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History of Changes for Study: NCT03782467
ATOR-1015 First-in-human Study
Latest version (submitted August 16, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 19, 2018 None (earliest Version on record)
2 January 30, 2019 Recruitment Status, Study Status and Contacts/Locations
3 February 20, 2019 Study Status and Contacts/Locations
4 April 8, 2019 Study Status and Contacts/Locations
5 October 9, 2019 Study Status and Contacts/Locations
6 October 30, 2019 Contacts/Locations and Study Status
7 January 12, 2021 Recruitment Status, Study Status, Contacts/Locations and Study Design
8 April 28, 2021 Recruitment Status and Study Status
9 January 14, 2022 Contacts/Locations and Study Status
10 August 16, 2022 Study Status and Study Identification
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Study NCT03782467
Submitted Date:  December 19, 2018 (v1)

Open or close this module Study Identification
Unique Protocol ID: A-18-1015-C-01
Brief Title: ATOR-1015 First-in-human Study
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
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2018
Overall Status: Not yet recruiting
Study Start: December 2018
Primary Completion: February 2023 [Anticipated]
Study Completion: February 2023 [Anticipated]
First Submitted: December 14, 2018
First Submitted that
Met QC Criteria:
December 19, 2018
First Posted: December 20, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
December 19, 2018
Last Update Posted: December 20, 2018 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Alligator Bioscience AB
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Solid Tumor
Neoplasms
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 53 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Safety and tolerability: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
[ Time Frame: From start of study until 28 days after last dose ]

Number of participants with treatment-related AEs assessed by CTCAE v5.0
2. Safety and tolerability: Vital signs
[ Time Frame: From start of study until end of study (28-56 days after last dose) ]

Vital signs include blood pressure, pulse rate, oxygen saturation and body temperature. Clinically significant abnormal findings will be reported as AEs.
3. Safety and tolerability: Physical examination
[ Time Frame: From start of study until end of study (28-56 days after last dose) ]

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.
4. Safety and tolerability: 12-lead electrocardiogram (ECG)
[ Time Frame: From start of study until end of study (28-56 days after last dose) ]

Clinically significant abnormal ECG findings will be reported as AEs.
5. Safety and tolerability: Clinical laboratory tests
[ Time Frame: From start of study until end of study (28-56 days after last dose) ]

Clinical laboratory tests include clinical chemistry, hematology, coagulation, hormones and urinalysis.
Secondary Outcome Measures:
1. Pharmacokinetics: Maximum observed serum concentration of ATOR-1015 (Cmax)
[ Time Frame: From start of study until end of study (28-56 days after last dose) ]

2. Pharmacokinetics: Time to Cmax
[ Time Frame: From start of study until end of study (28-56 days after last dose) ]

3. Pharmacokinetics: Area under the ATOR-1015 serum concentration-time curve (AUC)
[ Time Frame: From start of study until end of study (28-56 days after last dose) ]

4. Immunogenicity: Anti-drug antibody (ADA) titer in serum
[ Time Frame: From start of study until end of study (28-56 days after last dose) ]

Levels of antibodies to ATOR-1015 will be evaluated
5. Clinical efficacy: Anti-tumor activity assessed by response evaluation criteria in solid tumors for immune-based therapeutics (iRECIST)
[ Time Frame: From start of study until end of study (28-56 days after last dose) ]

Computed tomography (CT) scans of tumors will be evaluated according to iRECIST
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Philip Van Der Veen
Telephone: +44 (0) 1293 510319
Email: PVanDerVeen@theradex.co.uk
Central Contact Backup: Erika Bågeman
Email: Erb@AlligatorBioscience.com
Study Officials: Charlotte Russell, MD, DMSc
Study Director
Alligator Bioscience AB
Jeffrey Yachnin, Dr
Principal Investigator
Centrum för Kliniska Cancerstudier (CKC), Karolinska Universitetssjukhuset
Locations: Denmark
Phase 1 Unit, Department of Oncology, Rigshospitalet
Copenhagen, Denmark, DK-2100
Contact:Contact: Kristoffer Staal Rohrberg
Center for Cancer Research, Department of Oncology, Herlev Hospital
Herlev, Denmark, DK-2730
Contact:Contact: Dorte Nielsen, Dr
Sweden
Kliniska Prövningsenheten, Kliniska Studier Sverige - Forum Söder, Skånes Universitetssjukhus
Lund, Sweden, SE-221 85
Contact:Contact: Ana Caneiro, Dr
Centrum för Kliniska Cancerstudier (CKC), Fas 1-enheten, Karolinska Universitetssjukhuset
Solna, Sweden, SE-171 64
Contact:Principal Investigator: Jeffrey Yachnin, Dr
Onkologavdelningen, Akademiska Sjukhuset
Uppsala, Sweden, SE-751 85
Contact:Contact: Gustav Ullenhag, Dr
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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