Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    ator-1015
Previous Study | Return to List | Next Study

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: N/A
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
Actual Primary Completion Date : March 3, 2021
Actual Study Completion Date : March 3, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Layout table for location information
Denmark
Phase 1 Unit, Department of Oncology, Rigshospitalet
Copenhagen, Denmark, DK-2100
Center for Cancer Research, Department of Oncology, Herlev Hospital
Herlev, Denmark, DK-2730
Sweden
Kliniska Prövningsenheten, Kliniska Studier Sverige - Forum Söder, Skånes Universitetssjukhus
Lund, Sweden, SE-221 85
Centrum för Kliniska Cancerstudier (CKC), Fas 1-enheten, Karolinska Universitetssjukhuset
Solna, Sweden, SE-171 64
Onkologavdelningen, Akademiska Sjukhuset
Uppsala, Sweden, SE-751 85
Sponsors and Collaborators
Alligator Bioscience AB
Investigators
Layout table for investigator information
Study Director: Malin Carlsson, MD Alligator Bioscience AB
Principal Investigator: Jeffrey Yachnin, Dr Centrum för Kliniska Cancerstudier (CKC), Karolinska Universitetssjukhuset
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Alligator Bioscience AB
ClinicalTrials.gov Identifier: NCT03782467    
Other Study ID Numbers: A-18-1015-C-01
First Posted: December 20, 2018    Key Record Dates
Last Update Posted: January 18, 2022
Last Verified: April 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No