Phase 1 Study in Patients With Advanced and/or Refractory Solid Malignancies to Evaluate the Safety of ATOR-1015
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
1 other identifier
interventional
33
2 countries
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2019
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2018
CompletedFirst Posted
Study publicly available on registry
December 20, 2018
CompletedStudy Start
First participant enrolled
January 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2021
CompletedAugust 18, 2022
August 1, 2022
2.1 years
December 14, 2018
August 16, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
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
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.
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.
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.
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.
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)
From start of study until end of study (28-56 days after last dose)
Pharmacokinetics: Time to Cmax
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)
From start of study until end of study (28-56 days after last dose)
Immunogenicity: Anti-drug antibody (ADA) titer in serum
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)
From start of study until end of study (28-56 days after last dose)
Study Arms (1)
ATOR-1015
EXPERIMENTALATOR-1015 administered by intravenous infusions every 2 weeks until confirmed progressive disease, unacceptable toxicity or withdrawal of consent.
Interventions
Bispecific human monoclonal antibody targeting cytotoxic T-lymphocyte associated protein 4 (CTLA-4) and OX40 (also known as CD134)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Organ transplant recipient
- Active autoimmune disorder
- Other malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Phase 1 Unit, Department of Oncology, Rigshospitalet
Copenhagen, DK-2100, Denmark
Center for Cancer Research, Department of Oncology, Herlev Hospital
Herlev, DK-2730, Denmark
Kliniska Prövningsenheten, Kliniska Studier Sverige - Forum Söder, Skånes Universitetssjukhus
Lund, SE-221 85, Sweden
Centrum för Kliniska Cancerstudier (CKC), Fas 1-enheten, Karolinska Universitetssjukhuset
Solna, SE-171 64, Sweden
Onkologavdelningen, Akademiska Sjukhuset
Uppsala, SE-751 85, Sweden
Related Publications (1)
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.
PMID: 30975201DERIVED
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Malin Carlsson, MD
Alligator Bioscience AB
- PRINCIPAL INVESTIGATOR
Jeffrey Yachnin, Dr
Centrum för Kliniska Cancerstudier (CKC), Karolinska Universitetssjukhuset
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2018
First Posted
December 20, 2018
Study Start
January 30, 2019
Primary Completion
March 3, 2021
Study Completion
March 3, 2021
Last Updated
August 18, 2022
Record last verified: 2022-08