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

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

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms; Solid Tumor
• Intervention / Treatment: Biological: ATOR-1017

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, SE-221 85
    • Department of Oncology, Skåne University Hospital
  • Solna, Sweden, SE-171 64
    • Fas 1-enheten, Centrum för Kliniska Cancerstudier, Karolinska Universitetssjukhuset
  • Uppsala, Sweden, SE-751 85
    • Department of Oncology, Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 5.0	Number of participants with treatment-related AEs assessed by CTCAE v 5.0	From start of study until 28 days after last dose
Safety and tolerability: Dose-limiting toxicities (DLTs)	Number of participants with DLTs	From first dose of ATOR-1017 (Day 1) until Day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics: Time to Cmax		From start of study until end of study (28-56 days after last dose)
Clinical efficacy: Anti-tumor activity assessed by response evaluation criteria in solid tumors for immune-based therapeutics (iRECIST)	Computed tomography (CT) scans of tumors will be evaluated according to iRECIST	From start of study until end of study (28-56 days after last dose)
Pharmacokinetics: Maximum observed serum concentration of ATOR-1017 (Cmax)		From start of study until end of study (28-56 days after last dose)
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)
Immunogenicity: Anti-drug antibody (ADA) titer in serum	Levels of antibodies to ATOR-1017 will be evaluated	From start of study until end of study (28-56 days after last dose)

Collaborators and Investigators

• Sponsor: Alligator Bioscience AB

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2019
• Primary Completion (Actual): March 29, 2023
• Study Completion (Actual): March 29, 2023

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 30, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: A-19-1017-C-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No