Phase 1 Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of ATOR-1017
- Conditions
- Solid TumorNeoplasms
- Interventions
- Biological: ATOR-1017
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
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
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
- Arm && Interventions
Group Intervention Description ATOR-1017 ATOR-1017 ATOR-1017 administered by intravenous infusions every 3 weeks until confirmed progressive disease, clear clinical deterioration, unacceptable toxicity or withdrawal of consent
- 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: 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) 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
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