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

A

Alligator Bioscience

Status and phase

Completed
Phase 1

Conditions

Solid Tumor
Neoplasms

Treatments

Biological: ATOR-1017

Study type

Interventional

Funder types

Industry

Identifiers

NCT04144842
A-19-1017-C-01

Details and patient eligibility

About

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.

Enrollment

27 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

27 participants in 1 patient group

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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