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

Sponsor

Alligator Bioscience AB (Industry)

Overall Status

Completed

CT.gov ID

NCT03782467

Collaborator

(none)

Enrollment

Locations

Arm

25.1

Actual Duration (Months)

6.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor Neoplasms	Biological: ATOR-1015	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 30, 2019

Actual Primary Completion Date :

Mar 3, 2021

Actual Study Completion Date :

Mar 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ATOR-1015 ATOR-1015 administered by intravenous infusions every 2 weeks until confirmed progressive disease, unacceptable toxicity or withdrawal of consent.	Biological: ATOR-1015 Bispecific human monoclonal antibody targeting cytotoxic T-lymphocyte associated protein 4 (CTLA-4) and OX40 (also known as CD134)

Arm

Intervention/Treatment

Experimental: ATOR-1015

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

Biological: ATOR-1015

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

Outcome Measures

Primary Outcome Measures

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: 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: 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

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 [From start of study until end of study (28-56 days after last dose)]
Levels of antibodies to ATOR-1015 will be evaluated
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Phase 1 Unit, Department of Oncology, Rigshospitalet	Copenhagen	Denmark	DK-2100
2	Center for Cancer Research, Department of Oncology, Herlev Hospital	Herlev	Denmark	DK-2730
3	Kliniska Prövningsenheten, Kliniska Studier Sverige - Forum Söder, Skånes Universitetssjukhus	Lund	Sweden	SE-221 85
4	Centrum för Kliniska Cancerstudier (CKC), Fas 1-enheten, Karolinska Universitetssjukhuset	Solna	Sweden	SE-171 64
5	Onkologavdelningen, Akademiska Sjukhuset	Uppsala	Sweden	SE-751 85

Sponsors and Collaborators

Alligator Bioscience AB

Investigators

Study Director: Malin Carlsson, MD, Alligator Bioscience AB
Principal Investigator: Jeffrey Yachnin, Dr, Centrum för Kliniska Cancerstudier (CKC), Karolinska Universitetssjukhuset

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alligator Bioscience AB

ClinicalTrials.gov Identifier:

NCT03782467

Other Study ID Numbers:

A-18-1015-C-01

First Posted:

Dec 20, 2018

Last Update Posted:

Aug 18, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Aug 18, 2022