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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782467
• Other study ID #: A-18-1015-C-01
• Status: Completed
• Phase: Phase 1
• Start date: January 30, 2019
• Est. completion date: March 3, 2021

Study information

• Verified date: August 2022
• Source: Alligator Bioscience AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 3, 2021
• Est. primary completion date: March 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Biological:
• ATOR-1015
Bispecific human monoclonal antibody targeting cytotoxic T-lymphocyte associated protein 4 (CTLA-4) and OX40 (also known as CD134)

Locations

Country	Name	City	State
Denmark	Phase 1 Unit, Department of Oncology, Rigshospitalet	Copenhagen
Denmark	Center for Cancer Research, Department of Oncology, Herlev Hospital	Herlev
Sweden	Kliniska Prövningsenheten, Kliniska Studier Sverige - Forum Söder, Skånes Universitetssjukhus	Lund
Sweden	Centrum för Kliniska Cancerstudier (CKC), Fas 1-enheten, Karolinska Universitetssjukhuset	Solna
Sweden	Onkologavdelningen, Akademiska Sjukhuset	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Alligator Bioscience AB

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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	Pharmacokinetics: Maximum observed serum concentration of ATOR-1015 (Cmax)		From start of study until end of study (28-56 days after last dose)
Secondary	Pharmacokinetics: Time to Cmax		From start of study until end of study (28-56 days after last dose)
Secondary	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)
Secondary	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)
Secondary	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)