Phase 1 Study in Patients With Advanced and/or Refractory Solid Malignancies to Evaluate the Safety of ATOR-1015

NCT ID: NCT03782467

Last Updated: 2022-08-18

Study Results

Results pending

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.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-30

Study Completion Date

2021-03-03

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

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.

Solid Tumor Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ATOR-1015

ATOR-1015 administered by intravenous infusions every 2 weeks until confirmed progressive disease, unacceptable toxicity or withdrawal of consent.

Group Type EXPERIMENTAL

ATOR-1015

Intervention Type BIOLOGICAL

Bispecific human monoclonal antibody targeting cytotoxic T-lymphocyte associated protein 4 (CTLA-4) and OX40 (also known as CD134)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ATOR-1015

Bispecific human monoclonal antibody targeting cytotoxic T-lymphocyte associated protein 4 (CTLA-4) and OX40 (also known as CD134)

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Exclusion Criteria

* Organ transplant recipient
* Active autoimmune disorder
* Other malignancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alligator Bioscience AB

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Malin Carlsson, MD

Role: STUDY_DIRECTOR

Alligator Bioscience AB

Jeffrey Yachnin, Dr

Role: PRINCIPAL_INVESTIGATOR

Centrum för Kliniska Cancerstudier (CKC), Karolinska Universitetssjukhuset

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Phase 1 Unit, Department of Oncology, Rigshospitalet

Copenhagen, , Denmark

Site Status

Center for Cancer Research, Department of Oncology, Herlev Hospital

Herlev, , Denmark

Site Status

Kliniska Prövningsenheten, Kliniska Studier Sverige - Forum Söder, Skånes Universitetssjukhus

Lund, , Sweden

Site Status

Centrum för Kliniska Cancerstudier (CKC), Fas 1-enheten, Karolinska Universitetssjukhuset

Solna, , Sweden

Site Status

Onkologavdelningen, Akademiska Sjukhuset

Uppsala, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30975201 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A-18-1015-C-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Phase 1-2 Study of ST101 in Patients With Advanced Solid Tumors
NCT04478279 ACTIVE_NOT_RECRUITING PHASE1/PHASE2
ADC-1013 First-in-Human Study
NCT02379741 COMPLETED PHASE1
Study Of ATRN-119 In Patients With Advanced Solid Tumors
NCT04905914 ACTIVE_NOT_RECRUITING PHASE1/PHASE2