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

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