Phase 1 Study in Patients With Advanced and/or Refractory Solid Malignancies to Evaluate the Safety of ATOR-1015

Alligator Bioscience

Status and phase: Completed; Phase 1

Conditions: Solid Tumor; Neoplasms

Treatments: Biological: ATOR-1015

Study type: Interventional

Funder types: Industry

Identifiers

NCT03782467

A-18-1015-C-01

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

ATOR-1015

Experimental group

Description:

ATOR-1015 administered by intravenous infusions every 2 weeks until confirmed progressive disease, unacceptable toxicity or withdrawal of consent.

Treatment:

Biological: ATOR-1015