Study of Samalizumab in Patients With Advanced Cancer



Status:Terminated
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/20/2018
Start Date:November 17, 2016
End Date:September 27, 2017

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A Multicenter, Dose-Escalation, Phase 1 Study of Samalizumab (ALXN6000) to Evaluate the Pharmacokinetics, Safety, and Tolerability in Patients With Advanced Cancer

This is a multicenter, open-label, dose-escalation, Phase 1 study of intravenous (IV)
samalizumab to determine its maximum tolerated dose (MTD), overall safety/tolerability,
pharmacokinetic and pharmacodynamic parameters, and efficacy in participants with advanced
cancer. The study was terminated for administrative reasons and not due to any safety
concerns.


Inclusion Criteria:

1. Male or female participant was ≥ 18 years of age at Screening.

2. Eastern Cooperative Oncology Group performance status of 0 to 2.

3. Participant had advanced/metastatic cancer with disease progression after treatment
with all available therapies known to confer clinical benefit.

4. Participant had a life expectancy of greater than 12 weeks.

Exclusion Criteria:

1. Participant had a symptomatic brain metastasis.

2. Participant had active gastrointestinal bleeding as evidenced by either hematemesis or
melena.

3. Participant had acute gastrointestinal ulcers.

4. Participant had a history of any cancer other than the present condition (except
nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete
remission and off all therapy for that disease for a minimum of 3 years.

5. Participant with a condition requiring systemic treatment with either corticosteroids
or other immunosuppressive medications within 14 days of study drug administration.

6. Participant had an active infection requiring therapy.

7. Participant's serum was positive for the presence of hepatitis B surface antigen,
antibodies to hepatitis C virus, or antibodies to human immunodeficiency virus 1/2.

8. Participant had significant cardiovascular impairment (history of New York Heart
Association Functional Classification system Class III or IV) or a history of
myocardial infarction or unstable angina within the past 6 months prior to study drug
treatment.

9. The participant's most recent test values within 14 days before the date of entry met
the following standards:

- Bone marrow function: neutrophil count ≤1500/millimeter (mm)^3, hemoglobin ≤9.0
grams/deciliter, platelet count ≤100,000/mm^3.

- Liver function: total bilirubin ≥1.5 x the upper limit of normal (ULN) based on
the standard value of each institution, aspartate aminotransferase and alanine
aminotransferase ≥2.5 x ULN based on the reference laboratory.

- Renal function: serum creatinine ≥1.5 x ULN based on the reference laboratory.

10. Participant had ongoing immune-stimulated adverse events from other immunotherapies
(for example, pneumonitis, thyroiditis, or hepatitis) or a history of pneumonitis.

11. Participant had received chemotherapy, targeted therapy, and/or immunotherapy within
the 28 days prior to first dose of study drug, or within a Washout Period for the
chemotherapy, targeted therapy, and/or immunotherapy of 5 half-lives, whichever
occurred first.

12. Participant had toxicities from previous immunotherapy that had not resolved to Grade
1.
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