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ATOR-1015 First-in-human Study

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ClinicalTrials.gov Identifier: NCT03782467
Recruitment Status : Recruiting
First Posted : December 20, 2018
Last Update Posted : February 21, 2019
Sponsor:
Information provided by (Responsible Party):
Alligator Bioscience AB

Study Description
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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.

Condition or disease Intervention/treatment Phase
Solid Tumor Neoplasms Biological: ATOR-1015 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023
Arms and Interventions
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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)


Outcome Measures
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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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782467


Contacts
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Contact: Philip Van Der Veen +44 (0) 1293 510319 PVanDerVeen@theradex.co.uk
Contact: Erika Bågeman Erb@AlligatorBioscience.com

Locations
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Denmark
Phase 1 Unit, Department of Oncology, Rigshospitalet Not yet recruiting
Copenhagen, Denmark, DK-2100
Contact: Kristoffer Staal Rohrberg         
Center for Cancer Research, Department of Oncology, Herlev Hospital Not yet recruiting
Herlev, Denmark, DK-2730
Contact: Dorte Nielsen, Dr         
Sweden
Kliniska Prövningsenheten, Kliniska Studier Sverige - Forum Söder, Skånes Universitetssjukhus Not yet recruiting
Lund, Sweden, SE-221 85
Contact: Ana Caneiro, Dr         
Centrum för Kliniska Cancerstudier (CKC), Fas 1-enheten, Karolinska Universitetssjukhuset Recruiting
Solna, Sweden, SE-171 64
Principal Investigator: Jeffrey Yachnin, Dr         
Onkologavdelningen, Akademiska Sjukhuset Recruiting
Uppsala, Sweden, SE-751 85
Contact: Gustav Ullenhag, Dr         
Sponsors and Collaborators
Alligator Bioscience AB
Investigators
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Study Director: Charlotte Russell, MD, DMSc Alligator Bioscience AB
Principal Investigator: Jeffrey Yachnin, Dr Centrum för Kliniska Cancerstudier (CKC), Karolinska Universitetssjukhuset
More Information
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Responsible Party: Alligator Bioscience AB
ClinicalTrials.gov Identifier: NCT03782467     History of Changes
Other Study ID Numbers: A-18-1015-C-01
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No