Phase 1 Study in Patients With Advanced and/or Refractory Solid Malignancies to Evaluate the Safety of ATOR-1015

Study Overview
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Brief Summary
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The aim of the study is to investigate the safety and tolerability of ATOR-1015 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 and/or Refractory Solid Malignancies to Evaluate the Safety of Intravenously Administered ATOR-1015

Conditions
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Solid Tumor, Neoplasms

Intervention / Treatment
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* Biological: ATOR-1015


Participation Criteria
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Eligibility Criteria
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Major Inclusion Criteria: Diagnosis of advanced and/or refractory solid malignancy Eastern Cooperation Oncology Group (ECOG) performance status of 0 or 1 Life expectancy of at least 3 months Major Exclusion Criteria: Organ transplant recipient Active autoimmune disorder Other malignancy

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-1015<br>ATOR-1015 administered by intravenous infusions every 2 weeks until confirmed progressive disease, unacceptable toxicity or withdrawal of consent. | Biological: ATOR-1015<br>* Bispecific human monoclonal antibody targeting cytotoxic T-lymphocyte associated protein 4 (CTLA-4) and OX40 (also known as CD134)<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) v5.0 | Number of participants with treatment-related AEs assessed by CTCAE v5.0 | From start of study until 28 days after last dose | 
| Safety and tolerability: Vital signs | Vital signs include blood pressure, pulse rate, oxygen saturation and body temperature. Clinically significant abnormal findings will be reported as AEs. | From start of study until end of study (28-56 days after last dose) | 
| Safety and tolerability: Physical examination | Physical examination will as a minimum include examination of mouth, throat, lymph nodes, respiratory, cardiovascular system, abdomen, extremities, neurological system and skin. Clinically significant abnormal findings will be reported as AEs. | From start of study until end of study (28-56 days after last dose) | 
| Safety and tolerability: 12-lead electrocardiogram (ECG) | Clinically significant abnormal ECG findings will be reported as AEs. | From start of study until end of study (28-56 days after last dose) | 
| Safety and tolerability: Clinical laboratory tests | Clinical laboratory tests include clinical chemistry, hematology, coagulation, hormones and urinalysis. | From start of study until end of study (28-56 days after last dose) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum observed serum concentration of ATOR-1015 (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-1015 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-1015 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) |