Clinical trial NCT03782467: Phase 1 Study in Patients With Advanced and/or Refractory Solid Malignancies to Evaluate the Safety of ATOR-1015
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Neoplasms
Lead sponsor: Alligator Bioscience AB
Sponsor class: INDUSTRY
First posted: 2018-12-20
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
timeFrame: From start of study until 28 days after last dose
measure: Safety and tolerability: Vital signs
timeFrame: From start of study until end of study (28-56 days after last dose)
measure: Safety and tolerability: Physical examination
timeFrame: From start of study until end of study (28-56 days after last dose)
measure: Safety and tolerability: 12-lead electrocardiogram (ECG)
timeFrame: From start of study until end of study (28-56 days after last dose)
measure: Safety and tolerability: Clinical laboratory tests
timeFrame: From start of study until end of study (28-56 days after last dose)
Secondary outcomes:
measure: Pharmacokinetics: Maximum observed serum concentration of ATOR-1015 (Cmax)
timeFrame: From start of study until end of study (28-56 days after last dose)
measure: Pharmacokinetics: Time to Cmax
timeFrame: From start of study until end of study (28-56 days after last dose)
measure: Pharmacokinetics: Area under the ATOR-1015 serum concentration-time curve (AUC)
timeFrame: From start of study until end of study (28-56 days after last dose)
measure: Immunogenicity: Anti-drug antibody (ADA) titer in serum
timeFrame: From start of study until end of study (28-56 days after last dose)
measure: Clinical efficacy: Anti-tumor activity assessed by response evaluation criteria in solid tumors for immune-based therapeutics (iRECIST)
timeFrame: From start of study until end of study (28-56 days after last dose)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Phase 1 Unit, Department of Oncology, Rigshospitalet
city: Herlev
country: Denmark
facility: Center for Cancer Research, Department of Oncology, Herlev Hospital
city: Lund
country: Sweden
facility: Kliniska Prövningsenheten, Kliniska Studier Sverige - Forum Söder, Skånes Universitetssjukhus
city: Solna
country: Sweden
facility: Centrum för Kliniska Cancerstudier (CKC), Fas 1-enheten, Karolinska Universitetssjukhuset
city: Uppsala
country: Sweden
facility: Onkologavdelningen, Akademiska Sjukhuset
Study officials:
affiliation: Alligator Bioscience AB
name: Malin Carlsson, MD
role: STUDY_DIRECTOR
affiliation: Centrum för Kliniska Cancerstudier (CKC), Karolinska Universitetssjukhuset
name: Jeffrey Yachnin, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.