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Completed

NCT Number: NCT03782467

Phase 1 Study in Patients With Advanced and/or Refractory Solid Malignancies to Evaluate the Safety of 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.

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Key information

Conditions

Solid Tumor Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Phase 1 Unit, Department of Oncology, Rigshospitalet, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ATOR-1015

Biological

Bispecific human monoclonal antibody targeting cytotoxic T-lymphocyte associated protein 4 (CTLA-4) and OX40 (also known as CD134)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Alligator Bioscience AB

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 20, 2018
Registry last updated
Aug 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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