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ATOR-1015 First-in-human Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03782467
Recruitment Status : Completed
First Posted : December 20, 2018
Last Update Posted : January 18, 2022
Sponsor:
Information provided by (Responsible Party):
Alligator Bioscience AB

Tracking Information
First Submitted Date  ICMJE December 14, 2018
First Posted Date  ICMJE December 20, 2018
Last Update Posted Date January 18, 2022
Actual Study Start Date  ICMJE January 30, 2019
Actual Primary Completion Date March 3, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2018)
  • 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) ]
  • Pharmacokinetics: Time to Cmax [ Time Frame: 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) [ Time Frame: From start of study until end of study (28-56 days after last dose) ]
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ATOR-1015 First-in-human Study
Official Title  ICMJE 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
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor
  • Neoplasms
Intervention  ICMJE Biological: ATOR-1015
Bispecific human monoclonal antibody targeting cytotoxic T-lymphocyte associated protein 4 (CTLA-4) and OX40 (also known as CD134)
Study Arms  ICMJE Experimental: ATOR-1015
ATOR-1015 administered by intravenous infusions every 2 weeks until confirmed progressive disease, unacceptable toxicity or withdrawal of consent.
Intervention: Biological: ATOR-1015
Publications * Kvarnhammar AM, Veitonmäki N, Hägerbrand K, Dahlman A, Smith KE, Fritzell S, von Schantz L, Thagesson M, Werchau D, Smedenfors K, Johansson M, Rosén A, Åberg I, Winnerstam M, Nyblom E, Barchan K, Furebring C, Norlén 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2021)
33
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2018)
53
Actual Study Completion Date  ICMJE March 3, 2021
Actual Primary Completion Date March 3, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03782467
Other Study ID Numbers  ICMJE A-18-1015-C-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Alligator Bioscience AB
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Alligator Bioscience AB
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Malin Carlsson, MD Alligator Bioscience AB
Principal Investigator: Jeffrey Yachnin, Dr Centrum för Kliniska Cancerstudier (CKC), Karolinska Universitetssjukhuset
PRS Account Alligator Bioscience AB
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP