Clinical trial NCT02987504: Study of Samalizumab in Patients With Advanced Cancer
Official title: A Multicenter, Dose-Escalation, Phase 1 Study of Samalizumab (ALXN6000) to Evaluate the Pharmacokinetics, Safety, and Tolerability in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Cancer
Solid tumor
Phase 1
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2016-12-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number Of Participants Experiencing DLT Graded According To CTCAE Version 4.03, Observed In The Cycle 1 In Order To Meet The Objective Of Assessment Of The MTD
timeFrame: Safety monitoring began at the informed consent obtained and continued up to 28 days after the last dose of samalizumab or until new anti-tumor therapy, whichever was earlier.
measure: Maximum Plasma Concentration After Administration Of Samalizumab
timeFrame: 21 days in Cycle 1
measure: Area Under The Plasma Drug Concentration-time Curve After Administration Of Samalizumab
timeFrame: 21 days in Cycle 1
Secondary outcomes:
measure: Objective Response Rate Using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
timeFrame: Up to 2 Years
measure: Disease Control Rate Using RECIST 1.1
timeFrame: Up to 2 Years
measure: Duration Of Response
timeFrame: Up to 2 Years
measure: Progression Free Survival
timeFrame: Up to 2 Years
measure: Overall Survival
timeFrame: Up to last participant completing at least 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
state: Connecticut
city: Grand Rapids
country: United States
state: Michigan
city: San Antonio
country: United States
state: Texas
Study officials:
References: