Phase 1 Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of ATOR-1017

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04144842
• Other study ID #: A-19-1017-C-01
• Status: Completed
• Phase: Phase 1
• Start date: December 3, 2019
• Est. completion date: March 29, 2023

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 29, 2023
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Biological:
• ATOR-1017
ATOR-1017 is a human monoclonal antibody targeting 4-1BB (CD137)

Locations

Country	Name	City	State
Sweden	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

Sponsors (1)

Lead Sponsor	Collaborator
Alligator Bioscience AB

Country where clinical trial is conducted

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) v 5.0	Number of participants with treatment-related AEs assessed by CTCAE v 5.0	From start of study until 28 days after last dose
Primary	Safety and tolerability: Dose-limiting toxicities (DLTs)	Number of participants with DLTs	From first dose of ATOR-1017 (Day 1) until Day 21
Secondary	Pharmacokinetics: Maximum observed serum concentration of ATOR-1017 (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-1017 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-1017 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)