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

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 Overview

• Status: Completed
• Conditions: Neoplasms; Solid Tumor
• Intervention / Treatment: Biological: ATOR-1015

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, DK-2100
    • Phase 1 Unit, Department of Oncology, Rigshospitalet
  • Herlev, Denmark, DK-2730
    • Center for Cancer Research, Department of Oncology, Herlev Hospital
• Sweden
  • Lund, Sweden, SE-221 85
    • Kliniska Prövningsenheten, Kliniska Studier Sverige - Forum Söder, Skånes Universitetssjukhus
  • Solna, Sweden, SE-171 64
    • Centrum för Kliniska Cancerstudier (CKC), Fas 1-enheten, Karolinska Universitetssjukhuset
  • Uppsala, Sweden, SE-751 85
    • Onkologavdelningen, Akademiska Sjukhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ATOR-1015; ATOR-1015 administered by intravenous infusions every 2 weeks until confirmed progressive disease, unacceptable toxicity or withdrawal of consent.	Biological: ATOR-1015; Bispecific human monoclonal antibody targeting cytotoxic T-lymphocyte associated protein 4 (CTLA-4) and OX40 (also known as CD134)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Levels of antibodies to ATOR-1015 will be evaluated	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	From start of study until end of study (28-56 days after last dose)

Collaborators and Investigators

• Sponsor: Alligator Bioscience AB
• Investigators: Study Director: Malin Carlsson, MD, Alligator Bioscience AB; Principal Investigator: Jeffrey Yachnin, Dr, Centrum för Kliniska Cancerstudier (CKC), Karolinska Universitetssjukhuset

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 30, 2019
• Primary Completion (ACTUAL): March 3, 2021
• Study Completion (ACTUAL): March 3, 2021

Study Registration Dates

• First Submitted: December 14, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (ACTUAL): December 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: A-18-1015-C-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No