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

Phase 1

Completed

• Conditions: Solid Tumor; Neoplasms

• Registration Number: NCT04144842
• Lead Sponsor: Alligator Bioscience AB

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-08
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-30
• Study Start: 2019-12-03
• Status Verified: 2022-08
• Primary Completion: 2023-03-29
• Study Completion: 2023-03-29
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)
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)	Computed tomography (CT) scans of tumors will be evaluated according to iRECIST
Immunogenicity: Anti-drug antibody (ADA) titer in serum	From start of study until end of study (28-56 days after last dose)	Levels of antibodies to ATOR-1017 will be evaluated
Pharmacokinetics: Maximum observed serum concentration of ATOR-1017 (Cmax)	From start of study until end of study (28-56 days after last dose)

Trial Locations

Locations (3)

Department of Oncology, Skåne University Hospital; 🇸🇪 Lund, Sweden

Fas 1-enheten, Centrum för Kliniska Cancerstudier, Karolinska Universitetssjukhuset; 🇸🇪 Solna, Sweden

Department of Oncology, Uppsala University Hospital; 🇸🇪 Uppsala, Sweden