ATOR-1015 First-in-human Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03782467 |
Recruitment Status :
Completed
First Posted : December 20, 2018
Last Update Posted : January 18, 2022
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Condition or disease | Intervention/treatment | Phase |
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Solid Tumor Neoplasms | Biological: ATOR-1015 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
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 : | January 30, 2019 |
Actual Primary Completion Date : | March 3, 2021 |
Actual Study Completion Date : | March 3, 2021 |
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.
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Biological: ATOR-1015
Bispecific human monoclonal antibody targeting cytotoxic T-lymphocyte associated protein 4 (CTLA-4) and OX40 (also known as CD134) |
- Safety and tolerability: Adverse events (AEs) assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
- Pharmacokinetics: Maximum observed serum concentration of ATOR-1015 (Cmax) [ Time Frame: From start of study until end of study (28-56 days after last dose) ]
- Pharmacokinetics: Time to Cmax [ Time Frame: 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) [ Time Frame: From start of study until end of study (28-56 days after last dose) ]
- Immunogenicity: Anti-drug antibody (ADA) titer in serum [ Time Frame: 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) [ Time Frame: 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03782467
Denmark | |
Phase 1 Unit, Department of Oncology, Rigshospitalet | |
Copenhagen, Denmark, DK-2100 | |
Center for Cancer Research, Department of Oncology, Herlev Hospital | |
Herlev, Denmark, DK-2730 | |
Sweden | |
Kliniska Prövningsenheten, Kliniska Studier Sverige - Forum Söder, Skånes Universitetssjukhus | |
Lund, Sweden, SE-221 85 | |
Centrum för Kliniska Cancerstudier (CKC), Fas 1-enheten, Karolinska Universitetssjukhuset | |
Solna, Sweden, SE-171 64 | |
Onkologavdelningen, Akademiska Sjukhuset | |
Uppsala, Sweden, SE-751 85 |
Study Director: | Malin Carlsson, MD | Alligator Bioscience AB | |
Principal Investigator: | Jeffrey Yachnin, Dr | Centrum för Kliniska Cancerstudier (CKC), Karolinska Universitetssjukhuset |
Responsible Party: | Alligator Bioscience AB |
ClinicalTrials.gov Identifier: | NCT03782467 |
Other Study ID Numbers: |
A-18-1015-C-01 |
First Posted: | December 20, 2018 Key Record Dates |
Last Update Posted: | January 18, 2022 |
Last Verified: | April 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |