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

NCT04144842 | Completed Phase 1

• 1 other identifier: A-19-1017-C-01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Solid Tumor; Neoplasms

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Pharmacokinetics: Maximum observed serum concentration of ATOR-1017 (Cmax)

  From start of study until end of study (28-56 days after last dose)

• Pharmacokinetics: Time to 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

  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)

  From start of study until end of study (28-56 days after last dose)

Study Arms (1)

ATOR-1017

EXPERIMENTAL

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

Interventions

ATOR-1017 BIOLOGICAL

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

ATOR-1017

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alligator Bioscience AB: lead

Study Sites (3)

Department of Oncology, Skåne University Hospital

Lund, SE-221 85, Sweden

Location

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

Solna, SE-171 64, Sweden

Location

Department of Oncology, Uppsala University Hospital

Uppsala, SE-751 85, Sweden

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Sumeet Ambarkhane, MD

  Alligator Bioscience AB

  STUDY DIRECTOR

• Gustav Ullenhag, Dr

  Department of Oncology, Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 30, 2019
• Study Start: December 3, 2019
• Primary Completion: March 29, 2023
• Study Completion: March 29, 2023
• Last Updated: April 24, 2023

Record last verified: 2022-08

Locations

SE (3)