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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Solid Tumor, Neoplasms

Intervention / Treatment
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* Biological: ATOR-1017


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ATOR-1017<br>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<br>* ATOR-1017 is a human monoclonal antibody targeting 4-1BB (CD137)<br>|

What is the study measuring?
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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: 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 | Levels of antibodies to ATOR-1017 will be evaluated | 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) |