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Phase 1 Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of ATOR-1017

Sponsor
Alligator Bioscience AB (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04144842
Collaborator
(none)
50
Enrollment
3
Locations
1
Arm
43.9
Anticipated Duration (Months)
16.7
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study is to assess the safety and tolerability of increasing doses of ATOR-1017 when administered as repeated intravenous infusions to patients with advanced and/or refractory solid malignancies.

Condition or Disease Intervention/Treatment Phase
  • Biological: ATOR-1017
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 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 Solid Malignancies to Evaluate the Safety of Intravenously Administered ATOR-1017
Actual Study Start Date :
Dec 3, 2019
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: ATOR-1017

ATOR-1017 administered by intravenous infusions every 3 weeks until confirmed progressive disease, clear clinical deterioration, unacceptable toxicity or withdrawal of consent

Biological: ATOR-1017
ATOR-1017 is a human monoclonal antibody targeting 4-1BB (CD137)

Outcome Measures

Primary Outcome Measures

  1. Safety and tolerability: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 [From start of study until 28 days after last dose]

    Number of participants with treatment-related AEs assessed by CTCAE v 5.0

  2. Safety and tolerability: Dose-limiting toxicities (DLTs) [From first dose of ATOR-1017 (Day 1) until Day 21]

    Number of participants with DLTs

Secondary Outcome Measures

  1. Pharmacokinetics: Maximum observed serum concentration of ATOR-1017 (Cmax) [From start of study until end of study (28-56 days after last dose)]

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

  3. Pharmacokinetics: Area under the ATOR-1017 serum concentration-time curve (AUC) [From start of study until end of study (28-56 days after last dose)]

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

    Levels of antibodies to ATOR-1017 will be evaluated

  5. Clinical efficacy: Anti-tumor activity assessed by response evaluation criteria in solid tumors for immune-based therapeutics (iRECIST) [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Major Inclusion Criteria:
A patient is eligible to be included in the study if all the following criteria apply:

  • Has a diagnosis of advanced and/or refractory solid malignancy (histologically or cytologically documented)

  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • Has a minimum of one measurable tumor lesion

  • Has acceptable hematologic and clinical chemistry laboratory values

Major Exclusion Criteria:
A patient is excluded if any of the following criteria apply:

  • Has not recovered from AEs to at least grade 1 by CTCAE version 5.0 due to prior anti-cancer medications

  • Has symptomatic, steroid-dependent or progressive brain metastasis/metastases

  • Has a history of another primary malignancy, except for: a) Malignancy treated with curative intent and with no known active disease within 2 years prior to first dose of ATOR-1017, b) Adequately treated non-invasive basal skin cancer or squamous cell skin carcinoma, c) Adequately treated uterine cervical cancer stage 1B or less

  • Has an autoimmune disorder requiring immune modulating treatment during the last 2 years

  • Receives treatment with systemic immunosuppressant medication (except for inhaled and low dose systemic corticosteroids, i.e. ≤10 mg prednisolone or equivalent per day)

  • Is a female patient who is pregnant or nursing

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Oncology, Skåne University Hospital Lund Sweden SE-221 85
2 Fas 1-enheten, Centrum för Kliniska Cancerstudier, Karolinska Universitetssjukhuset Solna Sweden SE-171 64
3 Department of Oncology, Uppsala University Hospital Uppsala Sweden SE-751 85

Sponsors and Collaborators

  • Alligator Bioscience AB

Investigators

  • Study Director: Sumeet Ambarkhane, MD, Alligator Bioscience AB
  • Principal Investigator: Gustav Ullenhag, Dr, Department of Oncology, Uppsala University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alligator Bioscience AB
ClinicalTrials.gov Identifier:
NCT04144842
Other Study ID Numbers:
  • A-19-1017-C-01
First Posted:
Oct 30, 2019
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Aug 18, 2022