Malignancies
NCT04244552
Study of AS1411 in Advanced Solid Tumours
NCT00881244
ADC-1013 First-in-Human Study
NCT02379741
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ATOR-1017
ATOR-1017 administered by intravenous infusions every 3 weeks until confirmed progressive disease, clear clinical deterioration, unacceptable toxicity or withdrawal of consent
ATOR-1017
ATOR-1017 is a human monoclonal antibody targeting 4-1BB (CD137)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ATOR-1017
ATOR-1017 is a human monoclonal antibody targeting 4-1BB (CD137)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Has a diagnosis of advanced and/or refractory solid malignancy (histologically or cytologically documented)
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Has a minimum of one measurable tumor lesion
* Has acceptable hematologic and clinical chemistry laboratory values
Exclusion Criteria
* Has not recovered from AEs to at least grade 1 by CTCAE version 5.0 due to prior anti-cancer medications
* Has symptomatic, steroid-dependent or progressive brain metastasis/metastases
* Has a history of another primary malignancy, except for: a) Malignancy treated with curative intent and with no known active disease within 2 years prior to first dose of ATOR-1017, b) Adequately treated non-invasive basal skin cancer or squamous cell skin carcinoma, c) Adequately treated uterine cervical cancer stage 1B or less
* Has an autoimmune disorder requiring immune modulating treatment during the last 2 years
* Receives treatment with systemic immunosuppressant medication (except for inhaled and low dose systemic corticosteroids, i.e. ≤10 mg prednisolone or equivalent per day)
* Is a female patient who is pregnant or nursing
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alligator Bioscience AB
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sumeet Ambarkhane, MD
Role: STUDY_DIRECTOR
Alligator Bioscience AB
Gustav Ullenhag, Dr
Role: PRINCIPAL_INVESTIGATOR
Department of Oncology, Uppsala University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Oncology, Skåne University Hospital
Lund, , Sweden
Fas 1-enheten, Centrum för Kliniska Cancerstudier, Karolinska Universitetssjukhuset
Solna, , Sweden
Department of Oncology, Uppsala University Hospital
Uppsala, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
A-19-1017-C-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.