Clinical trial NCT04144842: Phase 1 Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of ATOR-1017
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Neoplasms
Lead sponsor: Alligator Bioscience AB
Sponsor class: INDUSTRY
First posted: 2019-10-30
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
timeFrame: From start of study until 28 days after last dose
measure: Safety and tolerability: Dose-limiting toxicities (DLTs)
timeFrame: From first dose of ATOR-1017 (Day 1) until Day 21
Secondary outcomes:
measure: Pharmacokinetics: Maximum observed serum concentration of ATOR-1017 (Cmax)
timeFrame: From start of study until end of study (28-56 days after last dose)
measure: Pharmacokinetics: Time to Cmax
timeFrame: From start of study until end of study (28-56 days after last dose)
measure: Pharmacokinetics: Area under the ATOR-1017 serum concentration-time curve (AUC)
timeFrame: From start of study until end of study (28-56 days after last dose)
measure: Immunogenicity: Anti-drug antibody (ADA) titer in serum
timeFrame: From start of study until end of study (28-56 days after last dose)
measure: Clinical efficacy: Anti-tumor activity assessed by response evaluation criteria in solid tumors for immune-based therapeutics (iRECIST)
timeFrame: From start of study until end of study (28-56 days after last dose)
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Oncology, Skåne University Hospital
city: Solna
country: Sweden
facility: Fas 1-enheten, Centrum för Kliniska Cancerstudier, Karolinska Universitetssjukhuset
city: Uppsala
country: Sweden
facility: Department of Oncology, Uppsala University Hospital
Study officials:
affiliation: Alligator Bioscience AB
name: Sumeet Ambarkhane, MD
role: STUDY_DIRECTOR
affiliation: Department of Oncology, Uppsala University Hospital
name: Gustav Ullenhag, Dr
role: PRINCIPAL_INVESTIGATOR
References: