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

Phase 1

Completed

• Conditions: Solid Tumor; Neoplasms
• Interventions: Biological: ATOR-1015

• Registration Number: NCT03782467
• Lead Sponsor: Alligator Bioscience AB

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-14
• Study First Submitted QC: 2018-12-19
• Study First Posted: 2018-12-20
• Study Start: 2019-01-30
• Primary Completion: 2021-03-03
• Study Completion: 2021-03-03
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ATOR-1015	ATOR-1015	ATOR-1015 administered by intravenous infusions every 2 weeks until confirmed progressive disease, unacceptable toxicity or withdrawal of consent.

Primary Outcome Measures

Name	Time	Method
Safety and tolerability: Vital signs	From start of study until end of study (28-56 days after last dose)	Vital signs include blood pressure, pulse rate, oxygen saturation and body temperature. Clinically significant abnormal findings will be reported as AEs.
Safety and tolerability: Physical examination	From start of study until end of study (28-56 days after last dose)	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.
Safety and tolerability: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0	From start of study until 28 days after last dose	Number of participants with treatment-related AEs assessed by CTCAE v5.0
Safety and tolerability: 12-lead electrocardiogram (ECG)	From start of study until end of study (28-56 days after last dose)	Clinically significant abnormal ECG findings will be reported as AEs.
Safety and tolerability: Clinical laboratory tests	From start of study until end of study (28-56 days after last dose)	Clinical laboratory tests include clinical chemistry, hematology, coagulation, hormones and urinalysis.

Secondary Outcome Measures

Name	Time	Method
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-1015 will be evaluated
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)
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

Trial Locations

Locations (5)

Phase 1 Unit, Department of Oncology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Center for Cancer Research, Department of Oncology, Herlev Hospital; 🇩🇰 Herlev, Denmark

Kliniska Prövningsenheten, Kliniska Studier Sverige - Forum Söder, Skånes Universitetssjukhus; 🇸🇪 Lund, Sweden

Onkologavdelningen, Akademiska Sjukhuset; 🇸🇪 Uppsala, Sweden

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