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

NCT ID: NCT04144842

Last Updated: 2023-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-03

Study Completion Date

2023-03-29

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumor Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ATOR-1017

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

Group Type EXPERIMENTAL

ATOR-1017

Intervention Type BIOLOGICAL

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

Interventions

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ATOR-1017

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alligator Bioscience AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sumeet Ambarkhane, MD

Role: STUDY_DIRECTOR

Alligator Bioscience AB

Gustav Ullenhag, Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Oncology, Uppsala University Hospital

Locations

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Department of Oncology, Skåne University Hospital

Lund, , Sweden

Site Status

Fas 1-enheten, Centrum för Kliniska Cancerstudier, Karolinska Universitetssjukhuset

Solna, , Sweden

Site Status

Department of Oncology, Uppsala University Hospital

Uppsala, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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A-19-1017-C-01

Identifier Type: -

Identifier Source: org_study_id

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